Tony Hagen is senior managing editor for The Center for Biosimilars

Tony Hagen

Nearly 24% of patients with cancer delayed screenings because of the coronavirus disease 2019 (COVID-19) pandemic, according to a recently released American Society of Clinical Oncology (ASCO) 

of 1142 individuals with current or past cancer diagnoses. The survey included 4012 individuals overall, including caregivers and family members.

the patient made the decision to cancel or delay a screening

 two-thirds of the time; 63% of patients who delayed or skipped screenings reported being concerned about these delays, ASCO said.

The survey addressed not only COVID-19 issues but also perceptions of how an individual’s race affects access to the best quality cancer care. ASCO said 59% of those surveyed agreed racism affects the quality of care an individual receives in the US health care system, 53% said Black Americans are less likely to have access to the same quality of cancer care as White Americans, and 19% said race affects a person’s likelihood of surviving cancer.

Non-White respondents were more likely to agree that race affects quality of care in the United States (Black, 76%; Hispanic, 70%; Asian, 66%; White, 53%), and Black adults are more likely than White adults to have not been scheduled for any cancer screening appointments during the COVID-19 pandemic (68% vs 61%).

The survey findings indicated 75% of respondents would be willing to participate in a clinical trial for cancer treatment if they had cancer; however, just 53% said they are knowledgeable about clinical trials, and 48% said they believe patients with cancer who participate in clinical trials do not receive the best possible care and “are just part of an experiment.”

Among patients with cancer who have limited their contact with others to avoid contracting COVID-19, 84% were White and 73% were Black. The survey said 49% of patients with cancer have made “a lot of sacrifices” in their daily living because of their higher risk for contracting COVID-19, with more Blacks indicating so than Whites (61% vs 47%).

Many also indicated they have not had enough emotional support (33%) or help (22%), such as for picking up medications, during the pandemic.

ASCO said two-thirds of family members and caregivers would like to do more to support their loved ones with cancer in both practical and emotional ways.

The types of effects on cancer care caused by the pandemic reported by those with current or past cancer included delayed visits (16%), doctor consultations made via telehealth instead of in person (15%), cancer monitoring tests delayed (12%), health coverage lost (2%), treatment such as surgery or radiation cancelled (2%), and treatment regimens changed (1%). ASCO said 68% reported no effects on cancer care as a result of COVID-19.

Articles

During the coronavirus disease 2019 (COVID-19) pandemic, patients are more likely to have delayed cancer screenings rather than their doctors and clinics. 

ASCO Survey Measures COVID-19 Effect on Cancer Treatment

There’s nothing stopping states from passing laws in restraint of competition, and this appears to have happened in the case of biosimilars, said Markus H. Meier, acting director for the Federal Trade Commission’s (FTC) Bureau of Competition.

“It was popular for a while for a lot of the industry—the originator [biologics] industry, to go to the states and try to seek state legislation that would make it more difficult for the uptake of biosimilars,” he said. “The FTC can’t stop that type of behavior. You have a constitutional right to petition government and to seek legislation that would disadvantage your competitor. And then if the legislature passes such a law, it’s not an antitrust violation.”

Meier spoke at the American Conference Institute’s 11th Summit on Biosimilars & Innovator Biologics. His discussion focused on the extent of the FTC’s powers to combat anticompetitive practices and its growing interest in the biosimilars marketplace, where pay-for-delay settlements between originator and biosimilars companies have aroused the FTC’s attention.

State legislation respecting biosimilars has been controversial because it appears to some critics that originator companies have advocated for such legislation to make it tougher, not easier, for biosimilars to become established. As of May 2019, 45 states and Puerto Rico had 

 governing biosimilar substitution requirements.

In approving biosimilars, the FDA certifies that they are as safe and efficacious as the originator drugs they are patterned after. The FDA also has power to grant interchangeable status for these products, meaning they can be given in place of original brand biologics to patients at the pharmacy without express permission from the prescribing doctors. “While these [state] laws ostensibly encourage substitution, many actually throw up impediments like requiring that doctors and patients be notified when a substitution occurs, a requirement not necessary for small-molecule drugs,” according to a 2018 

 by biosimilar manufacturer Boehringer-Ingelheim.

For this reason the FTC created the Competition Advocacy Program, which is intended to advocate against such legislative encroachments on free trade. “We try to make sure that governments understand the competitive implications of some of the types of legislation that sometimes people try to lobby for," Meier said.

