Jackie Syrop

 a drug-pricing bill that targeted diabetes drug makers on June 2, 2017, state lawmakers set about right away creating a new, bipartisan bill (SB 539) that also hones in on pharmaceutical companies and pharmacy benefit managers (PBMs). SB 539 passed both the state Assembly and Senate on June 5, 2017, and this time the governor is reported to be 

When he vetoed the original bill, Sandoval said it posed serious risks of unintended and potentially detrimental consequences for patients and that it ignored the role PBMs play in drug pricing—an important issue because only 3 PBMs 

 80% of the US market. SB 539 addresses the role of PBMs in drug price increases.

The new bill forces drug makers to justify price hikes on diabetes medications and requires PBMs to disclose rebate information. SB 539 also forbids PBMs from punishing pharmacists for selling a less expensive alternative drug to patients. Like the previous vetoed bill, the new bill requires pharma companies to provide diabetes drug pricing information for posting on a government website, in addition to a list of sales reps in the state. Patient groups will be forced to disclose industry contributions.

If SB 539 becomes law, drug makers will have to disclose manufacturing, marketing, and advertising costs for essential diabetes drugs and the profits they earn from sales of those medications. The drug companies would have to disclose pricing history and PBM rebates; PBMs would have to disclose their total rebates negotiated for drugs on the formulary and the amounts they retain.

 for their practice of direct and indirect remuneration (DIR) fees, which can drive up prices for Medicare Part D beneficiaries and taxpayers. An investigation of DIR fees by the Community Oncology Alliance (COA) contends that of late, PBMs have turned DIR fees PBMs into an “abusive and overly broad back-door vehicle for clawing back additional monies and increasing their own profits.”

According to COA, PBMs charge performance-based DIR fees to pharmacies based on inappropriate quality metrics. These retroactive DIR charges “create a lack of transparency, as pharmacies cannot account for net prices of a drug claim until after the PBM takes back the DIR fee.” This price confusion is of special concern for community oncology practices because the high cost of specialty cancer drugs they dispense makes these medications an attractive target for PBMs. Rather than controlling drug costs, PBMs are actually driving them up, COA claims. The Pharmaceutical Care Management Association (PCMA), a trade group representing PBMs, strongly denied the report’s findings.

Pharmaceutical Research and Manufacturers of America, the pharma industry’s trade group, is urging the governor to veto the new bill, emphasizing that it will not help patients afford their medications or help patients get the same savings as their insurance company is getting—a reference to the large rebates and discounts insurance companies are receiving and “not passing on to patients at the pharmacy counter.”

PCMA, the trade group representing PBMs, is also lobbying against the bill, pointing out that its “costly fiduciary mandate” is similar to other bills that have been rejected by federal courts on constitutional grounds for conflicting with federal benefits laws. Furthermore, says PCMA, the bill would raise costs by giving drug companies inside information that would “empower them to collude with their competitors.”

Articles

Nevada Governor Brian Sandoval is supportive of bipartisan bill SB 539 after it hones in on both, the pharmaceutical companies and pharmacy benefit managers (PBMs).

Revised Nevada Bill Targets Transparency for PBMs, Pharma

A Nevada bill (SB 265) that would have required pharmaceutical companies that make diabetes drugs to disclose information on 

, profits, and costs and publicly post that information, was 

Republican Governor Brian Sandoval cited concerns over “nascent, unproven, and disruptive” changes to state healthcare policy in vetoing the bill, which was one of 20 pieces of legislation that the governor had to sign or veto or it would become law without his signature. The bill had passed the Nevada Senate 19-2 and the Assembly 26-14 in May.

The bill would have lowered the cost of certain essential diabetes drugs, such as insulin, by requiring companies that make the drugs to report costs of production and marketing along with any rebates they provided. Additionally, the bill included language that would have mandated pharmaceutical sales representatives to annually report details of interactions with physicians, including who they visited and what samples or gifts they provided.

