On May 1, Amgen filed a lawsuit in District Court against Sandoz and its former parent Novartis regarding patents on denosumab, sold under the Prolia® and Xgeva® brand names. The fact that the lawsuit was filed is not surprising, as BPCIA suits have been routinely filed in the past in an effort by reference manufacturers to delay commercialization of a biosimilar competitor. It is interesting to note, however, the number of newer biosimilar pipeline drugs that are nearing commercialization and the relative paucity of suits.
We reported in December 2022 on a suit by Janssen against Amgen over alleged Stelara® patent violations by the latter, and on Biogen’s BPCIA patent litigation against Sandoz regarding Tysabri® patents. In the case of Tysabri, Biogen has 32 major patents listed in the Purple Book, the last of which is set to expire in 2036 and the earliest patent expiration date is June 2024. Yet, the main composition of matter patents have already expired. The less-critical method-of-treatment patents remain.
We turned to our trusted legal resource, Kevin Nelson, Esq, Partner and Intellectual Property Attorney at ArentFox Schiff Law. He pointed out that there were more active suits recently, but in most cases, the parties have settled. “Settlements of both existing and pipeline biosimilar products have meant less activity,” he told us via Email. “We were seeing an uptick in biosimilar litigation and regulatory proceedings, but a number of those matters settled, and many pipeline products are the subject of settlements. The settlement landscape as a whole as ‘cleared the decks’ a bit in the short term with respect to near-term pipeline products.”
Mr. Nelson emphasized another reason for the relative lack of litigation activity—and it has less to do with patents or the science than with the business case for biosimilars. “Biosimilar manufacturers are concerned about the payment and reimbursement of biosimilars,” he said. “Most biologics are reimbursed under Medicare Part B, and under that scheme there is more of an incentive to administer a higher-cost product, which is the established biologic and not the biosimilar.”
The prospects for biosimilars may also play a role. For example, current pharmacy benefit manager coverage policies are leaning towards parity coverage for Humira® and adalimumab biosimilars; this does not provide any incentive for switching to adalimumab biosimilars. As a result, biosimilar uptake will be primarily reliant on patients who have not already received Humira.
The real or imagined implications of new legislative or regulatory policies may have some prospective biosimilar makers reconsidering their commercialization plans. “Manufacturers are unsure of what the exact impact of the Inflation Reduction Act will be on the payment for biosimilars,” said Mr. Nelson. “The Act purportedly seeks to keep the costs of biologic and biosimilar costs down and ensure high reimbursement payments, but many are skeptical and even believe prices will increase.”
The result could be fewer new biosimilar development programs. “If we dig a bit deeper,” he commented, “you will see that the competition is still coming primarily from the same sources. With denosumab, for example, the most recent suit was against Novartis/Sandoz. These are companies for the most part that can compete in light of the challenges that I mentioned.”
To clarify, according to the FDA‘s Center for Drug Evaluation and Research, 104 biosimilar development programs were in process as of first quarter of 2023. This has been growing steadily, but the agency has remained steadfast in the confidentiality of the participants. We do not know how many of these involve biologics without present competition or additional competitors for previously approved biosimilars.
In other words, fewer biosimilar development programs could mean fewer opportunities for BPCIA patent litigation. The latter might seem like a good thing, but not at the expense of the former.