FDA approves first generic copies of Gilenya
The US Food and Drug Administration has approved three applications for first generics of fingolimod capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.
The FDA granted approvals of generic fingolimod applications to China-based HEC Pharm (HKG: 1558) and Indian drugmakers Biocon (BSE:532523) and Sun Pharmaceutical Industries (BSE: 524715).
The generics are copies of Swiss pharma giant Novartis’ (NOVN: VX) Gilenya, which generated sales of $829 million in the third quarter of this year. The company has lawsuits in hand protesting launch of generic copies.
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