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.
earlier this month that, in early October, Genentech filed a complaint under seal against Amgen in the District of Delaware based on Amgen’s FDA-approved aBLA for MVASI® (bevacizumab-awwb), a biosimilar of Avastin®. Yesterday, […]
, 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 […]
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 […]
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 […]
As we previously reported
, on August 2, 2017, AbbVie filed a
complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira® (adalimumab) product. We […]
Last week, Cinfa Biotech S.L. announced
that the European Medicines Agency (EMA) has accepted its application to market a molecule referred to as B12019, a biosimilar of Amgen’s Neulasta® (pegfilgrastim), for the treatment of […]
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). […]
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 […]
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 […]
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 […]