Much of the future of the biosimilar industry could now rest on a single upcoming review, after the Supreme Court declined to hear an appeal from Apotex over a ruling in Apotex, Inc. v. Amgen, Inc. (U.S., No. 16-332, 12/12/16.) While the decision of the Supreme Court to deny the appeal without an opinion is nonetheless a heavy blow to the biosimilar market, attention has now shifted towards a different appeal over a biosimilar case, namely Sandoz, Inc. v. Amgen, Inc.
Crucially for the industry, the Sandoz case appears to have attracted the support of the Solicitor General of the United States. The Solicitor General has advised the Supreme Court to review the case, while also disagreeing with the interpretation of the Biologics Price Competition and Innovation Act.
The Supreme Court determined in Sandoz, Inc. v. Amgen, Inc. that biosimilars, near-copies of existing biologics, must wait for a six-month period between the drugs appearing on the market and winning federal approval. Both Sandoz and Apotex have disputed the interpretation of the BPCIA, and if the Supreme Court decides to hear the appeal and sides with the Solicitor General, it will mean that biosimilars will be able to enter the market much sooner than at present.
The case is highly important for the future of the industry, as biosimilars are expected to be both significantly cheaper to produce and less expensive for consumers. With biologics already used to treat a range of diseases such as cancer, a breakthrough for the biosimilar market could start a significant downward trend for some of the most expensive drugs on the market and break many patent strangleholds.
With the route for earlier availability of biosimilars still open in the Sandoz case, that looks a step closer to reality. Indeed, there has been some speculation that the Apotex case was denied its appeal while the Supreme Court prepares for Sandoz, since both are so similar. Whatever happens, it now seems certain that Sandoz will be crucial to the industry, regardless of the Supreme Court’s decision.
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