Governor Sandoval said certain parts of the bill were “laudable” and “well-intentioned,” and sought to address legitimate concerns about access to affordable drugs. But he said that the bill posed serious risks of unintended and potentially detrimental consequences for patients in the state and could possibly lead to rising healthcare costs. “There must be compelling evidence that the benefits are worth the risks,” he said, before he would support a bill as “uncertain” as SB 265. Sandoval said the bill’s mandated 90-day notice of price increases could create a perverse incentive for some to stockpile drugs to maximize profits and give purchasers, wholesalers, and secondary distributors of drugs greater financial incentive to restrict access to drugs. The bill also failed to address the role played by pharmacy benefit managers (PBMs) in prescription drug prices, the governor said.

Sandoval noted he had received hundreds of constituent calls and letters and opposition to the bill from groups such as the Epilepsy Foundation and the Nevada Cancer Research Foundation.

The bill’s sponsor, state senator Yvanna Cancela (D-Las Vegas), said she was deeply disappointed in the governor’s decision to veto a bill with significant bipartisan support that would have potentially led the nation in taking on high drug costs. Nevada’s Senate majority leader Aaron Ford said that the governor’s veto had put the interests of major pharmaceutical companies ahead of the 1 million patients with diabetes and pre-diabetes.

Nevada bill SB 265, which would have required pharmaceutical companies that make diabetes drugs to disclose information on insulin pricing, profits, and costs, and to publicly post that information, was vetoed by Nevada Governor Brian Sandoval. Sandovol cited concerns over “nascent, unproven, and disruptive” changes to state healthcare policy.

Nevada Governor Vetoed Bill Targeting Diabetes Drug Prices

The potential cost savings offered by biosimilars may never be realized in the United States if reimbursement incentives are not implemented to ensure their adoption and long-term use. 

 to Molly Burich, associate director of public policy, Biosimilars, Pipeline and Reimbursement, Boehringer Ingelheim, 2 of the biggest challenges concern the inconsistent policies on biosimilars that have been implemented by CMS and the Medicare Part D “donut hole” coverage gap.

 of the potential savings that could be realized from widespread adoption of biosimilars vary from 20% to 40%; at the higher end of the range, those percentages suggest a savings of $66 billion by 2024. Burich argues that it is critical to ensure that the current reimbursement systems are appropriately structured to drive biosimilar uptake.

Citing inconsistency within the CMS rules, Burich says,

“Unfortunately, at the federal level, the CMS has implemented a series of inconsistent policies on biosimilars that may impact their uptake and savings potential.” All biosimilars for the same reference product are assigned 1 billing and payment code (called a J-code) by CMS and are reimbursed at a blended rate; this approach treats biosimilars as generic products, and assumes that they are equivalent to one another. However, CMS’ policy for Medicaid pricing takes the opposite approach: biosimilars will be considered branded products, and manufacturers will be required to pay the 23.1% rebate for branded products as mandated by the Affordable Care Act (ACA).

With respect to the Medicare Part D coverage gap, the so-called “donut hole” coverage gap for patients on Medicare Part D begins after the patient hits $3700 in drug spending in 2017. Once the patient spends $4950, she will leave the coverage gap, and her out-of-pocket drug cost will be significantly reduced for the rest of the year. Through the ACA’s mandated Coverage Gap Discount Program (CGDP), manufacturers must pay a 50% rebate for all branded drugs subject to the coverage gap. The CGDP excludes both generic and biosimilar drugs from being discounted, however. Burich says that the exclusion of biosimilars from the CGDP program means 2 things for patients: first, patients will have higher cost-sharing for biosimilars, and second, they will remain in the donut hole for longer periods. 

During the time that a patient is subject to the coverage gap, the 50% manufacturer’s rebate on branded drugs counts toward the patient’s true out-of-pocket (OOP) costs, a situation that moves the patient through the coverage gap faster. Being excluded from the CGDP, any discount offered on biosimilars under the plan would not count toward the patient’s true OOP costs; therefore, the patient would experience both a higher cost share 

 a longer gap in coverage than if she were using a branded drug. 

The coverage gap will close for patients in 2020, when patients will begin to pay 25% of the cost of branded or generic/biosimilar drugs once they reach the coverage gap. But the impact on the true OOP costs will still force patients to remain in the coverage gap for longer periods if they take biosimilars.

Burich believes that the exclusion of biosimilars from the CGDP means that costs to the plan will be higher through 2020 and beyond. The plan’s reimbursement responsibility for a brand product in the coverage gap will be 25%, while its responsibility for a generic product will be 75%. “The result of this policy makes it potentially very unlikely for a Part D sponsor to push the use of biosimilars under Medicare Part D,” Burich explains. It is also unlikely that Part D sponsors will expend much effort on the matter as long as patient and Part D plan financial disincentives exist.

What are potential solutions? Burich cites an 

 by Avalere Health that proposed 2 potential actions: first, allowing biosimilars to participate in the CGDP and pay the 50% rebate, and second, allowing CMS to create a new biosimilar tier to give Part D plans flexibility on how they manage biosimilars. Both approaches would require legislative action. The first is a more likely and timely solution, according to Burich, because it could be used for biosimilars that have been approved but that are not yet marketed under Medicare Part D. 

CMS is positioned to play a pivotal role in the development of policies, Burich states, that will allow biosimilars to realize their full potential in the United States. “Addressing the coverage gap in Part D is a critical place to start.”

The potential cost savings offered by biosimilars may never be realized in the United States if reimbursement incentives are not implemented to ensure their adoption and long-term use, according to industry expert Molly Burich.

Biosimilar Adoption Faces Serious Challenges Due to CMS Coverage Gap

The good news is that the issue of rising drug prices, once ignored by the pharmaceutical industry and Congress alike, is finally 

 as a serious problem. The bad news is that some pharma stakeholders are blaming other stakeholders, igniting what 

 calls a “civil war” among the most powerful players in the pharmaceutical industry, including the brand-name and generic drug makers, pharmacists, and pharmacy benefit managers (PBMs). The result, as the

 reported on May 29, 2017, is that lobbyists are crowding congressional offices and assigning blame for rising costs to others, especially to PBMs like CVS Health and Express Scripts, which manage the drug benefits of millions of Americans.

The pharma industry spends nearly twice as much as other US business sectors on congressional lobbying, and that amount has increased after President Trump’s January 2017 

 that the drug industry was “getting away with murder.” Despite having made this charge, however, President Trump has not presented any proposal of his own to curb drug price increases. His intentions are hard to read, as he has talked about reducing regulations even as he accused the industry of price fixing, and he named industry-friendly former Congressman Tom Price, MD, the head of HHS, and named former pharma consultant, Scott Gottlieb, MD, FDA Commissioner.

Although consumer rage has kept the issue of drug prices in the spotlight—as have well-publicized stories about suddenly 

 for EpiPens for severe allergic reactions and about the filing of a 

 accusing 3 big insulin producers of price collusion—members of Congress continue to meet with and accept millions of dollars in campaign contributions from industry lobbyists. According to the Center for Responsive Politics, the pharma and health products industry 

 $78 million on lobbying in the first quarter of 2017 alone, a 14% increase over such spending in 2016. The industry pays 1100 lobbyists—more than 2 lobbyists per member of Congress&mdash;and spent over $58 million on the 2016 election cycle, an expenditure that not only represented the biggest investment in the industry’s history but also a 20% increase over spending on the previous presidential election cycle.

The brand-name drug industry is the biggest player; it spends the most on campaign contributions and has the greatest number of lobbyists. Big pharma’s trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), increased its annual dues by 50% in order to generate an additional $100 million to fund advertising across social media, television, and print media, which in part serves to remind consumers of the industry’s life-saving drugs. Other PhRMA ads pin the blame for drug price increases on PBMs and health insurance companies.

 PBMs are launching their own counteroffensive. PBM trade group, the Pharmaceutical Care Management Association (PCMA), has a 

 to engage senior Trump administration officials and build “a firewall” on Capitol Hill, form a partnership with conservative advocacy groups, and run an advertising campaign. PCMA hosted hundreds of government and industry officials at a policy forum in Washington, DC, to explain how PBMs were positioned to save consumers money. A recent 

 from Express Scripts, one of the biggest PBMs, shifted the blame for the rising prices of oncology drugs to other factors, saying that spending on oncology medications had increased nearly 22% due to growth in both utilization and unit cost. “List prices for oral oncology drugs, which are not rebated or discounted to any significant extent, have doubled between 2011 and 2016, from $20 per unit to $40 per unit. Looking at the 39 medications on the market in 2010, 6 had 100% to 200% inflation rates, 1 had inflation greater than 300%, and 1 had inflation greater than 800%,” the statement said. A smaller war is playing out between PBMs and pharmacists, according to the same 

report, with lobbyists championing both sides through meetings and e-blasts.

