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

Related Articles:
Roche's Tecentriq bursts onto immuno-oncology scene, with Merck and BMS in its sights​
Roche looks ahead to immuno-oncology, MS to back up big-selling cancer meds
Biocon, Mylan plan appeals of Delhi court ruling on biosimilar​
Mylan, Biocon ready to roll out Herceptin biosimilar in India

Suggested Articles

Post-Tesaro buyout, don’t expect GlaxoSmithKline to spring for more commercial-stage oncology products anytime soon.

Already a fast-growing blockbuster, Novo Nordisk's injectable Ozempic won a major heart-helping FDA nod that could bode well for its oral sibling.

Bayer's new Vitrakvi for tumors with NTRK gene fusions is meeting skepticism in England and Germany, where cost watchdogs on Friday rejected it.