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…
Big Molecule Watch is here to keep you up to date with conferences near and far. Biosimilars Congress India 2016 will take place in Hyderabad, India from October 13-14th. Registration is open and you can even request the proposed agenda ahead of time. The 6th International Conference and Exhibition on…
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…
Today, the USPTO released a notice of proposed rulemaking (set to be published on October 3 in the Federal Register) setting and adjusting patent fees (including fees for post-grant proceedings) during fiscal year 2017.
FDA has published its performance goals and procedures (commonly referred to as FDA’s “goals letter” or “commitment letter”) for the Biosimilar Biological Product User Fee Act (“BsUFA”) reauthorization for fiscal years 2018 – 2022, ahead of its upcoming public meeting on October 20, 2016 to discuss FDA’s proposed recommendations for the BsUFA reauthorization….
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…