The Center for Biosimilars Staff

 from the SMi Biosimilars North America 2017 conference. 

Articles

Our latest infographic covers 4 key takeaways from the SMi Biosimilars North America 2017 conference. 

Infographic: 4 Takeaways From the SMi Biosimilars North America 2017 Conference

Hi, I’m Kelly Davio for The Center for Biosimilars

, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars. 

Here are the top 5 biosimilars articles for the week of November 20.

The European Medicines Agency will move to Amsterdam, Netherlands

, after European ministers voted on the agency’s post-Brexit relocation. 

Number 4: A recently published case study shows that a non-medical switch to biosimilar infliximab was 

associated with a rapid loss of treatment response

 in multiple patients with Behçet's disease. 

Number 3: Samsung Bioepis has been granted 

the first European marketing authorization for a trastuzumab biosimilar

Number 2: Stacie Phan, president of the Biosimilars Forum, 

explains the critical need for US physicians to gain better education on biosimilar therapies.

Number 1: Swiss drug maker Roche has sued biosimilar developer Pfizer 

over its proposed trastuzumab biosimilar.

Finally, last week, our e-newsletter asked whether you think that the so-called “nocebo” effect adequately explains patients switching away from biosimilars. To view results of the poll, visit The Center for Biosimilars

To read all of these articles and more, visit centerforbiosimilars.com.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of November 20.

The Top 5 Biosimilars Articles for the Week of November 20

 conducted by the Alliance for Safe Biologic Medicines (ASBM) show that Canadian physicians support the use of distinguishable names for biologic therapies, including biosimilars, and that these physicians are open to using biosimilars for non-medical reasons so long as they retain control over the decision to switch a patient’s treatment.

The results of the survey were recently presented at the Drug Information Association Annual Canadian meeting in Ottawa by ASBM's past chairman, Harry Gewanter, MD.

"Distinguishable non-proprietary naming for all biologic medicines is important for the appropriate use of originator biologics and biosimilars, as well as pharmacovigilance," said Gewanter in a 

. "Further, Canadian physicians believe it is critical that the physician-patient relationship remains central when deciding which treatments their patients will utilize."

68% of physicians support Health Canada’s implementation of distinguishable names for biologics, though debate continues over how best to name these products.

54% believe that a biosimilar that shares an international nonproprietary name with its reference product implies that the 2 molecules are identical, which is counter to the principle of biosimilarity.

63% believe that a biosimilar that shares an international nonproprietary name with its reference product implies that the 2 therapies are approved for the same indications, which may or may not be the case, depending upon the drug.

"The results of our survey provide important insight and evidence to regulators and policymakers on the perspectives of Canadian prescribers of biologic medicines," said Michael Reilly, executive director of ASBM. "For originator biologics and biosimilars to be used successfully, decision makers should rely on the input and opinions of those who prescribe them, working collaboratively to develop policies that minimize potential safety or efficacy issues." 

Results of a new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) shows that Canadian physicians support the use of distinguishable names for biologic therapies, including biosimilars,

Survey: Canadian Physicians Support Distinguishable Names for Biologics, Biosimilars

Low levels of competition among drug makers can lead to product shortages and increased generic drug prices, and a recently published 

 suggests that mergers and acquisitions, which reduce the number of players in the pharmaceutical field, should be closely monitored by regulatory authorities.  

The study’s authors assessed data on completed 

 deals from January 1, 1995 to December 31, 2016 in which a generic or biosimilar developer was taken over by an innovator developer. Data on mergers and acquisitions were derived from Bloomberg Finance L.P.

The final study sample consisted of 345 deals, totaling $160.30 billion in value (not adjusted for inflation). In 1995, the total value of such mergers was “negligible,” said the authors, but the value of these transactions grew sharply in 2015 and 2016, reaching an annual value of $44.01 billion in 2016.

“Our results suggest that there is a substantial movement in the last [2] years in the generic sector towards using merger and acquisition deals to grow rather than traditional greenfield investments,” the authors note, saying that, since 2011, 3 mergers were announced at values over $10 billion each.