On the whole, federal antitrust laws are intended to prevent private business practices that unreasonably restrain competition. The key word is “unreasonable,” Meier said, because many forms of legitimate business are in essence somewhat anticompetitive. “This is basically where all of the action in antitrust is: What is a reasonable restraint of competition, and what is unreasonable restraint of competition?”

Patents can restrain competition, “but clearly they’re not an unreasonable restraint on competition, nor is getting regulatory exclusivity, and nor is contracting. Exclusive contracts generally don’t run into trouble, but at some point those restraints on trade can become unreasonable.” That’s often left up to the courts to decide, Meier said.

The FTC is somewhat misunderstood in this regard, he said. It has been the object of criticism that it is against innovation and innovators in industry, merely because it is carrying out its duties to remove impediments to free trade. “We try to seek to promote innovation, and competition can often do that, and we are very concerned about that.

Aware that he was addressing a pharmaceutical industry group with many intellectual property attorneys included, Meier stated that as much as this audience wanted to increase the profitability of its biologics, “you might appreciate that we are on the watch for you as consumers to try to protect those interests and make sure that we have robust competition among biologics and biosimilars in the hopes that consumers get lower prices, better quality services and products, more choice, and more innovation.”

For more about what Meier said at the ACI meeting, 

Meier MH. The FTC, antitrust & biologics. Presented at: ACI 11th Summit on Biosimilars & Innovator Biologics; September 24, 2020.

The Federal Trade Commission's powers to bring antitrust actions are circumscribed by public versus private and what is vs isn't "reasonable," Markus H. Meier explained.

Meier Explains FTC's Power to Pursue Antitrust Activity

The Federal Trade Commission (FTC) is a branch of law enforcement that draws its power from, by US terms, virtually ancient legislation such as the Sherman Antitrust Act of 1890, and lately Congress has nudged the agency to investigate anticompetitive practices in the pharmaceutical industry, including biosimilars, more closely, according to Markus H. Meier, acting director for the FTC’s Bureau of Competition.

“Some policy makers in Washington have asked ‘Why is this happening?’ ‘Why haven’t we achieved the goals and hopes and dreams?’ And sometimes this leads some of the politicians to ask the FTC, ‘Why aren’t you doing anything about this?’ And so, we are taking a close, hard look at this,” Meier said at the American Conference Institute’s 11th Summit on Biosimilars & Innovator Biologics.

Since 2018, the FTC has been examining patent settlement agreements between companies, as a result of amendments to the Medicare Modernization Act requiring that companies that settle, including originator biologics and biosimilars companies, submit copies of their settlement agreements to the FTC and Department of Justice, Meier said.

“We do review those agreements, and I have a team of people who read every one of them and look for possible reverse payment [pay-for-delay] cases. The good news is that, for the most part, companies are doing it right, but there is always the possibility that companies don’t do that, and they push the boundaries off beyond where they’re allowed to go, and we may someday in the future bring a case involving a reverse payment. But we’ve got guidance on our website about the requirements under the Medicare Modernization Act amendments in 2018. There are penalties that Congress imposed for failing to file properly,” Meier told the conference audience, which included a large contingent of intellectual property attorneys from the biologics industry.

Pushing for greater competitiveness in the biologics marketplace is not a new emphasis at the FTC, but the interest in a free marketplace is as keen as ever and the biologics marketplace is under scrutiny, Meier said. That is illustrated in part by a joint FDA/FTC workshop earlier this year to collaborate on advancing biologics competition and overcome anticompetitive practices, he noted.

“We are working closely together to watch what’s happening in the space to try to understand if there are things, institutional things involving regulations, or potential law enforcement actions that we may need to bring, or things the FDA may need to do in terms of revising regulations, in such a way to make sure that we have robust competition in the biologic space,” he said.

The FTC has yet to bring a public enforcement action involving biologics in general or biosimilars in particular, he said. But he mentioned a few ongoing cases of interest to the FTC.

 (J&J), in which Pfizer has alleged anticompetitive practices in the use of rebates to prevent providers and pharmacy benefit managers (PBMs) from starting new patients on the company’s infliximab biosimilar (Inflectra). Inflectra has been on the US market since 2016 and has achieved a 10.5% market share. Meier said this is odd because the drug was introduced at a discount to J&J’s Remicade reference product at greater than 15% discount. The reason the biosimilar sales have not taken off, allegedly, is because J&J’s rebate deals specify that PBMs don’t get the rebates if they allow doctors to start new patients on the biosimilar. It’s assumed that patients already on the originator product are not going to want to switch to biosimilar if their conditions are stable, and PBMs would not want to lose the lucrative rebates they receive for patient maintenance on the originator biologic, Meier said.

