While No­var­tis com­bats gener­ic on­slaught in the courts, FDA ap­proves first Gilenya copy­cats

While No­var­tis is bat­tling to weak­en the chal­lengers vy­ing to mar­ket copy­cat ver­sions of its block­buster mul­ti­ple scle­ro­sis treat­ment Gilenya — the US drug reg­u­la­tor on Thurs­day ap­proved a tri­fec­ta of the drug’s first knock­offs. When they will launch is an­oth­er ques­tion al­to­geth­er.

Known chem­i­cal­ly as fin­golimod, Gilenya was ap­proved by the FDA in 2010 for re­laps­ing-re­mit­ting mul­ti­ple scle­ro­sis. It gen­er­at­ed sales of about $2.4 bil­lion in sales in the first nine months of this year.

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