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.
Aragen Bioscience, Inc. and Transposagen Biopharmaceuticals, Inc. have filed three petitions for IPR of Kyowa Hakko Kirin Co., Ltd.’s patents: IPR2017-01262
on U.S. Patent 7,425,446; IPR2017-01252
on U.S. Patent 6,946,292; and IPR2017-01254
On March 29, Senator Al Franken and fifteen co-sponsoring Senate Democrats introduced a bill called the “Improving Access to Affordable Prescription Drugs Act” (S. 771
). A companion bill (H. 1776
) with […]
On April 3, 2017, the Federal Circuit heard oral argument concerning the discovery dispute between Amgen and Hospira in their litigation concerning Hospira’s proposed biosimilar of Amgen’s product Epogen®/ Procrit® (epoetin alfa) (audio available here
Lanka Business News
is reporting that Celltrion and George Steuart Health have teamed up to launch Remsima (infliximab) in Sri Lanka. According to the article, this is the first biosimilar available in Sri Lanka. The […]
On April 5, Immunex (a wholly-owned subsidiary of Amgen) filed a complaint against Sanofi and Regeneron related to Sanofi and Regeneron’s Dupixent® (dupilumab) product, which received FDA approval
last week. Immunex’s complaint was filed in the District […]
The PTAB issued a Final Written Decision
in IPR2016-00258, wherein Petitioner Green Cross Corp. challenged claims 1-3, 16, and 17 of Shire Human Genetic Therapies, Inc.’s U.S. Patent No. 9,051,556. Green Cross, which is […]
JHL Biotech announced
today that China’s FDA has accepted its application for the use of JHL1101 in Phase 1 and Phase 3 clinical trials in non-Hodgkin’s lymphoma patients. JHL1101 is a rituximab biosimilar candidate that […]
We are continuing to see regulatory and commercial activity in the biologics space with companies pursuing new indications and approvals. Amgen announced
today both the submission of a supplemental BLA to the FDA and an […]
last week that the FDA has granted priority review for a supplemental BLA for BLINCYTO (blinatumomab). BLINCYTO received approval in 2014 for Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. With the […]
In a press release
, Roche announced today that FDA’s Oncologic Drug Advisory Committee has voted unanimously in favor of a subcutaneous injection of rituximab for the treatment of certain blood cancers, including previously untreated […]