Drugs

Amgen, Sandoz Argue Biosim Issues at Supreme Court

In more than an hour of oral arguments 4/26, representatives of Amgen and Sandoz highlighted their differing interpretations of the requirements in the Biologics Price Competition and Innovation Act before the Supreme Court. Media accounts indicate that the principal issues argued included whether FDA can approve a biosimilar before a 12-year exclusivity period expires, whether it would be possible for a reference product sponsor to file a complaint in good faith before FDA confirms the parameters of a final product licensure, and what is considered a violation of the “patent dance” and information disclosure provisions, and how state law requirements affect the outcome of those provisions.

Amgen, which makes the reference product Neupogen, argued that the notice to market a biosimilar can’t start until FDA approval. However, Sandoz, which will produce a biosimilar called Zarxio, said that such an interpretation would mean an additional six months of exclusivity for the reference product that Congress didn’t intent to provide.

Several of the justices appeared to side with Amgen, the Associated Press reports. “We are being asked to interpret very technical provisions that I find somewhat ambiguous and I’m operating in a field I know nothing about,” said Justice Stephen Breyer. “But it’s going to have huge implications for the future.”

Justice Anthony Kennedy said it seemed that time has to start running from the date a biosimilar is licensed. And Chief Justice John Roberts said the original drug maker would have difficulty bringing a patent infringement case without knowing the biosimilar’s specifics.

Court watchers say a ruling is expected by the end of June.

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