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EMA accepts 2 Sandoz biosimilars for review

The European Medicines Agency accepted two Sandoz International GmbH biosimilars for regulatory review.

Sandoz is proposing to market a biosimilar of AbbVie Inc.'s Humira and Johnson & Johnson's Remicade, both of which are used to treat autoimmune disorders, such as rheumatoid arthritis.

Sandoz's application for adalimumab and infliximab is supported by phase 3 clinical data, and the Novartis AG unit plans to launch both biosimilars, plus three others, by 2020.

Sandoz International acquired the rights to infliximab from Pfizer Inc. in 2016 for the 31 countries forming the European Economic Area.