Being ten years in since the enactment of the BPCIA provides us a great opportunity to take a look back at how things have developed in the world of biosimilar over the years. When we founded the Big Molecule Watch blog nearly five years ago, there was not a single biosimilar yet on the U.S. market and only two pending BPCIA litigations. There seemed to be more questions than answers as to how the biosimilar system would operate. Our very first posts, on May 29, 2015, introduced some of the basic concepts of biosimilarity, highlighted some of the legal uncertainty surrounding the BPCIA’s patent dance and commercial marketing of biosimilars, and summarized the issues and positions on appeal in the pivotal Amgen v. Sandoz filgrastim case that eventually would make it all the way up to the United States Supreme Court.
Over the next five years, we reported numerous biosimilar approvals, launches, litigations, settlements, deals, and other legal, regulatory, corporate, and financial news that impacted the biosimilar system and its participants. Below we review our Top 10 posts over the years (in chronological order):
- Amgen Files IPR Petitions on Two Humira Patents (July 1, 2015): In 2015, Amgen and other biosimilar developers challenged a series of formulation patents in AbbVie’s HUMIRA portfolio. What began as a trickle developed into a deluge, ultimately with 22 IPR petitions filed against a total of 13 patents of AbbVie’s HUMIRA patents. Of these, five petitions ultimately resulted in findings of unpatentability for three adalimumab dosing regimen patent, whereas none of the IPR challenges to AbbVie’s formulation patents prevailed. All the IPR challengers eventually settled with AbbVie.
- FDA Rejects Hospira’s Epogen Biosimilar (Oct. 27, 2015): In 2015, the FDA rejected Hospira’s aBLA for its epoetin alfa biosimilar. It was nearly another three years before Hospira finally gained approval of its biosimilar, RETACRIT, which it launched in the U.S. in late 2018.
- What’s in a Name? A Quick Guide to Biologic Drug Names (Aug. 24, 2016): Still confused by seemingly unpronounceable, multisyllabic biologic molecule names? Read our guide to how biologic drugs are named.
- Approval of Sandoz’s Pegfilgrastim Biosimilar May Be Delayed until at Least 2018 (Oct. 28, 2016): Although Sandoz was one of the first companies to file an aBLA for a biosimilar of NEULASTA (pegfilgrastim), its regulatory approval process faced some hurdles. After a rejection in 2016, Sandoz conducted additional testing that eventually led to the approval and launch of ZIEXTENZO (pegfilgrastim-bmez) in November 2019.
- Amgen: Unlikely to Launch Amjevita® Biosimilar Before 2018 (Oct. 28, 2016): In September 2016, Amgen became the first company to obtain FDA-approval of a biosimilar of AbbVie’s HUMIRA (adalimumab). Engaged in BPCIA litigation, Amgen did not launch its AMJEVITA (adalimumab-atto) biosimilar product, however, and eventually settled with AbbVie to obtain a January 31, 2023 U.S. license date.
- Celltrion and Hospira Have Launched Inflectra® in U.S. (Dec. 8, 2016): Following a victory over Janssen regarding one of two asserted patent in U.S. district court, Celltrion and Hospira revealed in appellate court papers that they had launched their biosimilar of REMICADE (infliximab), the first of its kind in the U.S. Later, Celltrion and Hospira would again prevail in court regarding the other asserted patent.
- New BPCIA Litigaton: AbbVie Sues Boehringer Ingelheim Regarding Proposed Biosimilar to Humira (adalimumab) (Aug. 2, 2017): Almost exactly a year after suing Amgen in August 2016 for seeking FDA-approval to market a biosimilar of HUMIRA in the U.S., AbbVie filed a complaint for patent infringement against Boehringer Ingelheim based on its proposed biosimilar. Although AbbVie settled with Amgen the very next month, in September 2017, and proceeded to settle or enter license agreements with many other adalimumab biosimilar developers, AbbVie and Boehringer Ingelheim engaged in a highly active litigation for nearly two years before finally settling in May 2019.
- Study Concludes That Data Supports Switching from Remicade® to Biosimilar Renflexis® (Oct. 26, 2017): In October 2017, an article reported the results of a clinical study that evaluated the efficacy, safety, and immunogenicity of switching from REMICADE to Samsung Bioepis’s biosimilar, RENFLEXIS, in patients with moderate to severe rheumatoid arthritis. The authors concluded that the efficacy, safety, and immunogenicity profiles were comparable among these three groups during the study period, with no treatment-emergent issues or clinically relevant immunogenicity after switching.
- Filgrastim, Pegfilgrastim Biosimilar Litigation Updates (May 21, 2018): From a litigation standpoint, early 2018 was quite active for filgrastim and pegfilgrastim biosimilars, with newly filed BPCIA litigation, appeals, and dispositive motion briefing in numerous cases.
- Biosimilar-Related Patent Litigation Updates (Jan. 28, 2019): BPCIA litigation and biosimilar-related IPRs kept U.S. court dockets particularly busy in late 2018 and early 2019, with numerous ongoing litigations and appeals. The year 2019 brought a record number of biosimilar case resolutions, either through settlement, judicial decision, or dismissal.