Yesterday, Momenta and Mylan reported that initial results obtained from their proposed abatacept biosimilar M834 did not meet primary pharmacokinetic endpoints in a Phase I study comparing the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in 243 normal healthy volunteers. The Phase I study was a randomized,…
This week Roche reported that FDA has accepted their supplemental Biologics License Application (sBLA) for Avastin® (bevacizumab) “in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer.” The sBLA is for the use of Avastin® with carboplatin and paclitaxel,…
The United States District Court for the District of Massachusetts has denied Celltrion’s motion to dismiss the action for lack of standing. As we previously reported, Celltrion argued that certain co-owners of the ’083 patent-in-suit were not parties to the action when Janssen filed its 2015 complaint, and that Janssen’s attempts to…
Last year we reported the FDA approval and then U.S. launch of Inflectra®, a biosimilar of Remicade® (infliximab). This week, Pfizer and Celltrion Healthcare have reported that the results of a Phase 3 study of Inflectra demonstrated that “switching patients with Crohn’s disease (CD) to Inflectra from Remicade® (infliximab) led…
The PTAB remains a busy venue for biologics patents. Here are some IPR updates from the weeks since our last IPR update: HERCEPTIN On October 4, the Board instituted IPR on four petitions that Celltrion had filed on Genentech patents related to Herceptin® (trastuzumab): IPR2017-01121 (challenging U.S. Patent 7,846,441); IPR2017-01122 (challenging U.S. Patent No….
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 data package submitted as part of the Marketing Authorization Application “strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms of safety,…
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) product in the United States until expiration of the patents-in-suit. Today, Amgen filed a motion to extend the time for it to file…
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 those patents are invalid, and that one of the patents is unenforceable for inequitable conduct. Today, Amgen and Genentech submitted a stipulated briefing and hearing…
A recent study evaluated the efficacy, safety, and immunogenicity of switching from reference infliximab (Remicade®, Janssen Biotech), to the biosimilar SB2 (Renflexis®, Samsung Bioepis), in patients with moderate to severe rheumatoid arthritis. This study was an extension of a multinational, multi-center phase III study of SB2, which had reported results…
On October 23, 2017, FDA announced the release of new educational materials to help health care professionals understand what biosimilars are and how they are approved. The materials include four fact sheets and graphics that provide definitions for relevant terminology, describe the biosimilar approval process, and explain the benefits of biosimilars. FDA also created social media posts for external…