June 12, 2017
Apobiologix Applauds Supreme Court Decision in Sandoz Biosimilar CaseSupreme Court decides 180-day notice may be given prior to FDA approval
Toronto, ON – Apobiologix, a division of the Apotex Group focused on biologics innovation, today announced their support of the Supreme Court decision in the Sandoz v Amgen case. The case clarifies the timing of the Biologics Price Competition and Innovation Act (BPCIA) requiring biosimilar companies to provide 180-days notice to the companies of the reference products of intent to market the biosimilar. Based on the new ruling, this notice may now be given prior to FDA approval.
Earlier interpretations of BPCIA required that the 180-day notice be given after FDA-approval.
"This ruling is of critical importance, as it will allow biosimilars to reach patients and physicians sooner." said Steve Lydeamore, president, Apobiologix.
The Supreme Court invited the parent company of Apobiologix to submit this briefing, based on the company's earlier submission of a Petitionfor Certiorari, which was denied in December. The Petition for Certiorari filed by the company questioned appropriate timing for the currently-required 180-days' notice to brand companies from biosimilar companies who have followed the patent dance. The patent dance is a formal procedure with strict timing and sequencing requirements for resolving patent disputes between the biosimilar company and the company marketing the reference product.
In today's ruling, the Supreme Court has allowed the timing of the 180-days' notice for companies to come before regardless of if they had participated in the "patent dance" or not.
Biosimilar medicines are biologic therapies developed to offer patients additional treatment options with similar therapeutic value to existing products. Biosimilars are required by the FDA to demonstrate that there are no clinically meaningful differences in terms of the safety, purity, and potency between the biosimilar product and the previously licensed biologic drug.
Apobiologix is a leader in the field of biosimilar development. As a division of ApoPharma USA, Inc. which is part of the Apotex group of companies, Apobiologix is focused on developing innovative biologic products, aimed at providing patients and providers with high-quality medicines. For more information about Apobiologix, go to www.apobiologix.com.