HUMIRA (adalimumab) Biosimilar Launches

GP
Goodwin Procter LLP

Contributor

At Goodwin, we partner with our clients to practice law with integrity, ingenuity, agility, and ambition. Our 1,600 lawyers across the United States, Europe, and Asia excel at complex transactions, high-stakes litigation and world-class advisory services in the technology, life sciences, real estate, private equity, and financial industries. Our unique combination of deep experience serving both the innovators and investors in a rapidly changing, technology-driven economy sets us apart.
In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market.
United States Food, Drugs, Healthcare, Life Sciences
To print this article, all you need is to be registered or login on Mondaq.com.

In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market: Boehringer Ingelheim's CYLTEZO (adalimumab-adbm); Sandoz's HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis's HADLIMA (adalimumab-bwwd); Coherus Biosciences's YUSIMRY (adalimumab-aqvh); Celltrion's YUFLYMA (adalimumab-aaty); Fresenius Kabi's IDACIO (adalimumab-aacf); and Biocon's HULIO (adalimumab-fkjb). With Amgen's AMJEVITA (adalimumab-atto), launched in January 2023, there are now 8 adalimumab biosimilar products available in the U.S. market.

Each of the new adalimumab biosimilar products are offered in autoinjector and prefilled syringe options. CYLTEZO, YUSIMRY, IDACIO, and HULIO are available as a 50 mg/ml formulation, YUFLYMA is available as a 100 mg/ml formulation, and HYRIMOZ and HADLIMA are available as both 50 mg/ml and 100 mg/ml formulations. Boehringer Ingelheim's CYLTEZO is the only approved adalimumab biosimilar that FDA has approved as interchangeable to HUMIRA.

Pfizer's ABRILADA (adalimumab-afzb) is also expected to launch in 2023.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

See More Popular Content From

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More