As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year.
As was the case with last year’s recap
J.P Morgan states that the JP Morgan Healthcare Conference (“JPM”) “is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community”.
On January 15, 2025, Goodwin and KPMG will host their 6th Annual Symposium. Life sciences
As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space.
Here are some of the top regulatory developments from 2024.
1. FDA Approvals in 2024
There were 17 FDA approvals of Biologic License Applications (“BLAs”), including for Autolus Inc.’s AUCATZYL (obecabtagene autoleucel) for the treatment
As we previously reported, in April of last year, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC brought a lawsuit against Pfizer and BioNTech in the District Court for the District of Delaware, alleging that the COVID-19 vaccine, Comirnaty®, infringed five of their U.S. patents directed to mRNA vaccine technology—specifically, U.S. Patent Nos. 11,638,693; 11,638,694; 11,666,534;
On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia. According to the partnership agreement, Tabuk will hold the marketing authorization and be responsible to manufacture, register, import, and market BAT2206 in Saudi Arabia, leveraging
On December 18, 2024, Celltrion announced that the FDA has approved its ustekinumab biosimilar, STEQEYMA (ustekinumab-stba), referencing Jannsen’s STELARA. STEQEYMA is approved for subcutaneous injection or intravenous infusion in adult and pediatric patients for treatment of various psoriatic conditions, Crohn’s disease, and ulcerative colitis. STEQEYMA is the seventh ustekinumab biosimilar to be approved by the
On October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), asserting infringement of two patents. Over the last two calendar years, Amgen, Biogen, Genentech, and Regeneron have all filed BPCIA complaints (sometimes several) asserting 20 or more patents. Does this reflect a trend of Reference Product Sponsors
The European Medicines Agency’s (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars.
The CHMP recommended approval of four biosimilars developed by Celltrion: (1) AVTOZVMA (tocilizumab), for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced severe or life-threatening cytokine
This Monday, Bio-Thera Solutions announced that it would be expanding its Latin American biosimilar marketing partnership with SteinCares.
Previously, Bio-Thera and SteinCares had agreed to a partnership whereby Bio-Thera, a commercial-stage biopharmaceutical company, granted SteinCares, a Latin American specialty healthcare company, exclusive rights to market two of Bio-Thera’s biosimilars in the LATAM region. The
Jazz Pharmaceuticals’s ZIIHERA®
On November 20th, Jazz Pharmaceuticals announced that the FDA has approved ZIIHERA® (zanidatamab-hrii) on an accelerated basis for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. “The approval of Ziihera, which previously received Breakthrough Therapy Designation from the FDA for
