Merck begins late-stage trials of Humira biosimilar
pharmafile | March 2, 2016 | News story | Research and Development, Sales and Marketing | AbbVie, Humira, Merck, biosimilars
Merck has announced the beginning of a global phase III study of its Humira (adalimumb) biosimilar, MSB11022, in chronic plaque psoriasis.
The study will compare the safety and efficacy of the German-based company’s biosimilar to that of AbbVie’s bestselling blockbuster. AURIEL is expected to recruit approximately 400 patients across Europe, Asia and North and Central America, Merck said.
Adalimumab is a recombinant human monoclonal antibody that binds to a specific cell signalling protein, blocking interaction with its cell surface receptors and thereby reducing inflammation. While this trial will see Merck’s candidate tested in plaque psoriasis, adalimumab is also used to treat a range of chronic inflammatory conditions, including rheumatoid arthritis, ulcerative colitis and Crohn’s disease.
The trial is being conducted by Merck’s Switzerland-based biosimilar division. Michael Soldan, head of that division, comments: “With the first patient now treated in our adalimumab biosimilar candidate study, we are moving closer to expanding access to affordable, high quality biologics for people living with serious diseases.”
Humira has long been the source of huge revenues for AbbVie – accounting for more than 50% of the company’s sales. In 2015, the drug’s sales were around $14 billion. But the main composition patent is set to expire in the crucial US market late this year, potentially exposing the drug to competition. AbbVie however, is confident that additional patents on antibodies and formulations will keep rivals off the US market until around 2020.
Sean Murray
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