Mylan's Herceptin biosim matches Roche original in safety, efficacy study


CHICAGO--Mylan is working to bring a biosimilar of Roche’s Herceptin to the U.S. market--and now, it has some data in hand that could help it do just that.

Mylan’s contender--MYL-14010--is comparable to Herceptin at treating advanced, HER-2 positive breast cancer when it comes to both efficacy and safety, according to results from a Phase III study that rolled out Friday at the American Society of Clinical Oncology’s annual meeting here.

In the trial, 69.6% of patients taking Mylan's copycat med experienced tumor shrinkage, with 64% responding to Herceptin. And 38% of patients on the Mylan drug experienced serious side effects, compared with 36% of those taking Herceptin.

It’s good news for Mylan, which is looking to break into the tiny club of drugmakers with FDA-approved biosims. While Mylan and partner Biocon have boasted Indian approval for their product since late 2013--in part thanks to a decision from Roche to quit trying to protect its patent--in the U.S., it’s only Novartis’ Sandoz and a team of Korea’s Celltrion and Pfizer’s Hospira that currently have regulatory green lights.

If all goes as planned for the generics powerhouse, it’ll get a shot at the $6.54 billion in sales Herceptin raked in for Roche last year. And meanwhile, the Swiss pharma giant has a pair of new products on its hands that it hopes can close the revenue gap: Tecentriq, a recently approved immuno-oncology standout, and ocrelizumab, a near-market candidate that’s poised to shake up the multiple sclerosis landscape once it gets an FDA go-ahead.

- read the release

Special Reports: Top 20 generics companies by 2014 revenue - Mylan | Top 10 best-selling cancer drugs of 2013 - Herceptin

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