Earlier this week, the United States Supreme Court denied Amphastar Pharmaceutical’s petition for certiorari regarding the scope of the safe-harbor of 35 U.S.C. § 271(e)(1), a provision that generic drug and biosimilar makers often rely upon to shield their manufacturing and testing activities from claims of patent infringement. The case…
As we reported in August, Samsung BioLogics, the biologic drug arm of Samsung Group was planning to raise USD$2.5 billion through an IPO. Yesterday Samsung BioLogics priced 16.5 million shares, valuing the company at as much as USD$8.2 billion. Whereas Samsung BioLogics is a contract manufacturer of biologic drugs, its…
Amgen has filed its answer in response to AbbVie’s complaint alleging infringement of 10 patents that allegedly cover Amgen’s recently-approved adalimumab biosimilar, Amjevita (formerly known as ABP501). Amgen asserts that AbbVie’s responses to its aBLA and required disclosures were deficient. Specifically, Amgen asserts that AbbVie did not provide an adequate…
As we previously reported, after the district court found that all the asserted claims of the ’471 patent were invalid for obviousness-type double patenting, Celltrion moved for entry of final judgment on that patent under Federal Rule of Civil Procedure 54(b), even though Janssen’s infringement claims regarding the ’083 patent…
Shire plc has returned development rights to two biosimilar candidates to Coherus BioSciences, Inc. and Momenta Pharmaceuticals, Inc., reportedly based on a strategic portfolio review following Shire’s June 2016 acquisition of Baxalta Incorporated. Coherus announced that it has “regained from Shire plc all development and commercial rights previously licensed for…
On September 23, the FDA denied a citizen petition from AbbVie submitted to the FDA on April 2, 2012, requesting that the FDA not implement the BPCIA as to any applications for biosimilar products referencing Humira (adalimumab), or any other product for which the BLA was submitted to the FDA…
Samsung Bioepis is reportedly seeking regulatory approval to sell a biosimilar version of Humira® (adalimumab) in South Korea. Also, in July 2016, Samsung Bioepis reported that the EMA had accepted its Marketing Authorization Application for SB5, an adalimumab biosimilar. As we recently reported, Samsung Bioepis already has approved biosimilar applications for etanercept and…
According to a report this morning from Seeking Alpha, FDA is expected to approve Amgen’s application for a biosimilar version of AbbVie’s Humira (adalimumab) today. If approved, it will be the first biosimilar adalimumab product approved by FDA, and the fourth product to be approved under the BPCIA’s abbreviated approval pathway for biosimilars…
Last week, Sanofi-Aventis U.S. LLC filed a complaint against Merck Sharp & Dohme Corp. over its proposed follow-on biologic to Lantus (insulin glargine injection). The complaint asserts that Merck will infringe 10 different U.S. patents with its follow-on biologic product. According to the complaint, Merck has submitted an NDA seeking…
On September 20, Teva Pharmaceutical Industries Ltd. and Regeneron Pharmaceuticals, Inc. announced an agreement to develop and commercialize fasinumab, an investigational NGF antibody currently under development by Regeneron as a treatment for osteoarthritis and chronic low back pain. The press release states Teva and Regeneron will collaborate globally, excluding Japan, Korea, and…