New Biotech Regulations (April 2012)

As many other emerging economies, Mexico is going through what is known as epidemiological transition. With the improvement of quality of life for the majority of the population, and the growth and consolidation of a more educated middle class, infectious diseases and other health issues related to poor hygiene and inadequate urban conditions are receding, while chronic and degenerative diseases, related to the increase in life expectancy and the aging of the population are gaining terrain.

This phenomenon, together with the fact that patent protection for many important biological drug products is running out, brings for Mexico the opportunity and the challenge of a new market of biological “generics”, also known as Similar Biotherapeutic Products.

As one of the most promising developing economies, Mexico has taken the lead and created regulations specifically for registration of Similar Biotherapeutic Products. In this infograph, a summary of the global and Mexican history of regulations for biotech products:

Biotech regulations mexico global

Summary of the new regulation:

  • Definition of biocomparability
  • Preclinical and clinical studies to evidence comparability
  • 12 years from submission of patent of reference – request authorization to start studies and tests
  • New Molecules Committee: Biotech Products Evaluation Subcommittee
  • Labeling: MB (Medicamento Biotecnológico) or MBB. (Medicamento Biotecnológico Biocomparable) + INN
  • Prescriptions: INN mandatory, proprietary name optional
  • Pharmacovigilance requirements
  • Local clinical studies (innovative or biocomparable) might be requested
  • Inmunogenigity studies and adverse effects reports – in the case of biocomparables, to evidence comparability
  • For biocomparable products: toxicology tests in animals, characteristics of pharmacodynamic studies and minimum requisites of comparative clinical studies are detailed
  • Specific requirements set on a ‘case by case’ basis, and then defined for INN
  • The better characterization and physic-chemical comparability evidence, the less clinical evidence will be required

Last revision: October 2013


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