New Mexican Biosimilar Rules on Biosimilars Take Effect in Mexico

Monday, March 9, 2015

Source: FDA News

Mexican regulators laid out rules for older biosimilars registered prior to Oct. 19, 2011, when the country’s biosimilarity rules were first established, mandating that companies conduct clinical trials to prove biosimilarity.

Cofepris will determine what tests are needed to prove biosimilarity on a case-by-case basis. Trials will be approved via the same procedures that apply to drug products, and all reference products must be registered in Mexico.

The regulation, which took effect Feb. 9, affects about two dozen biosimilars, including one of Roche’s MabThera (rituximab), that were registered before Mexico’s biosimilarity rules were laid out. The companies affected have until Dec. 31 to present their tests to the agency.

These products are called “biolimbos,” since they haven’t undergone any review consistent with globally accepted standards for the approval of biosimilars, says Justin Duarte Piné, a lawyer and consultant with Dannemann Siemsen Advogados in Sao Paulo, Brazil.

Products registered since October 2011 have had to demonstrate biosimilarity.

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