The Supreme Court issued a unanimous ruling today that will accelerate the pace at which biosimilars can be made available to the public.
The court ruled biosimilar manufacturers do not need to wait an extra 6 months after FDA approval to market their agents, provided the standard exclusivity period for the biosimilar’s reference product has expired.
The high court’s ruling settles a dispute between Amgen — a biologics manufacturer — and Sandoz, a division of Novartis that develops biosimilars.
Federal legislation enacted in 2010 allows manufacturers of biosimilars — less expensive generic versions of biologics that are made from living cells instead of chemicals — to begin marketing their products after a 12-year period of exclusivity for the biosimilar’s reference product.
In 2015, the FDA approved filgrastim-sndz (Zarxio, Sandoz), making it the first biosimilar product to receive regulatory approval in the United States.
Filgrastim-sndz is designed primarily to decrease incidence of infection — manifested by febrile neutropenia — among patients with nonmyeloid malignancies who also receive myelosuppressive anticancer drugs.
The FDA approved filgrastim-sndz for the same five indications as its reference product, filgrastim (Neupogen, Amgen).
Amgen filed a patent-infringement lawsuit that claimed Sandoz violated a provision of the Biologics Price Competition and Innovation Act that requires biosimilar manufacturers to provide a 6-month “notice of sales” to the reference product manufacturer.
A federal appeals court ruled in favor of Amgen, declaring that the 6-month notice of sales cannot begin until after the biosimilar manufacturer receives regulatory approval for its product.
Sandoz — which contended that interpretation essentially provides an extra 6 months of exclusivity to the reference product manufacturer — appealed to the Supreme Court.
Justice Clarence Thomas delivered the high court’s opinion, in which he wrote that Amgen’s “unpersuasive” arguments “cannot overcome the statute’s plain language.”
“The statute’s use of the word ‘licensed’ merely reflects the fact that, on the ‘date of the first commercial marketing,’ the product must be ‘licensed,’” the opinion read. “Accordingly, the applicant may provide notice either before or after receiving FDA approval.”
Sandoz launched filgrastim-sndz in fall 2015 at a list price of 15% less than that of filgrastim. As a result, filgrastim sales dropped from more than $1 billion in 2015 to $765 million last year, Amgen said in regulatory filings.
“Biosimilars offer significant value to patients, providers and payers, increasing the number of treatment options available to patients across many disease areas at a reduced cost to the health care system,” Carol Lynch, global head of biopharmaceuticals for Sandoz, said in a statement. “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.
“As the global leader in biosimilars, it is our responsibility to help eliminate barriers so patients can access more affordable medicine,” Lynch added. “The results of this Supreme Court case reinforce that the work we are doing every day has meaning to the patients and customers we are here to help.”
Amgen has not yet responded to HemOnc Today’s request for comment. – by Kristie L. Kahl