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Opinion: The Year Ahead in Biosimilar Potential


Many firsts may be in store for the biosimilar industry in 2021, although it will be dogged by ongoing difficulties, Center for Biosimilars® Advisory Board members said.

Many exciting biosimilar developments could be just around the corner in 2021, according to members of The Center for Biosimilars® Advisory Board, a panel of experts from across the clinical, business, academic, pharmacy, legal, and manufacturing spectra. The potential for the first interchangeable biosimilar designation, a fresh drug classification in ophthalmology for biosimilars, and the first official insulin biosimilar are among these potential advances, they said.

However, they said there are still many hurdles to cross to get biosimilars into the mainstream of health care in the United States and beyond. “There continue to be themes of persistent barriers to biosimilar adoption in the United States, including the payer landscape, operational challenges, knowledge gaps, and clinical hesitancy with regard to switching patients from reference biologics to biosimilars, or between biosimilars,” said Advisory Board Member Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars for Cardinal Health.

“The payer landscape remains one of the most-cited challenges for biosimilar adoption. Payer policies can vary by plan, region, and even time of year,” and these policy variations can complicate the job of inventory management in practices and health care institutions that may be required to stock multiple brands of a single biologic to satisfy requirements of multiple payers, she said. The difficulty increases as more biosimilars appear on market, making it necessary for providers to “decipher the economic, operational, and clinical impact of choosing one product over another."

The First Interchangeable?

The potential for the first interchangeable designation for a biosimilar would be a “significant milestone” for the United States, where FDA interchangeable guidance—substituting biosimilars for reference products at the prescription counter—still has not resulted in a single interchangeable approval, she said.

“The implications of interchangeability designation on various stakeholders such as payers, pharmacy benefit managers, providers, and pharmacies are yet to be known,” although there is great potential value in interchangeability for making insulin products more widely available at lower cost, Oskouei said.

In November 2020, Samsung Bioepis and Biogen announced that the FDA had accepted their application for a ranibizumab biosimilar (SB11) for the treatment of patients with retinal vascular disorders. This would constitute a new drug category for which biosimilars are available, and advisory board members this year lamented the narrow range of available biosimilars (covering just 9 reference products). “With a very dynamic market, which includes emerging treatment options and step-therapy payer strategies, biosimilars can potentially have a significant impact on the overall ophthalmology treatment landscape,” Oskouei said.

The year 2021 may bring the first “authorized biologics” to market. These would be cheaper versions of reference products produced by innovator companies to compete with biosimilars. Originator companies so far have tended to rely on lowering the prices of their brand biologics to prevent the loss of business from biosimilars, notes Advisory Board Member Ha Kung Wong, an intellectual property attorney and partner with Venable.

“The idea in the small molecule space was to maintain pricing on the brand while using the ‘authorized generic’ to increase patient access and compete with generics made by competitors,” he said. “That still seems viable in the biologics space, but perhaps the resource requirements are somewhat prohibitive. Or it could be the fact that they’d need to gain interchangeable status to be truly an authorized generic equivalent, so perhaps as we gain more insight into acquiring that designation, we’ll see biologic companies employ this strategy.”

Currently in front of the Supreme Court is a case that could influence future and preexisting biosimilar approvals, Wong noted. Arthrex v Smith & Nephew involves a dispute whether administrative patent judges of the Patent Trial and Appeal Board (PTAB) should be appointed directly by the president of the United States or by lesser officials, which has been the norm. The case has a bearing on PTAB decisions regarding post grant reviews (PGR) and inter partes reviews (IPRs), which weigh the patentability of biologics and other products. “It’s going to be briefed and argued in front of the Supreme Court in 2021 and has potential to reverse a good number of previously decided IPRs and PGRs, if not disrupt the system entirely,” Wong said.

“We’re currently assuming that, like in oil states, the Supreme Court will find a way to not upset what has already been done and just fix the issue of PTAB judges prospectively instead of retrospectively,” he said. “But if they don’t, this could significantly impact the biologics industry, particularly in light of the increase in PGR filings that allow Section 101 (35 US Code, patentability) challenges of biologics and diagnostic-based patents.”

Unless they are available for use and actually employed, biosimilars are veritable wallflowers that serve no purpose, notes Advisory Board Member Brian Lehman, MBA, MHA, RPh, director of Strategic Alliances and Patient Advocacy at Sandoz. “In 2021, I’m hopeful we’ll see growing support for policies that improve patient access to these high-quality medicines, including reducing out-of-pocket costs for biosimilars under Medicare Parts B and D when patients use a lower-cost biosimilar.” This includes the removal of prior authorization requirements for biosimilars in cases where prior authorization has already been granted for the reference biologic, he said.

Lehman anticipates biosimilar markets will continue to build on existing gains. “I’m energized by the growing progress we’ve seen for the biosimilar market in 2020. I’m optimistic this will continue into 2021 and we’ll see more patients gain access to these more affordable biologic treatments.”

Legislative Solutions

Advisory Board Member Imron T. Aly, co-leader of Schiff Hardin's Intellectual Property Group and co-chair of the firm's Hatch-Waxman and Biosimilars patent litigation team, expressed confidence that bills wending their way through the legislature would contribute to biosimilar uptake. “Recent examples expected to gather traction would reduce or eliminate co-pays, give the Federal Trade Commission more antitrust power for patent thickets, and encourage Medicare coverage of biosimilars,” he said.

Further, Aly expects biosimilar sponsors and advocates to more strongly oppose anticompetitive tactics used by originator companies. “We expect more court actions, as patent landscape analysis over the past few years should finally translate into more litigations on both patent and antitrust-type claims,” he said.

In 2020, the FDA issued much fresh guidance in both final and draft form, most of which should be considered insubstantial, according to Advisory Board Member Sarfaraz K. Niazi, PhD, an adjunct professor of pharmaceutical science at the University of Illinois, although Aly predicted that something might come from this.

  • Final guidance was issued on user fee rates for biosimilar sponsors seeking to have their biosimilar applications reviewed by the FDA.
  • Draft guidance was issued on promotional labeling and advertising considerations for biosimilars and reference products.
  • Draft guidance was issued on interchangeability for biosimilars and licensing conditions.

“We expect more FDA movement, related to their recent question and answer guidance, both about obtaining approval and about the elusive interchangeability designation,” Aly said.

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