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.
Last Thursday, October 20, the FDA held a scheduled public meeting
on the reauthorization of the Biosimilar User Fee Act (BsUFA). The FDA heard from a wide spectrum of stakeholders, including patient/public […]
Yesterday, Catalent Pharma Solutions announced
that it has broken ground for a 22,000 square foot extension of its biologics manufacturing facility in Madison, Wisconsin. According to the press release, following completion of the expansion, […]
Mylan filed an amicus brief in support of Apotex’s petition for certiorari
in Amgen v. Apotex
. Mylan’s arguments focus on the Federal Circuit’s interpretation of the BCPIA as requiring 180 days of pre-marketing notice after
As we previously reported
, on September 26, 2016, the district court in Janssen v. Celltrion entered
partial final judgment that the ’471 patent, asserted by Janssen, was invalid. Today, Janssen filed a notice that they are
On October 19, Fujifilm Kyowa Kirin Biologics (a joint venture between Fujifilm and Kyowa Hakko Kirin), announced successful results in the global Phase 3 study of its Humira® (adalimumab) biosimilar candidate, FKB327. According to […]
Earlier this week, we reported on the amicus curiae brief filed by the Biosimilars Council
in support of Apotex’s petition in Amgen v. Apotex
. Mylan Pharmaceuticals Inc. has also filed an amicus brief in […]
A study conducted by the Norwegian government compared Johnson & Johnson’s Remicade (infliximab) to Celltrion’s approved biosimilar Remsima. The “NOR-SWITCH” study, which cost $2.5 million, was a 52-week Phase IV study that began in October 2014. […]
On October 17, the PTAB denied institution of IPR2016-000912
. The Petitions in these cases were filed by Swiss Pharma International AG on U.S. Patent Nos. 8,815,236; 8,349,321; and 8,900,577, respectively, […]
The Economic Times of India has reported
on a study of the Indian biosimilars market conducted by the Jawaharlal Nehru Institute of Advanced Studies (JNIAS). The study reports that the Indian biosimilars industry was […]
As we covered in a previous post
, Apotex has filed a cert. petition asking the Supreme Court to review the Federal Circuit’s ruling on the BPCIA’s notice provision in Amgen v. Apotex
. Last […]