On January 13, 2017, the FDA published a final version of its industry naming guidance Nonproprietary Naming of Biological Products. In it, the FDA specified a naming convention that gives biosimilar products and their reference products distinguishable, nonproprietary names. Today, the FDA published a follow up letter responding to the pending citizen…
On Friday, Hospira filed the following petitions – IPR2017-00731 (U.S. Patent No. 7,846,441), and IPR2017-00737 and IPR2017-00739 (both for U.S. Patent No. 7,892,549). According to these petitions, the patents are drawn to methods of using trastuzumab in combination with certain other agents for the treatment of cancers. Trastuzumab is the active…
Samsung Bioepis, Biogen, and Fujifilm Kyowa Kirin Biologics are seeking to invalidate some of AbbVie’s patents related to Humira® (adalimumab) before the UK High Court of Justice. The patents at issue relate to methods of treatment. AbbVie attempted to have the case dismissed after offering to abandon the patents at…
Coherus Biosciences announced “positive topline 24-week treatment phase three results” in patients with psoriasis for CHS-1420, its proposed biosimilar to Humira® (adalimumab). Coherus stated that it anticipates filing its Biologic License Application (BLA) in the first half of 2017. Coherus previously reported positive topline results from this ongoing trial, and indicated…
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’…
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…
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…
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…
In March 2016, a Federal Circuit panel issued a decision in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc. in which it held that Mylan was subject to specific personal jurisdiction in the District of Delaware because Mylan had submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval…