New Guidelines for Biotech Drugs Approved in Mexico

As of April 2012, the guidelines for biotech (biosimilars + biologics) drugs in Mexico have been approved. To avoid confusion with a class of drugs already on the Mexican pharmaceutical marketcalled similares (copies of small molecule generics that have notundergone bioequivalence testing), biosimilars in Mexico are calledbiocomparable biotechnological drugs, or biocomparables. Under the new guidelines, the approval for drugs in the future will be determined by information from clinical studies, and reviewed by each subcommittee, rather than just one.  

“It remains to be seen what the impact of the new approval guidelines will have on domestic pharmaceutical companies that have already been selling non-originator biologics in Mexico." It will be interesting to see what happens to the drugs that have been on the market for many years. How do you think this will impact biosimilars in the US? Want to learn more about biosimilars? Check out our brochure here.

At the Business of Biosimilars and Biobetters 2012, Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals will be presenting “The Future of Biosimilars in Specific Emerging Markets,” highlighting the state of biosimilars in Mexico, as well as other emerging markets.  For more information on this session and the rest of the program, download the brochure here.  If you’d like to join us in Boston, register today and mention code XP1786BLOG to receive 25% off the standard rate.

Share this article with your social network, just click below to share now!

Share |