Samsung Bioepis, Celltrion speed up launch of Humira biosim this year

Samsung Bioepis plans to release Hadlima (Imraldi in Europe), a Humira biosimilar, in July in collaboration with its U.S. partner Organon & Co. [Image source: Samsung Bioepis]

A total of 10 Humira (adalimumab) biosimilars are scheduled to be released in the U.S. this year alone as U.S. and Korean manufacturers are speeding up their commercial development after AbbVie Inc., the marketing authorization holder for adalimumab, recently reached an agreement on patent rights.

Sales of the world’s best-selling biological agent amounted to $20.7 billion in 2021.

According to sources on Monday, U.S. Amgen will launch its Humira biosimilar Amjevita on Tuesday.

Among Korean companies, Samsung Bioepis Co. and Celltrion Inc. are leading the pack.

Samsung Bioepis plans to release Hadlima (Imraldi in Europe), a Humira biosimilar, in July in collaboration with its U.S. partner Organon & Co.

Celltrion also set July as a target timeframe for the launch of Yuflyma, its biosimilar version of Humira, in the U.S. The company is awaiting regulatory approval of the medicine.

In addition to Humira, the Korean manufacturers are active for biosimilars for Eylea, an eye disease biologic drug, and Stelara, an autoimmune disease medicine, as their patent protection will expire in June and September, respectively, this year.

Samsung Bioepis already completed a phase 3 clinical trial to compare Eylea and its biosimilar, SB15. A phase 3 clinical trial of SB17, a biosimilar to Stelara, was recently completed.

Celltrion is conducting a global phase 3 clinical trial of CT-P42, a biosimilar to Eylea. The efficacy and safety of CT-P43, a biosimilar of Stelara, were demonstrated in a recent global phase 3 clinical trial.