New Biologics and Biocomparables Guidelines are effective in Mexico

May 3, 2012 7:37 AM

In Mexico, new guidelines became effective in April for the marketing authorization of biologics and biosimilars called “biocomparables”.

Decision Recourses, one of the well-known research and advisory firms for pharmaceutical and healthcare sector, distributed a press release, saying 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.

As we also mentioned in our article about Mexican Biosimilars Guideline, 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.

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.

“Although Mexico has only recently established formal regulatory guidelines for the approval of biocomparables, non-originator biologics have been on the market in Mexico for several years,” said Decision Resources Analyst Lulu Pickering.

For example, Probiomed already sells six non-originator biologics, including Kikuzubam (rituximab), which is Probiomed’s version of Roche’s Rituxan/MabThera (rituximab). Last month, just before the new biocomparables guidelines took effect in Mexico, Probiomed won a $14.4 million tender to provide Kikuzubam to the State Employees’ Institute for Security and Social Services. However, owing to their existing patents for Rituxan/MabThera, Roche remains engaged in litigation against Probiomed.

“Although Mexican authorities are working to update the country’s laws and regulations relative to biologics, the market will likely remain in flux as domestic manufacturers are forced to comply with new regulations and innovator companies are forced into litigation in order to protect their intellectual property rights,” Dr. Pickering said.

 

Source: Decision Resources press release

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