Biosimilar companies will no longer have to wait an additional six months after FDA approval to launch new biosimilars. This is due to a unanimous decision by the US Supreme Court. The case set biologics manufacturer Amgen against Novartis subsidiary and biosimilar manufacturer Sandoz. Both attempted to clarify throughout the case what a biosimilar “patent dance” involves.1
Should biosimilar companies have to wait six months after FDA approval before launch? This was a major question the court discussed during the month of April as Amgen attempted to persuade the court that biosimilars should have to wait contrary to Sandoz’s argument which believed the six months created additional exclusivity.
The final opinion was delivered by Justice Clarence Thomas who said, “An applicant may provide notice of commercial marketing before obtaining a license … Amgen’s contrary arguments are unpersuasive, and its various policy arguments cannot overcome the statute’s plain language.”2
The global head of biopharmaceuticals at Sandoz, Carol Lynch believes that this ruling will improve many lives, “The Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments. We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward.”1
The court also discussed the phrase “mandatory patent dance”. The Supreme Court ruled that states will decide whether a biosimilar applicant must provide the biologic reference product sponsor with its application and manufacturing information.. The opinion stated “There is no dispute about how the federal scheme actually works, and thus nothing for us to decide as a matter of federal law. The mandatory or conditional nature of the BPCIA’s [Biologics Price Competition and Innovation Act, which established the pathway by which biosimilars are approved] requirements matter only for purposes of California’s unfair competition law, which penalizes ‘unlawful’ conduct.”2
The opinion may lead to more FDA involvement with the patent dance and interpreting the BPCIA further. Legal battles stand as one of several obstacles facing biosimilar developers. Pearl Pathways employs a team of experts with decades of experience across all life science industries. The biosimilars industry is still in its infancy in the U.S. marketplace, and we are equipped to help guide your product to market. Contact us today to start a conversation.
2 https://www.supremecourt.gov/opinions/16pdf/15-1039_1b8e.pdf