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Late-Stage Trial to Test Biosimilar Psoriasis Treatment

Skin inflammation from psoriasis (National Cancer Institute)

Skin inflammation from psoriasis (National Cancer Institute)

The Sandoz division of the global pharmaceutical company Novartis started a late stage clinical trial of a treatment for psoriasis biologically similar to the therapy etanercept, marketed by Amgen and Pfizer as Enbrel. The trial is expected to support the company’s application for regulatory approval in the U.S. and Europe.

Biosimilars is the name given to biologic treatments that act in a comparable manner to biologics already approved by regulatory agencies. In the U.S., the Affordable Care Act — health care reform bill of 2010 — has a section called the Biologics Price Competition and Innovation Act that shortens the licensing path for biologics shown to be  highly similar or interchangeable with a product already approved by FDA.

Etanercept uses reengineered DNA to inhibit a protein that promotes inflammation produced by the tumor necrosis factor alpha gene, and implicated in autoimmune inflammatory disorders, such as rheumatoid arthritis where joints become inflamed and skin inflammation in psoriasis. The clinical trial, says Sandoz is testing the safety, effectiveness, and immune response of its product compared to etanercept in patients with moderate to severe chronic plaque-type psoriasis, the most prevalent form of the condition.

Sandoz says its biosimilar product was already subjected to preclinical and clinical testing that shows comparability to etanercept. Details about the locations of the trial or numbers of patients to be enrolled were not disclosed.

The company says it is already investing in manufacturing facilities to bring the complex product to market. Sandoz says it now has seven late-stage clinical trials testing five biosimilar molecules.

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Hat tip: FirstWord Pharma

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