Genentech’s Complaint Against Amgen Regarding MVASI® (bevacizumab-awwb)
October 18, 2017 Posted by
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.
Intas Launches Bevatas (bevacizumab) in India
October 17, 2017 Posted by
Intas, an Indian pharmaceutical company based in Ahmedabad, has launched BEVATAS (bevacizumab), a biosimilar to Roche’s AVASTIN, in India. Bevacizumab is used to treat colorectal cancer, ovarian cancer, cervical cancer, lung cancer and […]View More
Court Permits St. Regis Mohawk Tribe to Join Restasis® Litigation, but Nixes Allergan’s Patents
October 16, 2017 Posted by
Today, Judge Bryson, a Federal Circuit judge sitting by designation in the U.S. District Court for the Eastern District of Texas, Marshall Division, issued an Opinion and Order granting Allergan’s motion to join the […]View More
Upcoming FTC Workshop: Understanding Competition in Prescription Drug Markets
October 13, 2017 Posted by
The Federal Trade Commission (FTC) is hosting a workshop on November 8, 2017 at the Constitution Center in Washington, DC entitled: “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” The workshop will […]View More
AbbVie Answers BI’s Counterclaims in Adalimumab Litigation
October 13, 2017 Posted by
EMA Accepts Application for Cinfa’s Pegfilgrastim Biosimilar
October 12, 2017 Posted by
US FDA Issues CRL For Biocon and Mylan’s Pegfilgrastim Biosimilar
October 11, 2017 Posted by
As we posted previously, Biocon and Mylan are jointly developing a pegfilgrastim biosimilar, and have sought marketing authorization in the US. On October 10, Biocon reported that the FDA issued a Complete Response Letter (CRL). […]View More
GENENTECH FILES A COMPLAINT AGAINST AMGEN IN DELAWARE REGARDING MVASI® (BEVACIZUMAB-AWWB)
October 10, 2017 Posted by
We previously reported that on October 6, 2017, Amgen filed a declaratory judgment action against Genentech regarding Amgen’s recently approved biosimilar of Avastin® (bevacizumab-awwb). On the same day, Genentech filed a complaint in the District of Delaware, Civil […]View More
Amgen Files DJ Complaint Against Genentech Regarding Mvasi® (bevacizumab-awwb)
October 9, 2017 Posted by
On Friday, October 6, Amgen filed a complaint in the Central District of California seeking a declaratory judgment against Genentech that Mvasi® (bevacizumab-awwb), Amgen’s recently approved biosimilar of Avastin®, does not infringe […]View More
BREAKING NEWS: Federal Circuit vacates injunction against sale of Praluent®
October 5, 2017 Posted by
As we reported earlier this year, on January 5, 2017, Judge Robinson of the District of Delaware entered a permanent injunction prohibiting the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product after the defendants […]View More
