Double whammy for Roche as FDA advisory panel backs biosimilars of Herceptin and Avastin
At its meeting yesterday, the US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously for recommending approval of biosimilars of two top-selling drugs from Swiss pharma giant Roche (ROG: SIX).
The ODAC recommended approval of proposed biosimilar of Herceptin (trastuzumab) from Netherlands-incorporated Mylan (Nasdaq: MYL) and India’s Biocon (BSE: 532523).
The committee voted 16-0 in support of eligible indications of the reference product, which include HER2-positive breast cancer in the metastatic and adjuvant settings. The branded product generated sales of $6.73 billion last year.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Biosimilars
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze