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FDA opens abbreviated approval pathway for interchangeable biosimilars
The FDA has proposed a regulatory path for biosimilar biologics that are interchangeable with the reference product.
The U.S. Supreme Court has ruled that biosimilar companies can take their versions of biological drugs to the market 6 months sooner in a precedential ruling that could mean quicker access to less expensive medications.
The unanimous ruling overturns an appeals court ruling in favor California-based Amgen that had barred competitor Sandoz from selling its biosimilar of Neupogen (filgrastim) until 6 months after Food and Drug Administration approval. Justices held that the Biologics Price Competition and Innovation Act of 2009 (BPCIA) allows biosimilar applicants to provide notice of commercial marketing prior to obtaining licensure by the FDA.
Carol Lynch, global head of Biopharmaceuticals at Sandoz, said the ruling helps to eliminate unnecessary barriers so that patients can access more affordable medicine in a more timely manner.
“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,” Ms. Lynch 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
Supreme Court
In a statement, an Amgen spokeswoman said the company was “disappointed in the court’s decision on the notice of commercial marketing,” but that it will “continue to seek to enforce our intellectual property against those parties that infringe upon our rights.”
The “patent dance” referred to by Ms. Lynch is the often lengthy process by which companies marketing brand name and biosimilar medications spar and undergo legal proceedings before the biosimilar can enter the market.
In this case, Sandoz filed an application with the FDA in May 2014 seeking approval to market Zarxio (filgrastim-sndz) Neupogen as the reference product. Amgen has marketed Neupogen since 1991 and holds patents on methods of manufacturing and using filgrastim. In July 2014, the FDA accepted Sandoz’ application for review. In October 2014, Amgen sued for patent infringement, alleging that Sandoz failed to adhere to the BPCIA by unlawfully providing its notice of commercial marketing before FDA licensure, among other arguments.
The U.S. Court of Appeals for the Federal Circuit in Washington ruled in favor of Amgen, holding that Sandoz must wait for an FDA license before marketing its biosimilar, which meant another 6-month waiting period. The Supreme Court disagreed. Justices based their decision on the plain language of the BPCIA, ruling that the statute allows for applicants to provide marketing notice either before or after receiving FDA approval.
In a statement, the Pharmaceutical Care Management Association said the Supreme Court’s ruling on biosimilars will help create more competition among costly biologic medications, “which is the key to reducing overall prescription drug costs for consumers, employers, government programs, and others.”
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