 calls the response from members of Congress a “grab-bag” of options that would each help or hurt different industry players. For example, a current 

 would force brand-name drug makers to provide samples of their drugs to generic competitors, while another 

 would allow the import of low-cost medications from Canada. Further, 

 introduced by Doug Collins (R-GA) would force PBMs to increase drug pricing transparency.

 reports that industry lobbyists continue to host weekly events for members of Congress at private clubs and restaurants, helping to finance their reelection bids. An example was a PhRMA Industry Breakfast for Representative John Shimkus (R-IL), who in 2016 persuaded the Obama administration to stop a project intended to test ways to lower the cost of Medicare Part B drugs—a program pharmaceutical companies did not want to see implemented. Shimkus, who received nearly $300,000 in drug industry contributions in the last election cycle, led the challenge against the project. Shimkus said that his intention was to protect cancer patients, not the pharmaceutical industry, because a clinic in his district might have closed had the Medicare program gone into effect.

Members of Congress pushing to increase competition and reduce drug prices say that campaign fundraising by pharma lobbyists creates an uphill fight. Representative Lloyd Doggett (D-TX), who has been working on legislation to address drug pricing, said that the civil war in the pharma industry was a positive sign because the attention of Congress is at last focused on a problem about which so many of his constituents already know: price gouging.

Soaring Drug Prices Lead to Pharma Industry Finger-Pointing 

 Considerations in Demonstrating Interchangeability With a Reference Product (Docket FDA-2017-D-0154) ended on May 19, 2017. The 

 were submitted by manufacturers of biologics and biosimilars, third-party payers, pharmacy trade associations, and patient groups.

While most commenters congratulated the FDA on its flexible approach to interchangeability, many called on the agency to provide additional details about requirements for switching studies, the distinction between interchangeability and biosimilarity, guidelines for the use of foreign reference drugs in switching studies, and the requirements for showing interchangeability among all indications and all presentations. Commenters 

 about what interchangeability truly means, and asked whether interchangeability should be interpreted as a higher standard or simply as an additional data requirement.

 on biosimilar manufacturers to use so-called switching studies to determine the safety and efficacy of a biosimilar with respect to its reference product. Such studies would require that the comparator product should not be used as a control only, but should instead be used in both the active (switching) arm and the control (non-switching) arm of switching studies.

Furthermore, the guidance notes that using a non-US-licensed comparator product would not generally be appropriate. In its commentary, Pfizer disagreed with that recommendation, saying that such a practice has the potential to create practical challenges regarding where a switching study could be conducted; the Biosimilars Forum also said this aspect of the guidance could undermine the global nature of biosimilar development.

Many commenters expressed concern over whether the FDA will use labeling, nonproprietary naming, or another naming method that would indicate that a biosimilar is interchangeable. For example, the Hematology/Oncology Pharmacy Association (HOPA) said, “Considering that there may be differences in the criteria used to approve the drug, differences in approved indications, and differences in immunogenicity, it is important to have a name that allows providers to differentiate which drug they are actually using, or switching to.” HOPA underscored its previous recommendation that the drug name consist of the reference drug’s International Nonproprietary Name (INN) plus a meaningful suffix, and said the current FDA position of using an INN plus a random suffix is both confusing and unsafe.

Some commenters asked the FDA to explain its plan for post-marketing changes to reference drugs after findings of interchangeability. Commenters also 

 greater clarity and clearer direction from the FDA regarding interchangeability and multiple applications, given the abbreviated process for generic drug approvals and continuing confusion about the language of the Biologics Price Competition and Innovations Act [BPCIA], a legal quandary that has made its way to the Supreme Court for clarification).