The paper states that mergers and acquisitions are on the upswing because of the following factors:

Such arrangements allow generics and biosimilars firms to benefit from economies of scale

The loss of major patents has spurred innovators to enter the generic and biosimilars markets

Mergers may allow manufacturers to enter new markets more quickly

Loans are relatively easy to obtain in the healthcare sector

Investors exert pressure to increase value

Companies have concerns about the need to acquire good assets before others obtain them

Vertical integration efforts spur developers to buy parts or sections of the supply chain

Biosimilars create market niches for products with better market exclusivity

These shifts in the competitive landscape signal a change in the economic structures of the generics and biosimilars sector, say the authors. In order to ensure protection against unwarranted price increases or drug shortages, “Antitrust authorities should scrutinize current practices, public drug plans should consider modifying their procurement process to ensure the safety of drug supply, and governments could also explore the possibility of establishing public generic manufacturers,” the authors conclude.

Low levels of competition among drug makers can lead to product shortages and increased generic drug prices, and a recently published study in Global Health suggests that mergers and acquisitions, which reduce the number of players in the pharmaceutical field, should be closely monitored by regulatory authorities.  

Study: Record Number of Pharma Mergers Is Changing the Generics, Biosimilars Landscape

The American College of Rheumatology (ACR) has voiced its approval of CMS’ attempts to lower the cost of drugs under Medicare Part D, but also called on the organization to allow more rheumatologists, including those in small practices, to take part in alternative payment models (APMs).

 that would revise the definition of generic drugs to include biosimilars, which CMS refers to as “follow-on biological products,” solely for the purposes of cost-sharing. “Lower-cost alternatives can improve enrollee incentives to choose follow-on biological products over more expensive reference biological products, and can reduce costs to both Part D and Medicare Advantage,” said ACR.

The organization also praised proposed measures to reduce the price of drugs by requiring pharmacy benefit managers (PBMs) to provide a percentage of manufacturers’ rebates negotiated for a drug covered under Part D in the product’s point-of-sale price. “We applaud CMS for exploring mechanisms to lower drug costs through greater pricing transparency on the part of [PBMs],” said ACR. “We are also encouraged that CMS is taking steps to update guidance regarding discriminatory cost-sharing practices.”

However, ACR raised concerns over CMS’ proposal to allow for mid-year formulary changes for generic drugs, saying that patients must have ample time to prepare for any medication switches that may be necessitated by those changes. The proposed rule would permit Part D sponsors to remove brand-named drugs from formularies and replace them immediately with therapeutically equivalent generics upon FDA approval. (Under the proposed rule, all biosimilars would be treated as brand-name drugs and not as generics for the purposes of transitions or mid-year formulary changes, as no biosimilars have been deemed interchangeable by the FDA.) ACR said, “We believe enrollees should have ample notification on any medication switches.”

ACR is also asking CMS to institute changes that will better allow providers in small practices to participate in 

 (APMs). APMs allow rheumatology practices to comply with the Medicare Access and CHIP Reauthorization Act of 2015 without being subject to the merit-based incentive payment system. However, according to ACR, the financial risk and patient thresholds associated with APMs are too high to allow many practices to participate.

 to CMS, ACR’s president, David I. Daikh, MD, PhD, said, “We strongly suggest to CMS a proposal to lower the threshold for requirements to make 'qualifying participant' in an advanced APMs more achievable for smaller practices. We propose CMS lower the patient count threshold from 20% to 10%, lower the payment threshold from 25% to 15%, and consider delaying or softening the planned year-over-year increases in these thresholds.”

ACR is currently developing its own APM, which it unveiled this month at the organization’s annual meeting in San Diego, California, specific to the treatment of rheumatoid arthritis.

ACR Praises CMS on Part D Proposals, Calls for Changes to APMs

 to become the new home of the European Medicines Agency (EMA). The EMA, currently located in London, United Kingdom, must relocate to an EU member state as a result of the United Kingdom’s withdrawal from the European Union.

On Monday, multiple rounds of voting by European ministers 

 the pool of hopeful cities to Amsterdam and Milan, Italy, but failed to determine a clear winner. 

 reports that European ministers resorted to drawing the name of the winning city from a hat.

