Drugs

Biosimilar Case Appeal Likely Off Until October

By asking for the view of the Solicitor General on an appeal filed by both parties in the Amgen v. Sandoz biosimilar case, the Supreme Court has effectively delayed any decision on the appeal until at least October, once its new session opens. Three Fish & Richardson attorneys who have been tracking the case write in an online blog post that the high court invites the Solicitor General to outline the government’s view on an issue about 11 times a year. It takes the Solicitor General, on average, between four and five months to respond to the request, they say.

The case arose after Sandoz filed an aBLA for Zarxio, a biosimilar of Amgen’s Neupogen filgrastim product. The Federal Circuit Court of Appeals held that (1) the “patent dance” provisions of the Biologic Price Competition and Innovation Act (BPCIA) are not mandatory for some applicants; and (2) a biosimilar applicant may not give effective notice of intent to commercially market until after FDA has licensed the applicant’s biosimilar product.

Sandoz’ appeal to the high court asks for a review of the second part of the decision, arguing that the Federal Circuit “has disrupted the careful balance struck by Congress between competition and innovation” by “delaying access by patients to biosimilars for six months longer than Congress intended.” Amgen filed an opposition to Sandoz’ request for the high court to hear the case and also filed a conditional cross-appeal saying that if the court does decide to hear the case, it should also review the “patent dance” aspect.

The attorneys write that for now the Federal Circuit’s holdings remain binding. “For co-pending late-stage BPCIA litigation,” they say, “this means that the courts will be forced to build upon an uncertain foundation.” They note that if the Federal Circuit rules in a pending Amgen v. Apotex case involving a Neulasta biosimilar that notice of commercial marketing is only effective after FDA approval for subsection (k) applicants who choose to engage in the “patent dance,” based on its ruling in Amgen v. Sandoz, only to have that decision overturned by the Supreme Court, there are likely to be requests for the high court to hear the Apotex case as well.

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