“What’s interesting is that Pfizer is one of the largest drug companies in the world and yet it’s having problems, so maybe there’s really something going on here,” Meier said.

Re: Humira (Adalimumab) Antitrust Litigation

that AbbVie entered into reverse payment agreements with numerous biosimilar companies to delay adalimumab biosimilar competition until 2023. “They did a series of settlements, one after another, with 5 different companies. The settlements are very complicated, involving not just settlement in the United States, but settlement of patent cases all across Europe and other parts of the world.”

The plaintiffs in that case alleged AbbVie illegally restrained trade by entering into settlements with competing biosimilar manufacturers to parcel out geographic markets. In June 2020, the United States District Court for the Northern District of Illinois (Eastern Division) dismissed the case against AbbVie because antitrust law did not cover the type of allegations made. Meier said the plaintiffs are likely to appeal and the FTC is watching closely.

Some acts by companies in the biologics marketplace may go too far in preventing free market activity, according to Markus H. Meier, acting director for the Federal Trade Commission (FTC) Bureau of Competition.

FTC's Markus H. Meier Talks About Restraint of Trade in the Biosimilar Marketplace

Alexion’s follow-on ravulizumab product (Ultomiris) has received marketing authorization from Japan’s Ministry of Health Labor and Welfare for treatment of adults and children with atypical hemolytic uremic syndrome (aHUS).

Ultomiris is Alexion’s advance on its reference eculizumab (Soliris) product, which faces biosimilar competition. The company is currently 

 final authorization from the European Commission for a new formulation of Ultomiris that received a recommendation earlier this month from Europe’s Committee for Medicinal Products for Human Use (CHMP).

aHUS is a very rare disease that causes progressive harm to the kidneys and other vital organs by damaging blood vessel walls and causing blood clots. Ultomiris is a long-acting C5 inhibitor that is administered every 2 months for adults and children weighing at least 20 kg. The C5 protein is part of the body’s complement system, which stimulates the clearance of microbes and damaged cells from the body. Excess C5 activation can lead to damaging inflammation.

“The goal of aHUS treatment is to prevent the body from attacking its own immune system through inhibition of uncontrolled C5 complement activation,” Shoichi Maruyama, director of the Department of Nephrology, Nagoya University Hospital, Japan, said in a 

. “Importantly, Ultomiris demonstrated good control, while also offering more time between infusions, which provides a relevant difference to patients and providers.”

Many patients present with aHUS in the hospital setting and require supportive care, including dialysis, in the intensive care center. The prognosis for these patients is often poor, and with supportive care alone, 56% of adults and 29% of children will develop end-stage renal disease or die within a year of disease diagnosis, so a timely and accurate diagnosis in addition to treatment, is critical to improving patient outcomes. In 2 single-arm, open-label studies, ravulizumab demonstrated improved kidney function and normalization of hematologic measures including platelet count and lactate dehydrogenase (LDH).

In initial treatment periods (26 weeks), 54% of adults and 77.8% of children demonstrated complete thrombotic microangiopathy (TMA) response. Normalization of LDH was recorded in 77% of adults and 90% of children. Platelet count normalized in 84% of adults and 94% of children. Improved kidney function was observed in 59% of adults and 83% of children.

In the 52-week follow-up, an additional 4 adults and 3 pediatric patients had a complete, confirmed TMA response. The overall complete TMA response was 61% for adults and 94% for children.

Alexion also reported that a cohort of 10 pediatric patients with a history of eculizumab treatment experienced disease control with ravulizumab, demonstrating that switching from eculizumab “maintained disease control as evidenced by stable hematologic and renal parameters, with no apparent impact on safety.”

Adverse events of highest frequency noted were upper respiratory tract infection, diarrhea, nausea, fatigue, headache, nasopharyngitis, and pyrexia.

An advance is notched for the ravulizumab (Ultomiris) follow-on product from Alexion. Clinical findings in atypical hemolytic uremic syndrome (aHUS) are provided.

