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…
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…
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…
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…
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…
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…
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…
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…
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…
For the past few years, Amgen has been asserting patents in a litigation against Sanofi and Regeneron Pharmaceuticals in the District of Delaware to prevent them from selling Praluent® (alirocumab),…
On January 3, 2017 in the Amgen v. Sanofi/Regeneron action, Judge Robinson denied Defendants’ motion for judgment in their favor as a matter of law (JMOL) and request for a…