AARP, Inc, which represents 38 million Americans over age 50, also weighed in, saying that the biosimilar approval pathway will only be fully utilized if the requirements for biosimilar approval are reduced relative to requirements for a traditional biologic license application. “If not,” says the organization, “companies could forgo biosimilar development entirely. Given manufacturers’ clear and growing interest in developing biologic drugs, it is difficult to overstate how much this outcome would negatively affect patients, payers, and taxpayers.” AARP’s overriding concern is that the BPCIA be implemented in a manner that ensures safety and efficacy without creating unnecessary barriers to the savings promised by the biosimilar approval pathway.

Comments on the FDA's Biosimilar Interchangeability Draft Guidance Highlight a Growing Need for Clarity 

FDA Commissioner Scott Gottlieb, MD, unveiled his 

 to slow drug price increases, in part by making it easier for generic drugs to be approved and increasing competition.

In an appearance before the House appropriations subcommittee, which is deciding on the FDA’s budget for next year, Gottlieb said his Drug Competition Action Plan would make it easier for generic drugs to enter the US market by accelerating the FDA’s review process, which has a current backlog of over 2600 applications. Gottlieb also called for a simpler approach to reviewing applications for biosimilars of complex biologic drugs, including Sanofi’s Lantus insulin and Mylan’s EpiPen. Gottlieb has previously advocated a faster path to marketing new and generic drugs.

Gottlieb’s plan might also receive a boost from the 

 on the FDA, which came to light during the hearing.

Acknowledging that the FDA does not play a 

 in drug pricing, Gottlieb said the agency can take steps to facilitate entry of lower-cost alternatives to the market and increase competition. Stating that legislative action would be needed to overhaul the drug approval process, Gottlieb noted that among the actions the FDA could take was reviewing situations in which brand-name drug makers try to slow approval of generic competitors. Both the Senate and House have introduced 

 that would allow generic drug makers to sue brand counterparts.

Gottlieb also said that the Risk Evaluation and Mitigation Strategy (REMS) program, which allows the FDA to require drug makers to prove that a drug’s benefits outweigh its risks, was being manipulated by the pharmaceutical industry and used to slow the introduction of generic competition. He said the FDA was evaluating whether to waive REMS requirements more easily than the agency has in the past.

 notes that drug companies with older and competition-prone medications, more than firms with newer drugs, will have more to fear from faster generic approvals and changes made to the legal and regulatory tactics that are used to extend a drug’s sale period. Companies that rely on biologics—which are among the bestsellers worldwide but that have faced little or no generic competition in the United States&mdash;will also be more concerned with such changes. If biosimilar approvals speed up, the biggest losers may be specialty pharma, which tend to have older products and smaller markets.

A spokesman for the pharmaceutical industry group Pharmaceutical Research and Manufacturers of America said the group is committed to working with the Trump administration and Congress on market-based reforms that would encourage generic competition and promote biopharmaceutical innovation.

 for the FDA seeks a last-minute renegotiation of user fees to make up for an approximate 30% decrease in the FDA’s budget. The President’s call for over $1 billion in new user fees to replace losses from his proposed budget cuts was made even though the House and Senate have already both agreed upon their respective versions of user fee reauthorization legislation that contain the user fees already agreed to by the FDA, the pharmaceutical industry, generic drug and biosimilar makers, and medical device manufacturers.

Senator Lamar Alexander (R-TN) told HHS Secretary Tom Price that it was too late for the Trump administration to have an impact on this year’s user fee reauthorization bills. Industry group representatives including BIO and AdvaMed told Senate officials that a failure to act on the already agreed-upon reauthorizations would be devastating.

FDA Commissioner Gottlieb Will Work in a Variety of Ways to Contain Drug Prices

Ahead of today's review of Retacrit, Pfizer’s proposed biosimilar of Amgen’s epoetin alfa (Epogen) by the FDA’s Oncologic Drugs Advisory Committee (ODAC), committee members expressed 

 of the drug’s similarity to the reference drug Epogen.

 posted on the FDA website, agency reviewers called Pfizer’s product “highly similar” to Amgen’s Epogen (and Johnson & Johnson’s Procrit, which is the same drug but is marketed for different uses under a licensing arrangement with a California biotech), and wrote that despite minor differences in clinically inactive components, the similarity stood. They further state that there are no clinically meaningful differences between the biosimilar and reference products in terms of the safety, purity, and potency. Pfizer hopes to gain approvals for Retacrit in each of Epogen’s 4 indications:

Anemia due to chemotherapy in patients with cancer

Anemia due to zidovudine in HIV-infected patients

To reduce the need for allogeneic red blood cell transfusions in patients at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery.