Alexion's Ultomiris Gains aHUS Indication in Japan

A flood of biosimilar products can be anticipated over the next 5 years, including insulins, completely reshaping the current biosimilar landscape of 28 approved and 17 marketed products, with a consequent shifting of the sands for originator drug products and their dominance, predicted Sean McGowan, MBA, senior director of Biosimilars for AmerisourceBergen, a drug wholesaler.

However, McGowan and other panelists in a discussion at 

®'s Patient-Centered Oncology Care® 2020 virtual conference agreed that there’s a lot of disconnect when it comes to harmonizing the objectives of multiple stakeholders to ensure biosimilar access at lowest-cost.

The biosimilar revolution is gathering speed and mass, and many of its systemic problems have to do with the growing competitiveness of the market and the inability to engineer solutions fast enough, McGowan said.

“I’m very optimistic about the biosimilar product category and its ability to deliver the same level of efficacy and safety [as innovator products] from a clinical perspective, but then also to drive significant cost savings for providers, patients, and the health system as a whole,” he said.

Bhavesh Shah, RPh, BCOP, a senior director in specialty pharmacy and oncology at Boston Medical Center Health System, agreed with McGowan that solutions to these problems are in the works. “Biosimilars are actually pretty important in the minds of many institutions because these are the low-hanging fruit that are going to bring a lot of savings to institutions immediately.” At Boston Medical, an estimated 90% of patients in oncology have been converted to biosimilars where biosimilars are available as treatments, he said.

Coronavirus disease 2019 (COVID-19) has stressed finances, causing major losses for the health care system and also a painful hit to the wallet for patients, but these factors may stimulate biosimilar uptake, panelists said. “I do think COVID-19 is actually going to bring up more aggressive biosimilar adoption because of the financials we’re seeing,” McGowan said.

Kashyap Patel, MD, panel moderator and co-chair of PCOC20, said the evidence backing that statement is seen in the patients who have lost jobs and insurance coverage and have not been able to continue with routine care or access screening owing to distancing precautions. Cancer progression is one unfortunate consequence of this interruption in care. “I do see that getting worse over the next 3 to 4 months as we enter the second wave [of COVID-19],” he said.

Patel is CEO of the Carolina Blood and Cancer Care Associates in Rock Hill, South Carolina, and said 6 months from now he expects biosimilars to have shaved 20% off his total drug spending, based on the discounts that are already available by using them. But operations would be less complicated if payer policies on biosimilars were better aligned with practice realities, he said. CMS will cover any approved biosimilar, but that doesn’t go for private payers, who tend to narrow the range of biosimilars available to providers based on the sourcing deals they have been able to obtain.

Speaking for the payer side of the argument was Karina Abdallah, PharmD, a strategist and outcomes expert with Blue Cross Blue Shield of Michigan. COVID-19 has been a distraction in terms of working to improve biosimilar access, she said, adding that formulary decisions must be based on business realities as well as clinical needs. “Most of our decisions have been based on, at the minimum, the inclusion of 1 biosimilar or 2 biosimilar options to kind of open up that market, but we take rebates into consideration, of course, because that does include getting it down to how much are we paying per claim, which then ultimately comes back to how we handle all of our premiums and also of our savings to make it affordable for patients.”

Payer decisions to restrict biosimilar access to a small number of available biosimilar products creates a problem for practices, Patel said. “If I have to keep 20 vials of each different biosimilar, it becomes difficult for us to manage.” Why can’t payers and providers sit down cooperatively and hammer out these problems? he asked.

McGowan said payer restrictions on biosimilar are an almost universal complaint among health care centers that administer biosimilars to patients. “I don’t think anybody was really talking about this when there were very few biosimilars in the market for several years. We really didn’t see competitive markets emerge until late 2018, early 2019, down into 2020. So, it’s kind of a double-edged sword, where there is choice, there is access, but then at the same time it’s on the clinicians and those who are directing pharmacy activities to have to manage carrying multiple biosimilars for the same indications.”

That said, widespread concern and discussion on this topic have led to some creative solutions, “where practices and health systems are getting more savvy and leveraging their technology, their IT infrastructure, their [electronic medical records], to kind of alleviate and address these issues,” McGowan said. “I think it’s just the complexity of the market and how fast the market is evolving, and how much more competitive each of these markets is becoming, and how quickly some of these products are coming to market. The speed of the evolution is happening a lot faster than I think the solutions can kind of address or alleviate them.”

