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®…
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® (infliximab-abda), a biosimilar of Remicade® that was approved by FDA a month earlier and subsequently launched in July 2017. Janssen’s…
Earlier this week the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (“PTAB”) published a Final Rule regarding the scope of the attorney-client privilege in proceedings before the PTAB. The Rule states that any “communication between a client and a USPTO patent practitioner or a foreign jurisdiction patent practitioner that…
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…