Biologics

Government Wants SCOTUS Biosim Provision Review

The U.S. acting solicitor general is recommending that the Supreme Court hear appeals by Amgen and Sandoz on the implementation of portions of the Biologics Price Competition and Innovation Act (BPCIA). In an amicus brief, the acting solicitor general says that a Federal Circuit Court of Appeals conclusion that an applicant may provide the 180-day advance notice of first commercial marketing of its biosimilar only after FDA has licensed the biosimilar, and that a court may enforce a section of the law by enjoining the applicant from such marketing until 180 days after the applicant provides that notice was incorrect. That ruling was appealed by Amgen.

Sandoz challenged the court’s determination that where an applicant fails at the outset to provide the sponsor with its aBLA and manufacturing process information, the sponsor’s only recourse under the law is to bring an immediate patent suit. The acting solicitor general says the appeals court got it right in that part of its ruling.

“The proper interpretation of those provisions has a significant impact on the operation of the BPCIA and the ability of aBLA applicants promptly to bring their biosimilars to the public,” the brief says. “And because the provisions are integrally related, the court should consider all of the questions presented together.”

Observers say that the acting solicitor general’s recommendation that the high court hear the appeal is a very strong signal that the court is likely to do so. They say the case is expected to be briefed in early 2017, argued in April, and decided 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