Boehringer Ingelheim today announced that its adalimumab biosimilar (biosimilar to Humira) has been accepted for regulatory review by the FDA and the EMA (European Medicines Agency). This is the second biosimilar candidate to Humira that FDA has accepted for regulatory review. The first, Amgen’s application for its Amjevita (adalimumab-atto) biosimilar…
FDA has denied AbbVie’s Citizen Petition on interchangeability. Back in December 2015, AbbVie submitted a Citizen Petition to FDA requesting that the agency take certain actions regarding interchangeability standards for biosimilar applicants. Specifically, AbbVie requested that FDA: (1) “ensure that applicants seeking interchangeability determinations meet the ‘Safety Standards for Determining Interchangeability’…
Today, the FDA announced the availability of a draft guidance on biosimilar interchangeability, entitled “Considerations in Demonstrating Interchangeability With a Reference Product,” which is currently available on FDA’s website. The official announcement is scheduled to be published in the Federal Register tomorrow, January 18, 2017. This guidance provides an overview…
The Supreme Court has granted Sandoz’s petition for certiorari, and Amgen’s cross-petition for certiorari in Amgen v. Sandoz. The Order is excerpted below and can be found here: 15-1039 SANDOZ INC. V. AMGEN INC., ET AL. 15-1195 AMGEN INC., ET AL. V. SANDOZ INC. The motion of Apotex, Inc., et…
FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.” The guidance provides that naming for originator biological products, related biological products, and biosimilars should include a “core name” followed by a four-letter suffix. The core name typically will be the USAN Council name for the Reference Product (RP)….
On January 4, 2017, the Federal Circuit granted a motion for en banc rehearing in Wi-Fi One LLC v. Broadcom Corp., No. 2015-1944. In the original Wi-Fi One decision, the court held that, due to binding precedent, it could not review the PTAB’s decision to institute IPR over the Patent Owner’s assertions that the petition…
Law360 has published an article by contributing editors here at Big Molecule Watch. The article, titled “IPR Estoppel Takes Shape,” looks at recent cases that discuss the scope of estoppel stemming from inter partes review proceedings. Click here for a link to the article.
As we previously reported, in November Mylan and Biocon submitted an aBLA to the FDA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Today, Mylan announced that the FDA has accepted its Mylan-Biocon’s aBLA. This is Mylan and Biocon’s first U.S. regulatory submission through the 351(k) pathway. The anticipated…
Goodwin announced today the release of its 2016 BPCIA Litigation Update and Thinking of Investing In a Biosimilars Product? The 2016 BPCIA Litigation Update recaps a busy year in the legal world of biosimilars, offering background, legal analysis and the status of the year’s most pivotal cases. Thinking of Investing…
We reported last week that a permanent injunction against the sale of Praluent® (alirocumab) was issued in Amgen v. Sanofi/Regeneron. The day after the court’s order, defendants filed a motion to stay the injunction while the decision is appealed to the Federal Circuit. Yesterday, Judge Robinson denied defendants’ motion to stay, noting that in the order…