Shah said a lot of education is needed on all sides to educate the different stakeholders on what kinds of dynamics are at play. “You know, providers are so busy trying to remember which trastuzumab they ordered for which patients last. It’s just not optimal. Then what happens is that we’ll get more denials, and it’s now impacting the provider negatively financially when we’re trying to promote cost savings.”

“But if we get ahead of it and talk to the payers, I think that really would be helpful,” he said. Further, there have been legislative actions that have attacked this problem from another angle. “What I’ve seen recently come about is certain states are putting together regulations or already have regulations that prevent payers from preferring one biosimilar over another and prevent a payer from preferring a reference product over a biosimilar. California is one of those states. There definitely are changes going on across the country, because we’re seeing this gaming of the system that’s happening for rebates, and it’s definitely not good for biosimilar adoption.”

Abdallah said Blue Cross Blue Shield is open to those discussions, but she defended the payer’s actions on biosimilars and said it, too, is working to create a market for these lower-cost drugs. “We were actually one of the first to really disrupt the market and go with a biosimilar-first approach. A lot of times we do forgo a very hefty rebate the originator product [company] is offering because we are looking to have adoption of biosimilars. I think that collaboration [with all stakeholders] is definitely something that a lot of payers are open to.”

A diverse panel from practice, payer, and wholesale perspectives convened at The American Journal of Managed Care®'s Patient-Centered Oncology Care® 2020 virtual conference to hash out one of the hottest issues in biosimilar availability right now.

Stakeholders Joust Over Biosimilar Availability at PCOC20 

“The birth of biosimilars is incredibly important,” but payers are missing an opportunity to save money with them, said Debra Patt, MD, PhD, MBA, a practicing oncologist and breast cancer specialist in Austin, Texas, and executive vice president of Public Policy and Strategic Initiatives for Texas Oncology.

 2020 virtual conference, and she gave an overview of health care challenges facing the oncology profession and the broader health care community.

“What we have seen is that sometimes there are many biosimilars that enter into the market and that’s a challenge, because what we‘ve encountered is that frequently insurance companies will have a flavor-of-the-month biosimilar among the many choices,” Patt said.

“And if you have 8 biosimilars [for a single reference product], you can’t have insurance companies dictating you use a different biosimilar, because these are very expensive drugs, even if they’re lower cost than the innovator products, and it’s unrealistic to think you can keep multiple biosimilars of an innovator in inventory and manage that inventory at lower cost.”

Keeping all 8 biosimilars in inventory would be incredibly challenging, she explained.

“Payers would have a great strategy and a much lower cost if they’d just embrace any of the biosimilar choices,” Patt said.

In a discussion of President Donald Trump’s health care policies, Patt noted Trump’s midsummer executive orders to rein in the soaring cost of drugs with various initiatives, such as a proposal for index pricing, or benchmarking drug prices to lower cost, international standards; importing drugs from Canada to get around the pricing power of US-based pharmaceutical companies; and an attack on rebates by “eliminating kickbacks to middlemen.”

“So, there’s a strong interest in drug pricing reform and I would say that we’ve seen it on many fronts,” Patt said. Sizing up the 2020 presidential race, Patt said that no matter who is in office in 2021, there is likely to be a significant push for further health care reforms. Both the Trump and Biden election platforms include a health care emphasis, she said. “Drug pricing and cancer care and health care will be a central focus of the election and the next presidency.”

Incorporating new policies, especially when abruptly introduced into the health care system, is highly challenging, Patt said. She noted that more health care policies are likely imminent across the health care spectrum. That combined with dealing with the coronavirus disease 2019 will require flexibility

“We have a long path ahead of us, and it’s important for clinicians and others involved in health care to bridge and reach across to other disciplines to our partners, be it hospitals or insurance companies or administrators and others, to figure out how to navigate this new landscape. It will continue to provide challenges, and I imagine our challenges will be greater in the next few years to come,” Patt said.

Debra Patt, MD, PhD, MBA, discusses issues affecting biosimilar uptake at the Patient-Centered Oncology Care® 2020 virtual conference.

Patt: Payers Could Save More With Biosimilars

A global biosimilar trade association has issued a fresh call for regulatory authorities to streamline the application process for biosimilars by paring down the need for comparative clinical trials. “The decision to request a comparative clinical efficacy study should be based on a scientific evaluation assessing whether such a study would add scientific value to a given application,” the group contends.

