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 European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 215, their proposed biosimilar of Avastin®…
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 transfer that complaint to the Central District of California, where Amgen had previously filed a declaratory judgment action against the same patents that Genentech later…
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 report. Among other things, the parties offered their competing proposals for the schedule and the scope of discovery, including limits on the number…
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,…
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…
Last week, Cinfa Biotech S.L. announced that the European Medicines Agency (EMA) has accepted its application to market a molecule referred to as B12019, a biosimilar of Amgen’s Neulasta® (pegfilgrastim), for the treatment of chemotherapy-induced neutropenia. To support its application, Cinfa conducted two studies confirming the analytical and biofunctional similarity…
As we noted earlier today, this week the Federal Circuit is holding oral argument at various venues in New York City. Two of today’s oral arguments were in biosimilar cases that we have been closely following on this blog. Janssen v. Celltrion The morning began with a panel of Judge…
Last Friday, Samsung Bioepis filed IPR2017-02139 and IPR2017-02140, directed to Genentech’s U.S. Patent No. 6,407,213. According to the petitions, the ‘213 patent claims are directed to “humanized antibodies with non-human residues in the Complementarity Determining Regions (‘CDRs’) as well as in the framework region at certain, specified positions.” The petitions…
Today Sandoz filed IPR2018-00002, directed to AbbVie’s U.S. Patent No. 9,512,216. According to the petition, the ’216 patent claims a subcutaneously-administered dosing regimen for the anti-TNF-α antibody adalimumab, the active ingredient in AbbVie’s Humira ® product, to treat moderate to severe chronic plaque psoriasis. This is the second petition Sandoz…
Last week, FDA issued its latest draft guidance on biosimilar products and implementation of the BPCIA. The draft guidance, titled Statistical Approaches to Evaluate Analytical Similarity, “describes the type[s] of information a sponsor of a proposed biosimilar product should obtain” to support a showing of analytical similarity to a licensed…