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Health

Cosmetics

Nutritional Supplements

Medical Divices

Generics

New Molecule

Vitamin Drugs

Biologic /

Bio-technological

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BIOLOGICAL OR BIOTECHNOLOGICAL DRUG

What is a biological drug?

Biological drugs are those whose molecules are larger and formed by proteins produced by alive organisms, whose production process is not by a chemical synthesis. Some of the main and more common categories are the following:

  • Insulins

  • Vaccines

  • Biotechnological drug

  • Interferons, among others

What is a biosimilar drug?

A biosimilar drug is any product of biological origin previously registered in Mexico and not patented. List of Biosimilar Drugs EXHIBIT 3 , which must comply with the local interchangeability tests for a biological drug.

Requirements:

Same from a medicine including validation of biotech detention of the API validation process of the biologic source.

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