New biologics and biosimilars approval guidelines in Mexico

In Mexico, new guidelines are now in effect for the market authorization of biologics and biosimilars, which are called “biocomparables.” A report from health care advisory firm Decision Resources finds that biotech drugs, which include both biologics and biosimilars, are defined in Mexico as drugs that are produced by molecular biotechnology and have pharmacological activity.

To avoid confusion with a class of drugs already on the Mexican pharmaceutical market called similares (copies of small-molecule generics that have not undergone bioequivalence testing), biosimilars in Mexico are called biocomparable biotechnological drugs, or biocomparables. The Mexican guidelines for the approval of biotech drugs became effective in April 2012.

Decision Resources’ The Mexico: Market Access Tracker service finds that the newly established Subcommittee on Evaluation of Biotechnology Products will set guidelines on a case-by-case basis regarding clinical studies that are required for regulatory approval of biotech drugs. This subcommittee reports to Mexico’s Committee on New Molecules, which is responsible for the regulatory approval of biologics and biocomparables. The operating rules for both committees became effective in February 2012.