Drugs

Sandoz Asks High Court Biosimilars Review

Sandoz is asking the Supreme Court to decide whether the 180-day notice of commercial marketing required by the Biologics Price Competition and Innovation Act (BPCIA) of 2009 can only be given after a proposed biosimilar product receives FDA approval. The company is appealing a Federal Circuit Court of Appeals split decision that held that the 180-day notice can only be given after FDA approval.

The Sandoz filing says the appeals court decision “turned this mere notice provision into a grant of 180 days of additional exclusivity for all biological products beyond the exclusivity period Congress expressly provided, delaying the launch of all future biosimilars by six months.” It argues that the decision transformed the notice provision into a standalone requirement unconnected to the BPCIA patent resolution provisions and disregarded the right provided by Congress to initiate patent litigation.

“The Federal Circuit’s decision cannot be squared with the BPCIA’s text and purpose, and it conflicts with this court’s precedents,” Sandoz says. “By its plain terms, the notice of commercial marketing provision simply calls for 180 days’ notice before a biosimilar is marketed. Regardless of whether notice is given before or after FDA approval of the biosimilar, the notice would serve the statute’s purpose of giving the reference product sponsor at least 180 days to initiate suit. But special notice after FDA approval would be superfluous, as FDA licensure is a public act.”

Although Amgen brought patent litigation, Sandoz says, it did not seek an injunction based on any alleged patent infringement. “Without any such patent showing by Amgen,” it concludes, “the plain terms of the BPCIA authorized Sandoz to make its biosimilar filgrastim product Zarxio immediately available to cancer patients.” It says that Sandoz already had provided Amgen more than 180 days’ notice of its intent to market, and any statutory exclusivity period had expired since Amgen had already had 24 years of exclusivity.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome