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Sandoz Obtains Positive CHMP Opinion for Humira Biosimilar

Issue: July 2018

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Sandoz received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for its proposed adalimumab biosimilar for the treatment of all indications of its reference product, including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis, according to a manufacturer release.

“The positive CHMP opinion for our biosimilar adalimumab is an important milestone for the millions of patients looking to reclaim their health after an autoimmune disease diagnosis,” Richard Francis, division head and CEO of Sandoz, said in the release. “If approved by the European Commission, the introduction of our biosimilar adalimumab can help to expand access for those who need it most and give patients and doctors confidence in their chosen treatment option. Biosimilar adalimumab is backed by robust science, assured by manufacturing excellence and created with a deep understanding of customer needs.”

The committee based its decision on analytical, preclinical and clinical data, which demonstrated the biosimilar’s matching safety, efficacy and quality to adalimumab (Humira, AbbVie).

Sandoz received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for its proposed adalimumab biosimilar for the treatment of all indications of its reference product, according to a press release.

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The committee evaluated data from a randomized, double-blind three-arm parallel study that demonstrated the biosimilar’s pharmacokinetic bioequivalence to adalimumab, as well as the phase 3 ADACCESS study, which demonstrated matching efficacy and safety between the biosimilar and adalimumab among patients with moderate-to-severe chronic plaque-type psoriasis.

If approved by the European Commission, the treatment will be granted centralized marketing authorization valid in the 28 countries of the European Union. Countries that are not members of the EU but part of the European Economic Area — Norway, Iceland and Liechtenstein — are expected to make corresponding decisions based on the European Commission’s recommendation, according to the release.