Drugs

Amgen Sees ‘Chaos’ in Biosimilars if Sandoz Prevails

Amgen’s Supreme Court opening and response brief in Sandoz v. Amgen cautions that there will be “chaos” in the biosimilar world if the court rules against Amgen’s positions on the Biologics Price Competition and Innovation Act’s (BPCIA) 180-day notice of biosimilar marketing and patent dance provisions. Attorney Sara Koblitz (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that Amgen’s brief does not raise any new arguments since the issues have been extensively litigated in lower courts.

It’s Amgen’s position that companies must participate in the patent dance if the BPCIA is to have its intended effect. And it says that 180-day notice of marketing can only come after FDA licensure to ensure time to efficiently enforce patents. Koblitz says Amgen reasons that the proper result is obvious, as it both reflects the law’s text and structure and it better promotes the law’s purpose.

“Amgen argues that Sandoz’ interpretation of the BPCIA would require reference product sponsors to sue on every conceivable relevant patent in order to protect its patent rights,” Koblitz concludes. “Without exchange of product information, the reference product sponsor has no way of knowing which patent is implicated. And if an applicant could choose not to provide required disclosures and refuse to provide 180 days’ notice of commercial marketing, the sponsor could only enforce its patent rights through emergency injunctive relief after licensure. Couched in its chaos theory, Amgen argues that Sandoz’ interpretation would negate the ‘process’ that the BPCIA was intended to introduce. Instead, Amgen believes that reference product sponsors will just have to close their eyes and sue without any knowledge of actual infringement.”

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