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.
On July 4, 2017, BIOCAD, a Russia biotechnology company, announced
that in August 2017, it expects to receive permanent market authorization in India for Acellbia, its rituximab biosimilar. BIOCAD reports that its first shipment […]
Pfizer has filed two petitions for IPR of U.S. Patent 8,591,897, owned by Genentech: IPR2017-01726
. According to the petitions, the ‘897 patent is directed to methods for treating patients […]
As we reported here
on June 12, 2017, Coherus BioSciences received a complete response letter (“CRL”) from the FDA for its biologics license application for its pegfiltrastim (Neulasta®) biosimilar. On June 21, 2017, in […]
On July 5, 2017, Daiichi Sankyo Company announced
that it has decided to discontinue the development of CHS-0214, an investigational biosimilar to Amgen’s Enbrel® (etanercept), in Japan. Daiichi had been co-developing CHS-0214 with Coherus […]
Yesterday, in Amgen v. Hospira,
Amgen filed a redacted copy of Amgen’s amended opening brief in support of its motion for preliminary injunction (PI). As we previously reported
, Amgen filed a revised brief […]
As we have previously reported
, on June 12, 2017, the Supreme Court issued a unanimous opinion in Amgen v. Sandoz
holding that notice of commercial marketing may be given prior to FDA approval. The […]
Celltrion and Teva announced today
that the FDA has accepted for standard review their BLA for CT-P10 and that regulatory action is expected in the first quarter of 2018. CT-P10 is a proposed biosimilar to […]
The FDA announced
that it is soliciting public comments on the statement of work
for the assessment of its proposed new model for the review […]
Yesterday, RAPS reported
that the FDA is expecting the first interchangeable biosimilars to become available in the U.S. market within the next two years. Interchangeable biosimilars are those that “can be expected to produce the […]
On Wednesday, June 28, 2017, at 12:00 PM EST, Goodwin will host a webinar discussing the Supreme Court’s Decision in Sandoz v. Amgen
. On June 12, the Supreme Court decided Sandoz v. Amgen
, which presented […]