Post

Biocon India Receives US FDA Approval for Biosimilar

Biocon India Receives US FDA Approval for Biosimilar

India’s Bangalore-based Biocon Ltd is the country’s first company to have a “biosimilar” approved in the U.S. for Roche’s drug Trastuzumab, marketed as Herceptin, and used in treating certain breast and stomach cancers.

Biocon Ltd.

Kiran Mazumdar-Shaw, the company’s chairperson and managing director said, “This was the first biosimilar for Herceptin approved by the US FDA. It was a proud milestone for us because there are competitors, including Pfizer, Merck and Amgen, with deeper pockets and more experience in developing and selling biologics, which says a lot about what our scientists have done. It’s recognition that India has the skills to develop such complex molecules. It puts India on the global map of biosimilars.”

The biosimilar, which will be sold under the brand name Ogivri, brings Biocon a step closer to building a truly original bio-drug, or ‘novel biologic’ for various markets. Biocon already has two novel biologics—Nimotuzumab for treating head and neck cancer and Itolizumab for treating psoriasis—that it markets in India, added Mazumdar-Shaw.

Share

About Amritt

Who We Are

Small or big, your business will love our financial help and business consultations! We are happy when our clients are too… Actually, this is quite simple to achieve – because each time we help them in sorting out different accounting intricacies or save the day before filing the taxes, they are happy indeed! And so are we.   

We have over Twenty years of experience helping our clients succeed in India

Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Blog
Page
Dictionary
Comparisons
Capabilities
India Business Guide
Services
Private
Speaking
Insights
White Papers
News
Newsletters
Clients
Case Studies
Companies In India
Webinars
Presentations
Industries