This week, the American Conference Institute held its Ninth Annual Summit on Biosimilars in New York City to discuss the latest developments regarding the Biologics Price Competition and Innovation Act (BPCIA). Below is a summary of some key discussions that took place at the meeting.
Donald Ware of Foley Hoag, one of the co-chairs of the event, opened the conference by noting that this year was a kind of turning point; following years of speculation, the BPCIA and related legislation, litigation, and PTAB proceedings have progressed to the point where real trends and developments could be discussed. At least 24 biosimilar applications have been submitted to the FDA since the enactment of the BPCIA, 11 of which have been approved by the FDA. Three drugs have launched in the United States. In addition, dozens of biosimilar-related cases have been filed in district court and hundreds of IPRs have been filed.
Panelists noted that the nascent biosimilar industry looks different from the generic drug industry for small molecule drugs. For example, traditionally “non-generic” companies have been active in the biosimilar space, with Amgen, Boehringer Ingelheim, and Pfizer among those that are developing biosimilars. Large companies with complementary skills have teamed up to bring biosimilars to market, including Celltrion/Teva and Samsung Bioepis/Merck. These collaborations reflect the increased complexity of developing, manufacturing, and marketing biosimilars in comparison to many small molecule drugs, and many expect such large collaborations to be a hallmark of the biosimilar industry in the future.
Now that three biosimilars have hit the United States market, several panels took a close look at how biosimilars are faring. Although Zarxio®, Sandoz’s biosimilar of Amgen’s Neupogen®, has achieved a healthy ~30% market share since its launch in 2015, some panelists, including Ha Kung Wong of Fitzpatrick Cella Harper & Scinto, theorized this was due to a general market shift from Neupogen® (filgrastim) to Amgen’s second generation biologic Neulasta® (pegfilgrastim). There have been no approved biosimilars of Neulasta®. Pfizer’s Inflectra®, a biosimilar of Janssen’s Remicade®, has only achieved about a 4% market share since its launch in 2016. The panelists discussed Pfizer’s antitrust suit against Janssen, brought in 2017 in the Eastern District of Pennsylvania, and how a ruling in that case could impact the market penetration of other biosimilars.
A number of in-house representatives shared their insights and positions. For example, Laura Sim, Senior Counsel at Amgen, shared recent developments in biosimilar naming conventions around the globe and reiterated Amgen’s position that it wants fully distinguishable non-proprietary names to maintain product quality and patient safety. Kristan Lansbery of Regeneron discussed how there can be differences between different batches of originator biologics because of small manufacturing changes, but that the originator has the benefit of development and testing history to maintain quality attributes within acceptable predetermined ranges. Rachel Moodie, Vice President Intellectual Property, Biosimilars, at Fresenius Kabi SwissBioSim GmbH discussed how many reference product sponsors have filed a slew of new manufacturing patents in recent years, a challenge to biosimilar manufacturers who must set their manufacturing processes early in development and cannot easily “design around” the new patents without changing their final product.
Although the past year has provided several additional data points for understanding how biosimilars will behave in the market, how courts will deal with unique biosimilar issues, and which IPRs initiated by biosimilar manufacturers will be most successful, many questions remain. The largest questions surround interchangeables. Many panelists touched on outstanding interchangeable-related questions, including when the first interchangeable will be approved by the FDA and how the various stakeholders will react. While at least fourteen interchangeable applications have been submitted to the FDA, none have been approved. And although the FDA released draft guidance on interchangeability in January 2017, the FDA has yet to release the final guidance. As of this month, 44 states and Puerto Rico have enacted laws to address interchangeable substitution at the pharmacy, but without approved interchangeables, these laws have not been put into action, and it is unclear whether these state laws are preempted by certain provisions in the BPCIA. It is not also not clear how the FDA will approach naming interchangeables, such as whether their non-proprietary names will receive the same four-letter suffix as the RPS biologic. Perhaps we will have more answers on interchangeables and other biosimilar issues by the 10th Annual Biosimilar Conference in 2019.
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