Welcome to the Big Molecule Watch!
Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.
If you’re looking for a primer on biologics, check out our background post
introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).
We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.
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 […]
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 […]
Last week, Sanofi-Aventis U.S. LLC filed a complaint
against Merck Sharp & Dohme Corp. over its proposed biosimilar to Lantus (insulin glargine injection). The complaint asserts that Merck will infringe 10 different U.S. patents […]
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 […]
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 […]
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
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 […]
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 […]
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 […]
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 […]