FDA approves first generics of Gilenya

The US Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than in men. For most people with MS, episodes of worsening function and appearance of new symptoms, called relapses or flare-ups, are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Gilenya is a widely used orally administered treatment option. The FDA granted approvals of generic fingolimod applications to HEC Pharm Co. Limited, Biocon Limited, and Sun Pharmaceutical Industries Limited.

Addressing the challenges related to developing generics and promoting more generic competition is a key part of the FDA’s Drug Competition Action Plan and the agency’s efforts to help increase patient access to more affordable medicines.