Life Sciences Stakeholders Counting Down to Supreme Court’s Clarification of Biosimilar Statute


Many voices are chiming in during the countdown to oral arguments in a high profile Supreme Court biosimilar case being watched by biopharmaceutical industry stakeholders.

The Supreme Court is receiving briefs from the parties and friends of the court in Amgen v. Sandoz, a case in which the high court is expected to clarify how and when biosimilars may be approved and sold in the U.S. The court will hear oral arguments in this case April 26—Bloomberg BNA will be there—and a decision is expected in June.

The court is reviewing a decision by the U.S. Court of Appeals for the Federal Circuit interpreting the Biologic Price Competition and Innovation Act (BPCIA). The statute creates an abbreviated approval pathway for biosimilars—highly similar versions of FDA-approved biologics. The biosimilars are expected to be priced 15 percent to 30 percent less than the original biologic. Considering some biologics cost $80,000 a year or more, that’s a lot of money saved.

The statute includes provisions for the biosimilar applicant and the owner of the biologic patent to exchange information to facilitate the decision by the patent owner as to whether or not the biosimilar is infringing its patent. The parties have different interpretations of the statute, and Sandoz has told the Supreme Court that one result of the Federal Circuit’s ruling is that all biosimilars will be delayed from going on the market for six months.

On the road to the Supreme Court’s decision in June, nine friends of the court briefs were submitted to the court in support of Sandoz’s position, including one by the U.S. government. To date, five briefs have been submitted in support of Amgen, which argues that the statute has a mechanism to protect the rights of the patent holders for the original biologics and that Sandoz’s position will weaken that mechanism.

One of the briefs came from AbbVie Inc., which is in a unique position to comment on the dispute. Like Amgen, it is the owner of an original biologic for which a biosimilar has been approved by the FDA. AbbVie owns the patents covering Humira (adalimumab), which treats rheumatoid arthritis, psoriasis and Crohn’s Disease. AbbVie also is suing Amgen, the maker of Amjevita, a biosimilar of AbbVie’s Humira, contending the Amgen biosimilar infringes its patents. I wrote about AbbVie’s brief and the story is here.

On other fronts, stakeholders have been talking about the law as currently interpreted by the Federal Circuit and as administered by the FDA. I covered a panel discussion in which an attorney who had worked for the FDA suggested that resolution of biosimilar regulation issues hasn’t been as slow as people think. That article is here.

Suffice it to say, a lot is happening in the white hot biosimilar area, and Bloomberg BNA will continue to keep you abreast of all of the most important developments.

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