If approved, Retacrit will be Pfizer’s second biosimilar to be marketed in the United States. Inflectra, Pfizer’s biosimilar of infliximab (Remicade), was approved in 

. If approved, Retacrit would also be the second biosimilar approval to compete directly with an Amgen reference biologic product. Amgen is already facing competition from filgrastim-sndz (Zarxio), an approved 

Retacrit’s approval, while likely, is not assured. Retacrit has faced prior regulatory denial: in 2015, the FDA issued a complete response letter to Pfizer following Pfizer’s acquisition of Hospira, which had developed the drug. And even if Retacrit is approved, a 

 with Amgen looms over the marketing of Retacrit. Amgen is 

 in federal court to block the launch of Retacrit, alleging that Hospira provided Amgen with notice of commercial launch too soon in the “patent dance” process laid out in the Biologics Price Competition and Innovation Act.

Epogen and Procrit are blockbuster drugs, with each earning over $1 billion in worldwide sales in 2016. Another Epogen biosimilar is likely to add to the competition with Amgen: Sandoz is also preparing to submit an application to the FDA for its Epogen biosimilar.

 that ODAC recommended approval of the company's epoetinalpha biosimilar across all the indications listed above. the recommendation will come into play when the FDA evaluates Pfizer's Biologics Licence Application for the proposed epoetin alfa biosimilar.

Pfizer's Epogen Biosimilar Called "Highly Similar" to Reference Drug

The Nevada state senate passed a bipartisan bill (

) that would force pharmaceutical companies that make diabetes drugs to disclose information on their insulin pricing, profits, and costs, and would require state government to publicly post the information online.

 by a 19 to 2 vote and now heads to the Nevada assembly. The measure, which focuses on transparency, contains some of the 

 on pharmaceutical companies in the nation. The price of insulin has also been the subject of a class action 

, which alleges price fixing among 3 insulin makers. Nevada Republicans said they joined the Democratic majority in favor of the bill because they support the notion of transparency. Nevada’s governor, Republican Brian Sandoval, has not ruled out signing the bill.

The bill’s sponsor, Senator Yvanna Cancela (D-Las Vegas), argues that, if nothing else, detailed pricing data would start a conversation among state and federal lawmakers as well as patients. Cancela said the disclosure process equips patients with information with which to ask questions and push back against price gouging. The bill’s sponsors removed a provision from the original proposal that would have required drug makers to publish their research and development costs. They also removed a provision to require insulin makers to issue refunds to insurance companies and patients who purchase insulin if annual price increases surpass inflation because they were concerned with its legality.

The Pharmaceutical Research and Manufacturers Association (PhRMA), a lobbying group, is opposed to the Nevada measure and says it is dangerous and will not do anything to help patients in the state access or afford their medications. A PhRMA spokesperson said drug rates constantly fluctuate and the market is much more complex than supporters of the bill claim. The organization believes the bill could backfire on patients.

The Nevada senate bill sets forth a number of requirements, including the annual publication of a list of prices the drug makers set, what profit they make from sales of insulin, and the total amount of insulin discounts given to market middlemen. The state’s HHS must place this information publicly on its website. The bill also requires that drug companies notify the state 90 days before making any changes in insulin prices.

In addition, nonprofit organizations operating in Nevada that advocate on behalf of patients or that fund medical research must report to the state HHS any information concerning contributions they received from drug manufacturers, insurance companies, or pharmacy benefit managers. The bill also authorizes the state’s HHS to impose an administrative penalty in certain circumstances and also requires private schools and employers to allow pupils and employees to keep and self-administer certain drugs.

