Amgen today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has “adopted a positive opinion” for marketing of Amgen’s biosimilar adalimumab, “recommending approval for all available indications.” Amgen’s biosimilar adalumimab was approved in the United States on September 23, 2016. The CHMP’s…
Yesterday, during its Q4 2016 earnings call, Novartis CMO Vasant Narasimhan told investors that its subsidiary Sandoz had delayed filing its aBLA for a biosimilar of Humira® (adalimumab), which originally had been planned for Q4 2016. According to Mr. Narasimhan, Sandoz has “pushed [the filing] into the first half of…
The Supreme Court has ordered a briefing schedule in Amgen v. Sandoz. Because the Court granted and consolidated Sandoz’s petition and Amgen’s conditional cross-petition, the Court has adopted a four-brief schedule, comparable to the procedure used in the courts of appeals. According to the order, the briefing schedule will be as…
As we reported last August, the FDA has already approved Erelzi®, Sandoz’s biosimilar version of Amgen’s psoriasis drug Enbrel.® However, the head of generics at Novartis (Sandoz’s parent) told Reuters this week that their biosimilar product will likely not go on sale before 2018 because of ongoing patent protection issues. Stay tuned for…
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…
As previously posted, President Trump has stated that he planned to issue a notification of intent to withdraw from the Trans-Pacific Partnership (TPP), which is a proposed trade agreement between several pacific countries concerning (among other things) intellectual property and pharmaceutical products. While President Obama had approved a deal on…
With the pre-trial conference set to begin on February 6, 2017, the parties in Janssen v. Celltrion have filed several motions seeking to exclude or limit certain evidence and testimony that may be offered at trial. Expert Testimony Celltrion has filed a motion to exclude the opinions of Janssen’s proffered expert…
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…