The International Generic and Biosimilar Medicines Association (IGBA) said that technological advances have made the comparative trials requirement largely redundant and that regulatory authorities are clinging to an outdated process that prevents these lower-cost medicines from reaching market.

“Fostering a sustainable, multi-source medicines environment requires regulators to further streamline regulatory requirements for biosimilar approval,” the group 

. “Regulators should respond to advances in analytical science that provide more detailed and clinically-relevant information than was possible in the past by encouraging tailored clinical development programs to support approval of biosimilar medicines.”

The general approach to confirm biosimilarity to the reference product 

comprehensive structural and functional characterization of the biosimilar, a phase 1 study in healthy volunteers to assess pharmacokinetic (PK) comparability, and then a clinical efficacy trial to assess safety and effectiveness. These latter trials may be required in the United States and Europe to round out the evidence in support of a biosimilar approval appllication.

of biosimilars developed prior to 2010, in 95% of approvals in the European Union and the United States “the comparative efficacy study added no scientific value to the review process.” In the remaining 5%, differences between the biosimilar and reference product were noted in immunogenicity rates, requiring manufacturing process improvements, the IGBA said.

“Importantly, these outcomes were observed in biosimilars that were developed prior to 2010, after which time no differences in clinical efficacy and safety, including immunogenicity, have been observed,” the group wrote.

The same review article suggests a streamlined pathway to developing biosimilars that excludes comparative efficacy studies.

Based on such findings, the IGBA recommended that regulatory authorities “move away from routinely requiring comparative efficacy trials to support biosimilar approval.” This would be achievable because advances in science have enabled better analytical and functional characterization of biologics and insight into their performance, the group said.

“If critical physicochemical and functional quality attributes of the biosimilar candidate are closely aligned to those of the reference product and comparative human pharmacokinetic and, if necessary, additional immunogenicity studies confirm that the biosimilar is equivalent to its reference biologic product, a scientific assessment should be undertaken to evaluate whether requesting a confirmatory comparative efficacy study will add scientific value,” the group said.

Current regulatory policies in the United States and Europe allow the waiver of the need for comparative efficacy studies if there are appropriate biomarkers to guide analysis of the respective clinical attributes of biosimilars and reference products; however, few biomarkers that achieve this purpose have been identified, making it difficult to get the comparative efficacy trial requirements waived, the IGBA said, quoting from the 

In part, the group based its demand for regulatory review streamlining on a recent 

in which investigators concluded that “comparative efficacy trials are neither an effective discriminating tool for the comparison of the biosimilar with the [reference product], nor an efficient use of limited resources.”

Authors of that study also recommended that extensive comparative analytical studies combined with a modest application package containing pharmacokinetic and pharmacodynamic data would be “sufficient to assess biosimilarity in most cases.”

In December 2019, the FDA issued guidance waiving clinical immunogenicity and comparative efficacy testing for biosimilar insulins that match the analytical and pharmacokinetic/pharmacodynamic characteristics of the reference drug, as 

by Sarfaraz Niazi, PhD, a biopharmaceutical entrepreneur and professor who also serves on the advisory board for The Center for Biosimilars®.

Bielsky MC, Cook A, Wallington A, et al. Streamlined approval of biosimilars: moving on from the confirmatory efficacy trial. 

The International Generic and Biosimilar Medicines Association (IGBA) seeks to limit the use of comparative clinical efficacy studies to support biosimilar equivalency applications.

IGBA Seeks Waiver of Comparative Clinical Efficacy Studies

Two bills in Congress meant to address “product hopping,” or the anticompetitive practice of introducing a changed product to steer consumers away from an older product and competing versions, illustrate the unique scrutiny that drug manufacturers are subjected to, panelists said at the American Conference Institute’s (ACI) 11th Summit on Biosimilars and Innovator Biologics.

“This is something that’s very specific to the drug industry,” said Melissa Brand, assistant general counsel and director of intellectual property for Biotechnology Innovation Organization, a large trade association.

“You don’t see this sort of thing when a company introduces a new brand of shoe and can’t say anything bad about the old shoes or has to keep marketing the old shoes; or every time a new smartphone comes out, you don’t see a company having to go out and still market its old phone product, so I think it emphasizes the scrutiny on the industry these days,” Brand said.

 were introduced in May 2019 and address product hopping, although there are important differences between the two, said David Korn, vice president of intellectual property and law with Pharmaceutical Research and Manufacturers of America.

