In Amgen-Sandoz SCOTUS case, biosim makers lambaste ruling's 6-month exclusivity gift

In a 49-page Supreme Court brief, the Biosimilars Council argued that a longer exclusivity period might mean fewer biosim candidates.

Ahead of the Supreme Court’s scheduled hearing in the Amgen v. Sandoz “patent dance” case, biosimilar advocates weighed in with an amicus brief, stating that a lower court’s decision would hurt “consumers, insurers and taxpayers” if it’s upheld.

In a 49-page brief (PDF) filed with the Supreme Court, the Biosimilars Council tookissue with the U.S. Federal Circuit’s ruling that would give branded drugmakers an additional six-month reprieve before a biosimilars launch. The ruling held that the six-month notice—required by the law that created a biosimilars approval pathway—can't begin until a biosim wins FDA approval.

In making its argument, the group said Congress didn’t intend to create a 12.5 year exclusivity period for costly biologics as part of that law, the Biologics Price Competition and Innovation Act (BPCIA).


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Last month, the Supreme Court agreed to hear arguments on when, exactly, that six-month waiting period can begin. Amgen has argued it doesn’t start until FDA approval, but biosim makers said that interpretation guarantees branded drugmakers an extra six months of market monopoly. They’d like to be able to give their notification sooner.

“If every biologic is assured an extra six months of exclusivity, that shifts literally billions of dollars from patients, federal programs, and insurance premiums to biologic sponsors,” the Biosimilars Council wrote in a brief.

The Biosimilars Council, a division of the newly renamed Association for Affordable Medicines, also argued that the 12-year exclusivity period for biologics was a “hard-fought compromise” as the BPCIA was negotiated. Proposals from different parties ranged from 5 to 14 years of exclusive market access, and 12 years is already long by other countries’ standards, the brief stated.

The Supreme Court is set to hear oral arguments in the case on April 26.

Billions of dollars are at stake as biologic makers aim to squeeze out as much revenue as possible from their big products, while biosim developers want to see their market pick up in the U.S. Biosims can be 15% to 30% cheaper than the originals.

Several biosims have already rolled out in the U.S., including Sandoz's Zarxio, a biosimilar version of Amgen’s Neupogen, and Inflectra, Pfizer's Remicade biosim. The SCOTUS ruling would affect every future biosimilar launch.

Members of the Biosimilars Council include Mylan, Sandoz and Momenta, all of which are developing a range of biosimilar alternatives to top branded biologic drugs.

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