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…
The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim and pegfilgrastim) have submitted a joint case management statement regarding the two pending cases between the parties: Case No. 3:14-cv-04741-RS (accused product: Zarxio® (filgrsatim-sndz), which Sandoz launched in September, 2015) and Case No. 3:16-cv-02581-RS (accused product: pegfilgrastim (biosimilar to Amgen’s Neulasta®). The parties…
FDA has announced the opening of a docket (FDA-2016-N-2610) for interested parties (academic researchers, regulated industries, consortia, patient groups, etc.) to submit suggestions, recommendations and comments on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities and new biological therapeutics from October 2007 to December…
We have been closely following the Amgen v. Apotex case. On September 9, 2016, Apotex petitioned the Supreme Court for certiorari to review the Federal Circuit’s decision. In its petition, Apotex presents two questions for the Supreme Court: Whether the Federal Circuit erred in holding that biosimilar applicants that make…
On September 16, Hospira filed a petition for an inter partes review of Genentech’s U.S. Patent No. 7,807,799 which is directed to methods of purifying proteins, including trastuzumab. Trastuzumab is marketed by Genentech under the brand-name Herceptin®, and is indicated for the treatment of certain sub-types of breast cancer. The petition…
Today FDA announced that it will hold a public meeting on October 20, 2016 to discuss its proposed recommendations for the reauthorization of the Biosimilar User Fee Act, which permits FDA to collect fees and use them for the process for the review of aBLAs. The current legislative authority for BsUFA…
As we previously reported, over the past year several petitions requesting Inter Partes Review (IPR) of patents that claim foundational inventions for biologic drug production were filed. Here we discuss the scope of two of the foundational patents that are currently under consideration by the Patent Trial and Appeals Board…