Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Dive Brief:

• A federal appeals court reaffirmed on Tuesday that biosimilar drugmakers are required to notify brand-name companies of their intent to sell a copy biologic six months before marketing the drug.
• Canadian drugmaker Apotex, which has applied for U.S. approval for a biosimilar version of Amgen’s Neulasta, tried to argue it did not need to provide Amgen with notice of commercial marketing as it had already provided Amgen with manufacturing and patent information.
• The same court previously ruled in a related case pitting Amgen against Novartis’ Sandoz unit, saying biosimilar drugmakers must wait until after receiving approval from the Food and Drug Administration before submitting their marketing notice.

Dive Insight:

Under the Biologics Price Competition and Innovation Act (BPCIA), a biosimilar manufacturer must provide brand-name drugmakers with 180-day notice before selling a copy biologic. Biosimilar makers such as Apotex and Sandoz want to be able to submit this notice 180 days before the FDA decides on approval, thereby enabling them to begin selling immediately after receiving a license.

While the issue at stake may appear a minor technicality, the rulings could set a broader precedent for the growing biosimilar market in the U.S.

In the earlier Amgen v. Sandoz case, the U.S. Court of Appeals for the Federal Circuit sided with Amgen and ruled Sandoz (and other biosimilar companies) must wait until after FDA approval, essentially granting brand-name drugmakers a de-facto six-month extension of market exclusivity.

Biologic drugmakers already have 12 years of market exclusivity and an extra six months would give them more time to prepare legal challenges to a new entrant, not to mention adding another half-years’ worth of protected sales.

Sandoz appealed the decision and the Supreme Court is now considering whether to hear that case

With Tuesday’s ruling in Amgen v. Apotex, the appeals court affirmed its previous ruling and further stipulated that providing notice commercial marketing is mandatory regardless of whether a biosimilar company has submitted manufacturing and patent information in the so-called “patent dance” under the BPCIA.

Apotex unsuccessfully argued it did not need to submit the 180-day notice because it had already informed Amgen by exchanging patent information.