As we previously reported, the Centers for Medicare and Medicaid Services (“CMS”) has been considering comments on a proposed rule regarding biosimilar payment policies. On Thursday, CMS issued a final rule for the 2018 Physician Fee Schedule, which includes a change to the biosimilar payment policy. Prior to the issuance of this…
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…
As we previously reported, earlier this year Biocon requested withdrawal and re-submission of its Marketing Authorization Applications for its trastuzumab and pegfilgrastim biosimilars with the European Medicines Agency (EMA), as part of the EMA’s procedural requirements linked to the re-inspection of Biocon’s facility. Today, Biocon’s partner Mylan re-submitted the applications…
Today, Boehringer Ingelheim announced new one-year data for their adalimumab biosimilar, Cyltezo®. VOLTAIRE®-RA, a 48 week Phase III clinical trial, compared Cyltezo® (adalimumab-adbm) to Humira. The results showed that Cyltezo® has equivalent efficacy, safety, and immunogenicity to Humira. The data also showed consistent results when patients were switched to Cyltezo® from the reference product. …
In a move that has attracted attention from industry, the judiciary, and Congress, Allergan, Inc. assigned its rights to patents covering its Restasis® dry eye treatment to the St. Regis Mohawk Tribe (“Tribe”) and simultaneously licensed back those patents in exchange for the Tribe’s agreement to invoke tribal sovereign immunity in inter…
Below are some highlights from third quarter earnings reports recently released by biologics and biosimilar companies. Johnson & Johnson reported that Remicade (infliximab) sales declined more than 1% in the U.S. and more than 8% worldwide year-over-year. During its earnings call, company executives explained that two-thirds of the decline in sales in Europe…
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…
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…