Amsterdam’s selection will likely come as welcome news to the agency, which recently reported the 

 of an internal survey that found that 65% or more of the agency’s staff would likely be retained in a move to the Dutch city. EMA had warned European ministers that it could expect to retain less than one-third of its staff if forced to relocate to cities including Athens, Greece; Warsaw, Poland; and Zagreb, Croatia. Amsterdam also earned top marks for meeting many of the EMA’s technical requirements for the facilities it offered to the agency.  

 on the European Commission’s decision, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (ABPI), urged leaders to focus on ensuring a smooth transition that will ensure patient safety and access to medicines.

"Up to now the focus has inevitably been on the future location of the EMA,” he said. “But today's decision marks the moment when attention should switch to how patient safety and effective public health can be maintained during this complex transition and into the future.” He added that ABPI calls on “[The United Kingdom] and the [European Union] to put patients first and acknowledge that securing a comprehensive agreement to cooperate on medicines safety, regulation and supply is an urgent negotiating priority."

Another industry group, the European Federation of Pharmaceutical Industries and Association has also 

 on EU and UK officials to cooperate on a smooth Brexit, having warned that an arrangement that fails to produce a trade deal could interrupt more than 1500 ongoing clinical trials and delay the delivery of millions of patient-ready packages of drugs each month.

The EMA began scaling back its activities in August 2017 in order to 

 for its move, suspending its efforts to develop the European Medicines Web Portal (the agency’s online resource concerning medicines that are marketed in the European Union), contributions to electronic submission projects that will allow for online filing of documents related to medicines authorization, and participation in benchmarking of EU regulatory authorities.

Amsterdam, Netherlands, has won its bid to become the new home of the European Medicines Agency.

Amsterdam Named New Home of European Medicines Agency

Four recent studies investigated the proposed etanercept biosimilars SB4, LBEC0101, CHS-0214, and GP2015.

Infographic: Proposed Etanercept Biosimilars

Hi, I’m Kelly Davio for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars. 

Here are the top 5 biosimilars articles for the week of November 13.

Number 5: Intragovernmental organization The South Centre has released a paper that 

calls on regulatory bodies to approve “biological generics”

Number 4: At the SMi Biosimilars North America 2017 conference, a Mylan executive warned that reference product sponsors may be involved in 

a “whisper campaign” against biosimilars.

Number 3: A recent review identified patient-, disease-, and treatment-related 

factors that may predict response to anti—tumor necrosis factor therapies.

Number 2: Contributor Sonia T. Oskouei breaks down the key facts that biosimilar stakeholders need to know about 

CMS’ recent change in biosimilar reimbursement policy.

Number 1: Two major biosimilar patent litigation cases came to a close in recent days, with the ruling 

upheld in an appellate court, and with Janssen dropping its suit

 against biosimilar developer Samsung Bioepis.

The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of November 13.

The Top 5 Biosimilars Articles for the Week of November 13 

 seeks to encourage the use of lower-cost biosimilars instead of reference biologics under Medicare Part D. The proposed rule would modify the definition of generic drugs—for the purposes of non—low-income-subsidy (LIS) catastrophic and LIS cost-sharing&mdash;to include biosimilar therapies.

CMS reports that it has received numerous requests to redefine generic drugs, noting that advocates have expressed concerns that LIS Medicare enrollees are required to pay higher brand copayments for biosimilars, and that treating biosimilars as branded products for the purpose of LIS cost-sharing creates a disincentive for LIS enrollees (as well as non-LIS enrollees in the catastrophic portion of the benefit) to select lower-cost therapies.  

The proposed rule would revise the definition of generic drug to include “follow-on biological products” for purposes of cost-sharing, which CMS predicts will incentivize enrollees to choose biosimilars and thereby reduce costs to the Part D program.

CMS emphasized that the rule would treat biosimilars as generics solely for cost-sharing purposes: “We want to avoid causing any confusion or misunderstanding that CMS treats follow-on biological products as generic drugs in all situations. We do not believe that would be appropriate because the same FDA requirements for generic drug approval (for example, therapeutic equivalence) do not apply to biosimilar biological products, currently the only available follow-on biological products,” according to the proposed rule. “Accordingly, CMS currently considers biosimilar biological products more like brand-name drugs for purposes of transition or midyear formulary changes because they are not interchangeable.”

