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.
Ireland’s Department of Health (the “Department”) recently reported on its website
that it is “developing a National Biosimilar Medicines Policy to promote the use of biosimilar medicines and to create a sustainable environment for […]
As we’ve posted here
, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (Pegfilgrastim) and Ogivri (Trastuzumab), and have filed applications for marketing authorization in the European Union (EU) for those products. […]
As we have previously reported, on July 25th, Coherus filed a motion
to stay discovery pending the result of its motion to dismiss in its litigation against Amgen regarding pegfilgrastim, and Amgen filed […]
On August 8, Sanofi-Aventis filed a complaint
for patent infringement against Merck Sharp & Dohme in the U.S. District Court for the District of New Jersey regarding Merck’s proposed follow-on biologics of Sanofi-Aventis’s Lantus® and […]
Coherus Biosciences filed a petition at the US Patent and Trademark Office last week, seeking to cancel the claims of U.S. Patent 8,163,522 (the ’522 patent), entitled “Human TNF Receptor,” and assigned on its face […]
Mazumdar-Shaw, Chairman & Managing Director of Biocon, recently stated that Biocon is developing a portfolio of 10 biosimilars
, and will continue to invest 12-15% of its revenue in research and development. According to Ms. […]
Today, the Federal Circuit dismissed
Amgen’s appeal from and mandamus petition regarding the U.S. District Court for the Delaware’s order denying Amgen’s motion to compel discovery for lack of jurisdiction under the collateral order doctrine. […]
On July 31, Express Scripts identified
new formulary exclusions that will go into effect on January 1, 2018. For example, Amgen’s rG-CSF product, NEUPOGEN, will be excluded
in favor of Teva’s rG-CSF […]
completion of initial phases of the Biologic Price Competition and Innovation Act patent exchange with Amgen for its pegfilgrastim biosimilar candidate CHS-1701. Coherus reported that it has received a complete response […]
In response to Coherus’s motion to stay discovery
in Amgen v. Coherus
, Amgen filed an answering brief
yesterday opposing this motion. Amgen claimed that any delay in the proceedings would “unduly prejudice […]