For years, reference drug manufacturers have tried to extend the exclusivity periods for their products with patent mazes, lifecycle management tools, and long legal battles resulting in marketing settlements. Etanercept has been the poster child for inexplicable delays in biosimilar competition in the US. With a potential launch date of 2029, Enbrel will have had 30 years of market exclusivity. According to its 2024 earnings report, Amgen’s US revenues for Enbrel have been $3.29 billion (and a 10% decrease globally from that reported in 2023).
Only two companies have been approved to market etanercept biosimilars—Sandoz with Erelzi and Samsung Bioepis with Eticovo, which were approved in 2016 and 2019, respectively. No other biosimilar manufacturer has sought FDA approval since then. Fortunately, Enbrel has several effective biologic therapeutic alternatives for each of its immunologic indications. However, it would be easy to believe that the biosimilar manufacturers see a closing window of opportunity in the face of other TNF inhibitor approvals and new interleukin biosimilar introductions.
It is heartening to read about Sandoz’s lawsuit filed in mid-April against Amgen in an attempt to unblock their path to commercialization. Sandoz’s antitrust lawsuit seeks to prevent Amgen from “using certain patent rights to block biosimilar competition and allow Sandoz to launch Erelzi as soon as possible.” In its press release, Sandoz is seeking damages which could be subject to tripling under anticompetitive statutes. The lawsuit was filed in the US District Court for the Eastern District of Virginia.
Of course, it seems that this action could have been taken in 2016 when the biosimilar was first approved. It is possible that Novartis, Sandoz’s parent company at the time, would not entertain such a legal action as it was a reference product manufacturer in its own right. Since the spin-off of Sandoz into an independent company in 2023, the view inside the boardroom may have changed. This is purely speculation. When asked by BR&R for comment on this question, Sandoz would not respond. Perhaps this is a case of better late than never, and hopefully it will shave at least a couple of years off the wait for an etanercept biosimilar launch.
Sandoz launched Erelzi in Europe in 2017.