Notably, the proposed rule does not include language to address reduced patient cost-sharing in Part D 

 (or the so-called “donut hole”), nor does it include language that would change the requirement for a biosimilar manufacturer to provide a 50% rebate for products while a patient is in the coverage gap.

CMS is also contemplating other changes to help reduce the price of drugs under Part D, including requiring a percentage of manufacturers’ rebates that have been negotiated for a drug covered under Part D to be included in the drug’s point-of-sale price. This change targets the rebates and discounts negotiated between manufacturers pharmacy benefit managers (PBMs) that are not being passed along to Medicare beneficiaries.

Currently, according to the proposed rule, “Part D sponsors are allowed, but generally not required, to apply rebates and other price concessions at the point of sale to lower the price upon which beneficiary cost-sharing is calculated. To date, sponsors have elected to include rebates and other price concessions in the negotiated price at the point-of-sale only very rarely.”

CMS will take comments on the proposed rule until January 16, 2018.

A new CMS proposed rule seeks to encourage the use of lower-cost biosimilars instead of reference biologics under Medicare Part D. The proposed rule would modify the definition of generic drugs&mdash;for the purposes of non–low-income-subsidy (LIS) catastrophic and LIS cost-sharing&mdash;to include biosimilar therapies.

CMS Proposed Rule Would Treat Biosimilars as Generics for Cost-Sharing Purposes

The past week has seen the resolution of 2 high-profile biosimilar patent infringement cases. In the first, a district court’s ruling was upheld, and in the second, a reference drug sponsor agreed to drop its infringement claims—with prejudice&mdash;against a biosimilar developer.  

On Monday, the US Court of Appeals for the federal circuit upheld a district court verdict in 

, in which the court ruled that Apotex did not infringe on Amgen’s patent 8,952,138 (the ‘138 patent), which covers a method of refolding proteins expressed in non-mammalian cells, when it developed its proposed filgrastim and pegfilgrastim biosimilars.

 that, in Amgen’s October appeal before 3 judges, most of the panel’s questions centered on whether patent infringement in Biologics Price Competition and Innovation Act (BPCIA) litigation can be demonstrated by relying on information in an abbreviated Biologics License Application (aBLA), as Amgen had argued, and whether Apotex should have been allowed to rely in court on arguments that the biosimilar developer had not raised in a timely fashion.

In the November ruling, the appellate court affirmed the court’s ruling that Amgen failed to prove direct infringement on its patents by Apotex. The court’s 

 stated that “…it was not Apotex’s burden to prove non-infringement…It was Amgen’s burden to prove that Apotex’s processes would infringe the ‘138 patent.”

Johnson & Johnson division Janssen has voluntarily 

 its patent suit against biosimilar developer Samsung Bioepis in a lawsuit regarding its infliximab biosimilar, Renflexis. Janssen had 

 the suit in May, claiming that Samsung Bioepis had both violated the BPCIA and infringed on 3 patents.

, the district court dismissed the claims concerning the BPCIA as moot. Janssen and Samsung Bioepis continued to litigate US patents 

 (both of which cover chemically defined media) and 

 (which covers the use of a clathrate modifier to promote passage of proteins during nanofiltration).

However, on November 10, the parties filed 

 to dismiss the remaining claims of patent infringement. The dismissal was filed with prejudice with respect to claims and defenses related to cell culture and downstream purification processes; thus, Janssen cannot file a future suit against Samsung Bioepis over these particular claims.

“Janssen’s withdrawal of the lawsuit marks a positive step towards improving patient access to biosimilars in the United States,” Mingi Hyun, a Samsung Bioepis spokesperson, told Reuters.

Samsung Bioepis launched Renflexis, the second FDA approved infliximab biosimilar, in the United States in July 2017.

The past week has seen the resolution of 2 high-profile biosimilar patent infringement cases. In the first, a district court’s ruling was upheld, and in the second, a reference drug sponsor agreed to drop its infringement claims&mdash;with prejudice&mdash;against a biosimilar developer.  