Yesterday, Samsung Bioepis announced that the FDA has accepted for review the company’s BLA under the 351(k) pathway for SB3, a biosimilar candidate referencing Genentech’s Herceptin® (trastuzumab). The press release states that this is Samsung Bioepis’ first submission for FDA-approval of an oncology biosimilar candidate. According to the press release,…
With the pre-trial conference set to begin on February 6, 2017, the parties in Janssen v. Celltrion have filed several motions seeking to exclude or limit certain evidence and testimony that may be offered at trial. Expert Testimony Celltrion has filed a motion to exclude the opinions of Janssen’s proffered expert…
As we previously reported, on September 26, 2016, the district court in Janssen v. Celltrion entered partial final judgment that the ’471 patent, asserted by Janssen, was invalid. Today, Janssen filed a notice that they are appealing the district court’s judgment to the Federal Circuit. Meanwhile, Celltrion’s partner Pfizer announced last week that it will begin shipping…
A few BPCIA litigation updates to wrap up the week for our readers, looking ahead to next week: The Federal Circuit issued its formal mandate in Amgen v. Apotex yesterday. With the issuance of the formal mandate, the Federal Circuit has officially ordered that its July opinion in the case must now be…