Economy

Mylan Gains FDA Approval for Generic Copaxone

Mylan Gains FDA Approval for Generic Copaxone

Mylan said the drug is very popular in the US, adding in its statement that the 20 mg version has brand sales of about $700 million and the stronger 40 mg dose a brand size of $3.64 billion.

Shares of Natco Pharma gained 20 per cent to hit the upper circuit of Rs 954.35 on Wednesday after its partner Mylan received the U.S. regulator's approval for the generic version of multiple-sclerosis treatment drug Copaxone. The generic version is coming to a market of about 400,000 U.S. patients with MS - 85% of whom suffer from a relapsing form.

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The FDA approved both doses - 20 mg and 40 mg - of Mylan's version of Teva's Copaxone, which generated global sales of $1.02 billion in the second quarter of this year.

"Mylan has invested tens of millions of dollars over many years to bring this medicine to market", CEO Heather Bresch said. Importantly, Copaxone is AP rated (or therapeutically equivalent and substitutable), which makes it easier to switch existing Copaxone patients to the generic. "Our commitment to the MS patient community extends beyond bringing generic versions of these products to market". The program includes a mobile app, in-home injection training, a round-the-clock support center, MS nurse support and co-pay assistance. "/" Class="local_link" >(NASDAQ:MYL) shot up 17.59% in NY on the back of Food and Drug Administration (FDA) approval news. The formal decision is pending FDA ruling. The potential generics represent a total of $92.5 billion in annual brand sales, according to QuintilesIMS. Also, Mylan may be eligible for 180-day exclusivity of this product, though the FDA did not indicate other entrants (namely Momenta/Sandoz) would not be able to also enter the market. Currently, one out of every 13 prescriptions filled in the US - brand-name or generic - is a Mylan product.


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