Both bills address “hard switching,” which is when a pharmaceutical company introduces a follow-on product and discontinues an older-but-similar product, and “soft switching,” when a company introduces a follow-on product but “takes action to unfairly disadvantage the older product in a manner that impedes competition for generics or biosimilars,” Korn said.

Current law does not clearly address the practice of soft switching, “and having such a concept could raise significant uncertainty for companies when thinking about planning alternative versions—new innovations—after initial approval,” he asserted.

“Both bills could kill innovation by requiring manufacturers to demonstrate that actions with respect to subsequent innovative products are not as competitive,” he said.

The House bill exempts certain products from the definition of follow-on products, including ones that qualify for Hatch-Waxman Act product exclusivity protections, Korn said. “That’s not in the Senate bill.”

“The House bill also has an exemption for certain activities not constituting unfairly disadvantaging the earlier product under definition of the soft switch,” he added. This exemption covers truthful, nonmisleading promotional activity, and there’s no exemption for this in the Senate bill, Korn said.

“You can imagine a situation where someone comes up with an alternative version and raises a question about what they can or cannot say about what’s truthful and nonmisleading, so there are a lot of questions that would need to be considered,” Korn said.

The Senate bill also includes broader legal remedies, such as disgorgement of “unjust enrichment” gained by the manufacturer and “restitution,” or damages, whereas the House bill does not specify remedies but indicates that enforcement will be in accord with provisions of the Federal Trade Commission Act.

ACI panelist Karin Hessler, assistant general counsel for the Association for Accessible Medicines, a trade group representing large biosimilar developers and manufacturers, said that from the biopharmaceutical industry perspective, there’s a concern that that soft switches may become “overregulated,” and this may discourage innovation. 

“You may not see the sort of really beneficial follow-on products where someone has really improved a formulation or has a new route of administration, a new indication, so that’s something that I think is definitely a concern,” she said.

from House Judiciary Committee Chairman Jerrold Nadler (D-New York), in justification of the House legislation, explained that preexisting antitrust laws have been a poor fit for addressing product hopping abuses. “Unfortunately, courts have struggled to consistently apply the antitrust laws to this conduct. Moreover, antitrust litigation to address anticompetitive behavior in pharmaceutical markets is costly and slow, often taking years—if not decades—to stop the abusive behavior.

“HR-5133 would prohibit product hopping by establishing that it is an unfair method of competition in violation of the Federal Trade Commission Act. In doing so, not only would this legislation help deter such conduct in the first place—through the FTC’s ability to obtain equitable monetary relief—it would also expedite judicial proceedings by providing much needed clarity to the law,” Nadler said.

According to the Congressional Budget Office, the companion bills, if enacted, will save taxpayers more than half-a-billion dollars over a 10-year period, the statement said.

 for more coverage of the ACI virtual 2020 conference.

Brand M, Korn D, Hessler K, Pearson M. Biosimilars state of the union: regulatory and legislative developments impacting the biopharmaceutical industry. Presented at: ACI 11th Summit on Biosimilars & Innovator Biologics; September 23, 2020.

Two bills in Congress meant to address the anticompetitive practice of product hopping drew fire at the American Conference Institute's annual biosimilars conference.

Biopharmaceutical Industry Representatives Discuss Product Hopping Legislation

Eva Temkin, acting director for policy at the 

Office of Therapeutic Biologics and Biosimilars (OTBB), provided a snapshot of how the FDA's new office is faring

 in her keynote talk at the American Conference Institute’s 11th Summit on Biosimilars & Innovator Biologics.

The OTBB was established in 2018 to help usher the development of biosimilars and thereby lower health care spending and improve patient access. “What we really wanted to do was say, ‘We’re committed to this. We recognize that there are a lot of things that the agency can do to help this marketplace grow and become stable,’” Temkin said in the discussion that was moderated by Amanda Hollis, JD, a patent litigator with Kirkland & Ellis of Chicago. 

One of the OTBB’s missions was to explore the use of data based on studies of reference products abroad to help bring down the development cost for biosimilar companies seeking to launch products on the US market, where the emphasis has been on doing local studies with locally sourced reference product material.

Hollis noted in her questions that reference product sourcing for US biosimilar applications can amount to almost half the cost of developing biosimilars for this marketplace.

