Biosimilars Council urges SCOTUS to limit biologics exclusivity period

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), has filed a brief in support of Sandoz’s petition for certiorari in the pending Sandoz v Amgen case.

In the brief, filed on Friday, February 17 at the US Supreme Court, the council argued that the Federal Circuit was wrong to give biologic manufacturers an additional six months’ marketing exclusivity beyond the 12 years the Biologics Price Competition and Innovation Act (BPCIA) provides.

The Federal Circuit said in July 2015 that the ‘patent dance’ exchange is optional under provisions set out in the BPCIA.

However, the court added that a biosimilar applicant must give 180 days’ pre-marketing notice after an application has been approved by the US Food and Drug Administration.

Trade organisation the AAM was previously known as the Generic Pharmaceutical Association.

The council argued that the average daily cost of a biologic is more than 22 times than that of a traditional pharmaceutical, and that this had urged Congress to pass the BPCIA back in 2010.

It added that there is “the need for an abbreviated approval pathway to bring relief to patients, insurers, and government insurance programmes and to address the healthcare cost crisis”.

In the brief, the council said: “The longer the exclusivity period granted to biologic sponsors, the longer before consumers, insurers, and the government could access the much-needed savings offered by a biosimilar pathway.

“The duration of that exclusivity period therefore was critically important.”

The AAM said in a statement: “AAM urges the Supreme Court to recognise the importance of biosimilar medicines in promoting patient access to affordable healthcare, by overturning this unintended windfall for brand name biologic manufacturers.”