Being ten years in since the enactment of the BPCIA provides us a great opportunity to take a look back at how things have developed in the world of biosimilar…
Being ten years in since the enactment of the BPCIA provides us a great opportunity to take a look back at how things have developed in the world of biosimilar…
Teva and Celltrion announced yesterday that their HERZUMA (trastuzumab-pkrb) for Injection, a biosimilar to HERCEPTIN, was available in the U.S. The biosimilar has the same indications as the…
The Korean Herald reported today that Celltrion has applied for the European Medicine Agency’s approval of CT-P17, a Humira (adaliumumab) biosimilar. According to the Korean Herald, Celltrion…
Today, the Federal Circuit issued a Rule 36 affirmance of the district court’s judgment of non-infringement in the litigation involving Celltrion’s infliximab biosimilar. The court heard oral…
Below we provide an update on some recent developments from several biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Immunex Rhode Island, Fed. Cir. Case No. 19-2155 –…
Multiple sources are reporting that Celltrion is planning to roll out REMSIMA SC, its subcutaneous infliximab biosimilar of Johnson & Johnson’s autoimmune disease treatment REMICADE, in Europe…
Below are some recent developments in the biosimilar industry from around the globe: On January 14, 2020, Alvotech announced that it entered into a partnership with Canada-based JAMP Pharma for…
As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order: 1) Launch…
Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning…
Below are highlights of recent developments in biosimilar clinical trials. On December 9, Celltrion presented the results from a phase 3 clinical trial that demonstrated similar safety and efficacy…