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FDA approves first three generic versions of Novartis' Gilenya for relapsing multiple sclerosis

Published on 06/12/19 at 11:21am

The FDA has approved the first three generic versions of Novartis’ sphingosine 1-phosphate receptor modulator Gilenya (fingolimod) to treat adult patients for relapsing multiple sclerosis (MS).

The three applications were filed by Sun Pharmaceutical, Biocon and HEC Pharm.

Novartis’ branded product generated $3.3 billion in sales for the company throughout 2018. The company launched legal action in the same year against more than 20 generic drug firms in a bid to prevent generic competition entering the US market. It’s expectation that no such competitor products would reach the market by the end of the year led Novartis to raise its full-year performance projections for 2019 in October.

“Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA,” said Dr Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research. “Having access to affordable treatments is important for patients with conditions that require ongoing care. The FDA has a longstanding commitment to increasing patient access to lower-cost, high-quality generic medicines.”

Matt Fellows

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