Wednesday, July 25, 2012

India unveils Draft of Biosimilar Guidelines

The government of India made a surprising announcement during the Biotechnology Industry Organization (BIO) international meeting June 18-21, 2012 in Boston MA.  BIO is the annual meeting of biotechnology leaders from across the globe.  With the Supreme Court upholding the Affordable Care Act (ACA) of 2010 just days after the convention it was appropriate that India unveil its guidelines for biosimilar development at BIO 2012. The ACA included the Biologics Price Competition and Innovation Act that allow the development of biosimilars.

The guidance document released by India is entitled “Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India” and outlines the biosimilar development procedures for Indian biopharma and global players. Here is a link to the guidance documents. India is now open for business in terms of international development and commercialization of biosimilars. The guidelines allow for India to be a part of the regulated global market currently developing biosimilars. Many hope that when the US FDA finalizes the guidances for biosimilars the market will begin to grow and develop. These guidances also assure global biopharma companies that India is developing standards similar to those already established in biotherapeutic development.

What are your opinions of the guidelines as the have been released?  How do you think these guidelines will affect global biopharma development?  Do you think India will be view as potential partners or competitors to the more established biotherapeutic markets?

For more information on this topic, check out the presentation by ShinJae Chang, VP, R&D, Celltrio titled "The Strategy and Case Study of Global Biosimilar Development" at the 13th Annual Business of Biosimilars and Generic Drugs.  For more information on this session and the rest of the program, download the brochure.  If you'd like to join us in Boston for the event, register today and mention code XP1786BLOG to save 25% off the standard rate!

Do you see reglation of biosimilars coming soon to the US market? Why or why not?

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