New Bill in Nevada Spotlights Ambiguity in Insulin Pricing

Celltrion, the sponsor of a biosimilar of Roche’s rituximab (MabThera/Rituxan) approved in the European Union (EU), 

 from the EU’s Committee for Medicinal Products for Human Use (CHMP) to market the drug under 3 more names: Tuxella, Ritemvia, and Blitzima. Celltrion’s rituximab is already marketed in Germany under the name Truxima. Marketing authorizations for some of the names are slightly different; for example, Ritemvia has an indication for chronic lymphocytic leukemia, whereas Blitzima and Tuxella do not have that indication.

The European Commission will decide whether to approve the CHMP’s decision in a few weeks. Truxima is the first Rituxan biosimilar approved by the European Medicines Agency (EMA) and the 

 to be approved for a cancer indication. Truxima’s label indicates it can be used for the treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, in addition to autoimmune disorders.

The action to secure additional names for Truxima generated surprise among some market experts and commentators, and drove speculation about Celltrion’s strategy, which may revolve around generating more total market share through multiple names for the product. Several years ago, Celltrion gained 2 marketing authorizations for its biosimilar to Merck’s infliximab (Remicade) and later sold one of them to Hospira. Celltrion marketed its own product as Remsima, and Hospira marketed its drug as Inflectra. In some markets the competition resulted in biosimilar rituximab selling at a 70% discount to the branded Remicade, eliminating the brand from some Nordic markets where prices were at their lowest.

In the case of its biosimilar rituximab, Celltrion may be setting up the company to have more choices and potentially giving itself the opportunity to give out rights to several different companies, who would compete against each other and maximize market share for Celltrion head of biosimilar rivals. Sandoz recently received a recommendation for approval from the CHMP to market its biosimilar rituximab, creating a likely rival drug launch for rituximab in only a few weeks.

South Korea—based Celltrion has indicated it may apply for FDA approval for rituximab by June 2017. If approved, it would be 

 in the United States by Celltrion’s US commercial partner, Teva Pharmaceuticals.

Rituxan is the world’s second top-selling drug, with sales of more than $7 billion in 2016.

Celltrion to Play With 4 Brand Names in the EU With Rituximab Biosimilar 

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a 

 for the marketing authorization of Insulin lispro Sanofi, biosimilar to Eli Lilly’s originator product insulin lispro (Humalog).

 the use of Insulin lispro Sanofi (100 Units/mL) to treat adults and children who have diabetes and need insulin to keep their blood sugar level controlled, including patients whose diabetes has just been diagnosed. The EU is expected to make a final decision on the product’s marketing authorization in the coming months.

 on Sanofi’s clinical development program that enrolled over 1000 adults with type 1 or type 2 diabetes. The program included a pharmacokinetic/pharmacodynamics phase 1 study, which evaluated the product’s similarity in exposure and activity compared with insulin lispro 100 Units/mL as currently approved in the US and European Union (EU), and 2 

 phase 3a clinical trials (SORELLA 1 and SORELLA 2) that evaluated its safety and efficacy compared with insulin lispro 100 Units/mL as currently approved in the US and EU in adults with type 1 or type 2 diabetes. In addition, a safety study was conducted with the lispro biosimilar used in insulin pumps in adults with type 1 diabetes.

Insulin lispro’s patent expired in 2013 and there is 

 version of the product in the United States. Sanofi’s insulin lispro product, SAR 342434, completed phase 3 trials in 2016. Data from the trials 

 that SAR 342434 is equally safe and effective as insulin lispro plus insulin glargine in patients with type 1 diabetes. Other insulin lispro biosimilar candidates in the research pipeline are in much earlier phases of clinical trials than the Sanofi candidate.

The only FDA-approved biosimilar of an insulin product in the United States is Eli Lilly’s Basaglar, a biosimilar of insulin glargine (Sanofi’s Lantus), which was 

 by the FDA in late 2015. Strictly speaking, Basaglar is not a biosimilar but rather is referred to as a “follow-on” insulin. Hormones and human growth hormones are approved by FDA under a different path than biologics because they are regulated as drugs, not biologic products.    

The lower cost of biosimilar insulins is expected to increase access to insulin analogs such as insulin lispro, providing more tailored treatment and improved health outcomes for the nearly 6 million Americans with diabetes who rely on insulin. With the introduction of insulin glargine, a savings of approximately 15% off list price of brand-named insulin glargine occurred.