Below are regulatory and development updates regarding a number of biosimilar candidates. Today, Amgen and Allergen announced that the Committee for Medicinal Products for Human Use (CHMP) of the…
Below are regulatory and development updates regarding a number of biosimilar candidates. Today, Amgen and Allergen announced that the Committee for Medicinal Products for Human Use (CHMP) of the…
On May 17, 2017, Janssen sued Samsung Bioepis in the District of New Jersey for patent infringement under the BPCIA based on Samsung Bioepis’s filing of its aBLA for Renflexis®…
We reported earlier on Genentech’s complaint in the District of Delaware alleging that Amgen’s MVASI™ (bevacizumab-awwb) infringes over twenty Genentech patents, and Amgen’s motion to…
Below are some highlights from third quarter earnings reports recently released by biologics and biosimilar companies. Johnson & Johnson reported that Remicade (infliximab) sales declined…
Below is an update on recent developments in several litigations involving biosimilar products. AbbVie v. Boehringer Ingelheim (adalimumab): On October 23, the parties filed a joint status…
Today, Sandoz announced that its biosimilar of Neulasta® (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review. According to the press release, the…
Earlier this month, the Federal Circuit vacated an injunction in the Amgen v. Sanofi litigation that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab)…
We previously reported on Amgen’s complaint, in the Central District of California, seeking a declaratory judgment that MvasiTM (bevacizumab-awwb) does not infringe 27 Genentech patents, that…
Further to our update yesterday on the Amgen v. Hospira litigation, the parties in the case filed several additional motions yesterday. Following its filing of a motion for judgment as…
As we previously reported, on September 22, 2017, a Delaware federal jury awarded Amgen $70 million in damages after finding that Hospira infringed one of Amgen’s Epogen® (EPO) patents (the…