As we previously reported, yesterday the Federal Circuit affirmed the Southern District of Florida’s finding of non-infringement in Amgen v. Apotex. In that case, Amgen asserted the ’138…
As we previously reported, yesterday the Federal Circuit affirmed the Southern District of Florida’s finding of non-infringement in Amgen v. Apotex. In that case, Amgen asserted the ’138…
As we previously reported, Amgen appealed the Southern District of Florida’s judgment of non-infringement in favor of Apotex in litigation regarding Apotex’s proposed filgrastim and pegfilgrastim…
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…