Coherus BioSciences reveals positive outcome for biosimilar PK/BE study

Coherus BioSciences Inc. of Redwood City, California recently announced initial results from several current clinical pharmacokinetic bioequivalence (PK/BE) studies comparing two products, both developed for the purpose of addressing certain chronic arthritic and skin conditions.

The company is performing three concurrent research programs contrasting its own CHS-1420, a proposed adalimumab (Humira) biosimilar candidate to the brand drug Humira currently marketed in Europe.

Spokespersons reported that the first of its three studies demonstrated successful conformance to criteria for three specific endpoints or goals, including maximum serum concentration and two time-related standards. The research was performed as a randomized single-dose study in 216 individuals incorporating assessment of the CHS-1420’s tolerability and safety, according to company representatives.

Adalimumab (Humira) is used to reduce symptoms of moderately to severely active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and a chronic skin condition called hidradenitis suppurativa.

Additionally, the formulation can be indicated for certain patients with Crohn’s disease or ulcerative colitis whose conditions have failed to improve with previous treatment regimens.

Coherus markets several biosimilars, including three late-stage products developed for the treatment of cancer, autoimmune diseases and other critical conditions. The company also develops products for oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis (MS).

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Organizations in this story

Coherus BioSciences, Inc. 333 Twin Dolphin Dr Redwood City, CA 94065