Sandoz starts late-stage trial of Humira biosimilar

Generic drug maker hopes to gain approval of biosimilar adalimumab

HOLZKIRCHEN, Germany — Drug maker Sandoz has started a late-stage clinical trial of a biotech drug used to treat autoimmune disorders, the company said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the start of a phase-3 clinical trial of biosimilar adalimumab. The drug is a version of AbbVie's Humira, used to treat rheumatoid arthritis, psoriasis and Crohn's disease.

"This latest advancement in our pipeline represents our unwavering commitment to expanding patient access to biologics, particularly in disease areas where there is a significant need for more treatment choices," Sandoz head of global biopharmaceutical and oncology injectables development Mark McCamish said. "We look forward to bringing a high-quality and affordable biosimilar version of adalimumab to individuals around the world living with psoriasis and other debilitating autoimmune diseases, such as rheumatoid arthritis."

The company said the trial would support its efforts to win regulatory approval for the drug in the United States and the European Union. The company also is developing biosimilar versions of Amgen's Enbrel (etanercept) and Roche's Rituxan (rituximab).


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