Temkin noted that broadening the scope of resources available to biosimilar manufacturers in this context remains, very much, a work in progress. “I think we have made some progress and we’re still working on it,” she said. Discussions with foreign regulators are a part of this ongoing effort she said.

The FDA is tracking roughly 570 drug development programs underway related to potential coronavirus disease 2019 (COVID-19) therapies and has reviewed 270 trials. The pandemic has caused a massive shift in FDA priorities, Hollis noted, in a series of questions about priorities, resources, and election year politics.

Temkin responded that the resources at the OTBB remain adequate to the task of reviewing biosimilar applications, although she is “always” looking to hire more staff. The office currently has a staff of about 24, including legal and scientific professionals.

Since the beginning of 2020, the FDA has approved 2 new biosimilars, down from 10 last year; 28 have been approved since 2015. Currently there are about 90 biosimilar development projects for roughly 35 reference products, Temkin said.

With so much work on the OTBB’s plate, Hollis asked how the OTBB prioritizes these projects and decides which to review first. “As with a lot of things in government, there are limited resources and a lot of needs. One thing we take very seriously is to get stakeholder input in how we prioritize,” Temkin responded.

Hollis also asked whether patents and pending patent expirations play any role in the FDA’s decisions on which product development projects to prioritize. Temkin said that is not a central focus at the FDA. “If that is something that folks feel is something that should be taken into consideration, I would certainly encourage people to submit comments.”

A current goal at the OTBB is improving the efficiency of the biosimilar and interchangeable biosimilar approval process, and Temkin’s office has sought to create a “more tangible understanding” of what the scientific needs are for granting approvals for biosimilars, and this has included making clear what types of evidence are not acceptable for the approval of biosimilars, she said.

Temkin E, Hollis A. Biosimilars and interchangeable products: insights on FDA's perspective on implementation. Presented at: ACI 11th 

Summit on Biosimilars & Innovator Biologics. September 23, 2020. 

The FDA's Office of Therapeutic Biologics and Biosimilars balances a large number of biosimilar development projects with limited resources and is making progress, says Eva Temkin, acting director of policy.

FDA's Eva Temkin Discusses Biosimilar Approvals at ACI

Recent attempts at reform across the biosimilar and generic drug landscape have not had unanimous support, legal experts noted at the American Conference Institute’s 11th Summit on Biosimilars & Innovator Biologics.

Last year, for example, California, enacted Assembly Bill (AB) 824, which enabled it to evaluate “pay for delay” settlements between biosimilar developers and reference product companies and bring enforcement actions for what it perceives as anticompetitive terms.

“That legislation is doing what the Supreme Court declined to do, which is impose a presumption that an agreement that includes certain terms has an anticompetitive effect,” said ACI panelist Karin Hessler, assistant general counsel for the Association for Accessible Medicines (AAM). The AAM has filed a series of court actions designed to overturn AB 824, but has thus far been

The AAM represents many large biosimilar developers and contends that California has improperly assumed the right to reject corporate settlements reached outside the state and also given itself leeway to impose excessive fines on individual companies (minimum of $20 million).

Another reason the pharmaceutical industry opposes this law is that it gives California the ability to review and evaluate all individual past settlements between drug companies, not just new settlements, said panelist David Korn, vice president of Intellectual Property and Law with the Pharmaceutical Research and Manufacturers of America.

If other states join in with regulations of their own, the operational environment for pharmaceutical companies could become far too restrictive, he said. “This should be left up to Congress, because if you have multiple state-based frameworks, it could create a patchwork [of laws] that would be harder to comply with.”

Hessler said there’s potential that patent settlements between companies will be “stifled” by this legislation. “If you have that sort of impact, then you may see generic and biosimilar companies not as frequently challenging patents, which ultimately could result in higher rather than lower drug prices,” she said.

In addition, California Governor Gavin Newsom has until the end of this month to sign or veto AB 852, a bill that would enable the state to contract for the manufacture of generic and biosimilar drugs. One of the driving thoughts behind this bill is that “there has to be a more viable pathway for producing an affordable insulin,” Hessler said.

The legal and pharmaceutical industries are watching this bill closely, the panel said.

“There are certainly provisions in the bill that talk about sales to California payers, but I think the assumption is that (drugs) would be distributed potentially nationally,” Hessler said.

Panelists at American Conference Institute's (ACI) 2020 virtual summit discuss California's legislative attempts to improve competition in the drug industry. 