Drugs

Appeals Court Rules Against Amgen in Neupogen Biosimilar Case

Continuing the Amgen-Sandoz debate over provisions of the Biologics Price Competition and Innovation Act (BPCIA), the Federal Circuit Court of Appeals has ruled that state claims against Sandoz sought by Amgen are preempted by federal law. The appeals court heard the case on remand from the Supreme Court, which held on cross-appeals from the two companies that an injunction under federal law is not available to force a biosimilar applicant to disclose its aBLA to the reference product sponsor. The high court also ruled that biosimilar applicants may provide required notice of commercial marketing to the reference product sponsor either before or after FDA licenses its biosimilar.

The appeals court said it agrees with Sandoz that the BPCIA preempts state law claims predicated on an applicant’s failure to comply with the provision dealing with disclosure of its aBLA. It noted that patents are inherently a federal matter and that FDA has exclusive authority to license biosimilars. It also found that Amgen was trying to use California law to impose penalties on Sandoz that are not provided in the BPCIA.

“The preemption analysis here demonstrates that Amgen’s state law claims conflict with the BPCIA and intrude upon a field, biosimilar patent litigation, that Congress reserved for the federal government,” the appeals court concluded.

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

Read more

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