Celltrion Submits Denosumab BLA to FDA: On November 30, 2023, it was reported that Celltrion had completed submission of its application to the FDA for CT-P41, its denosumab biosimilar of Amgen’s PROLIA and XGEVA....more
As previously reported, in February 2023, Formycon and Fresenius Kabi entered into a global license agreement to commercialize FYB202, a ustekinumab biosimilar of Janssen’s STELARA, in key global markets after...more
Today, the Nobel Assembly at Karolinska Institutet announced that the Nobel Prize in medicine was awarded to Katalin Karikó and Drew Weissman “for their discoveries concerning nucleoside base modifications that enabled...more
It has been reported that Celltrion has finalized a settlement with Johnson & Johnson (“J&J”) in the United States relating to CT-P43, Celltrion’s ustekinumab biosimilar to J&J’s STELARA®, which would permit Celltrion to...more
Alvotech and Teva announced an expansion of their existing strategic partnership agreement relating to biosimilars products in the U.S. According to the announcement, the existing agreement includes AVT02, an...more
Celltrion and US-based Rani Therapeutics (“Rani”) announced that they entered an agreement to develop RT-105, an orally administered adalimumab biosimilar made using the RANIPILL platform....more
Alvotech and Teva Pharmaceuticals, Inc. announced that they reached a settlement and license agreement with Johnson & Johnson regarding AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab) in the United States....more
We previously reported on Janssen’s complaint alleging that Amgen’s filing of an aBLA for ustekinumab, a biosimilar of STELARA, infringes Amgen patents, and about Janssen seeking a preliminary injunction to block Amgen from...more
In 2017, three indirect-purchaser antitrust class actions were filed against Johnson & Johnson and Janssen Biotech, Inc., alleging that they engaged in anticompetitive conduct relating to the sale and marketing of J&J’s...more
4/13/2023
/ Abuse of Dominance ,
Anti-Competitive ,
Antitrust Litigation ,
Antitrust Provisions ,
Attorney's Fees ,
Class Action ,
Discovery ,
Janssen Pharmaceuticals ,
Johnson & Johnson ,
Pfizer ,
Settlement
Alteogen Inc. announced that it entered an exclusive license agreement with Sandoz AG pursuant to which Sandoz will have world-wide rights to use Alteogen’s ALT-B4 hyaluronidase, derived using Hybrozyme™ Technology, to...more
On November 16, FDA approved Eli Lilly’s REZVOGLAR (insulin glargine-aglr) as the second interchangeable biosimilar to LANTUS (insulin glargine), joining SEMGLEE (insulin glargine-yfgn), which was previously approved as...more
Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars for the Japanese market. Pursuant to...more
Apotex Inc. recently filed an IPR petition, IPR2022-01524, seeking cancellation of claims 1-14 and 26-30 of U.S. Patent No. 11,253,572 assigned to Regeneron Pharmaceuticals, Inc. The challenged claims generally relate...more
In May 2022, Xbrane announced that it had withdrawn its biologics license application (BLA) for its ranibizumab biosimilar of LUCENTIS®....more
On June 7, 2022, from 9:30-10:50 AM Eastern Time, FDA is hosting, virtually, its annual public meeting for public comment on Financial Transparency and Efficiency of the Prescription Drug User Fee Act (PDUFA), Biosimilar User...more
The U.S. Attorney’s Office for the Northern District of California has announced that Racho Jordanov, a co-founder and former Chief Executive Officer of JHL Biotech, and Rose Lin, a co-founder and former Chief Operating...more
On February 4, 2022, Nova Scotia announced that as part of the Nova Scotia biosimilar initiative, Nova Scotians enrolled in Pharmacare programs will have 12 months (until February 3, 2023) to work with their healthcare...more
We have previously reported on AbbVie’s first and second wave suits against Alvotech hf. (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the second wave suit, on December 21, 2021,...more
Earlier this year, AbbVie Inc. and AbbVie Biotechnology Ltd. filed a Complaint against Alvotech hf. in the US District Court for the Northern District of Illinois alleging theft of trade secrets relating to adalimumab. In...more
We have previously reported on AbbVie’s first and second wave suits against Alvotech hf (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the first wave suit, on October 5, 2021 AbbVie...more
12/14/2021
/ AbbVie ,
Affirmative Defenses ,
Biosimilars ,
Counterclaims ,
Failure To State A Claim ,
Inequitable Conduct ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Personal Jurisdiction ,
Pharmaceutical Patents ,
Subject Matter Jurisdiction ,
Unclean Hands
It has been reported that U.S. pharmacy benefit manager CVS will drop Sanofi’s insulin drugs, Lantus® (insulin glargine injection, 100 units/ml) and Toujeo® (insulin glargine injection, 300 units/ml) from the list of...more