Mylan N.V. and Biocon Ltd. have announced that the FDA has accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Amgen’s Neulasta®…
Mylan N.V. and Biocon Ltd. have announced that the FDA has accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Amgen’s Neulasta®…
Sandoz filed its opening brief to the Supreme Court on Friday, February 10, 2017. The dispute focuses on the notice marketing provision and the information exchange or “patent dance”…
The parties in Amgen v. Apotex have completed briefing in Amgen’s appeal to the Federal Circuit from the district court’s judgment of noninfringment. As we have previously reported, in…
According to BioPharma-reporter, Pfizer will close the Australian plant at which Pfizer manufactures API for HSP-130, a biosimilar version of Amgen’s Neulasta, by 2021. Pfizer will move…
Sandoz filed its opening brief on Friday. Amicus briefs are due on February 17, and the full briefing schedule is available in our prior post. Big Molecule Watch will provide…
On yesterday’s earnings call for Q4 2016, Amgen indicated that it is projecting its Neulasta® (pegfilgrastim) product to face biosimilar completion in the U.S. by the end of the year….
Over the past week or so, several biologic and biosimilar companies have issued their year-end earnings reports. Below are some highlights on the biosimilar front: Pfizer recently reported in…
Today, Coherus Biosciences filed four petitions for inter partes review of Abbvie’s U.S. Patent 9,085,619 (IPR2017-00822, IPR2017-00823, IPR2017-00826, and IPR2017-00827). According to the…
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…