New Mexican Biosimilar Rules on Biosimilars Take Effect in Mexico

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.

The regulation is intended to clarify a 2013 regulation setting out tests and methods for drug interchangeability, including biosimilarity. That rule sparked fears that companies would see their biosimilars yanked from the market, Cofepris says.

The 2013 regulation partially addressed this topic, but there were gaps and questions, Piné says. Standard 257 provides time for manufacturers of biosimilars already on the market to carry out the necessary biocomparability tests and meet new safety, efficacy and quality requirements, he said.

Cofepris’ case-by-case approach to clinical testing will likely be an issue for industry, Piné says, noting companies prefer clear guidelines and rules to ad hoc analyses. Other issues that still need to be clarified include naming, labeling, substitution, extrapolation and pharmacovigilance programs. — Jonathon Shacat