Merck forges ahead with phase 3 trial of Humira biosimilar
- Merck in Germany (formally Merck KGaA) is initiating phase 3 trials of its biosimilar version of AbbVie's blockbuster Humira. The trial will test the biosim MSB11022 against Humira for treatment of plaque psoriasis.
- Several companies, including Amgen, Sandoz, and Boehringer Ingelheim are working develop a biosimilar version of AbbVie's Humira, hoping to muscle in on its $13 billion market.
- Humira is indicated for a wide range of autoimmune diseases including rheumatoid arthritis, Crohn's disease, and plaque psoriasis.
Humira's $13 billion in sales makes for a very attractive target. As many of the patents in this market will expire this year in the U.S. and next year in the E.U., there continues to be intense patent disputes and efforts to shore up patent protection.
Patients in India already have access to Zydus Cadila's biosimilar version of Humira, which was approved in that market in 2014. However, other markets have proved more challenging. Amgen, for example, has seen its version of biosimilar Humira, ABP501, delayed a number of times. This has pushed back its probable launch date to 2017.
For its part, Merck is only going after one of Humira's indications—chronic plaque psoriasis. MSB11022 will be tested in a randomized, double-blind, active-controlled trial to test its efficacy, safety and immunogenicity in patients with moderate to severe chronic plaque psoriasis.
The study will be a multinational, multi-center study and involve roughly 400 patients.
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