Drugs

Court Dismisses Genentech Biosimilar Suit Against Amgen

A Delaware federal judge has dismissed a Genentech suit filed against Amgen under the Biologics Price Competition and Innovation Act (BPCIA). The suit involves Amgen’s application for a biosimilar version of Genentech’s blockbuster cancer drug Avastin. FDA accepted that application for review 1/4. Under the BPCIA, once an application has been accepted for review, an applicant has 20 days to provide the application and such other information that describes the process or processes used to manufacture the biological product that is the subject of the application to certain designated counsel for the reference product sponsor.

Attorneys Benjamin Jackson and Aron Fischer (Bellknap, Webb & Tyler) write in an online blog post that Amgen gave Genentech a copy of the application but, according to the Genentech suit, failed to provide manufacturing information and unreasonably withheld consent to share its application information with Genentech’s outside scientific consultants.

Facing a 3/24 deadline to provide a list of infringed patents, Genentech asked for a speedy hearing. Amgen asked the court to dismiss the Genentech complaint as barred by Amgen v. Sandoz, which held that the only remedies for an applicant’s failure to provide information pursuant to the BPCIA are those prescribed by the statute, chiefly the right to sue immediately for patent infringement. The attorneys say that Genentech argued that the earlier case was not controlling because it addressed the remedies for an undisputed refusal to follow BPCIA requirements, while Genentech wanted declaratory relief to resolve a dispute as to whether Amgen had followed the law.

In an oral order, the judge dismissed the case pursuant to Amgen v. Sandoz, but said it could be re-filed within 45 days. The attorneys say it’s not known what Genentech’s next move will be.

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