Biosimilar medicines are obtained after the 20-year granted patent has expired and the information within the original formulas become of public domain.

After four years of intense debate between the Ministry of Health, scientific societies, the medical community, patient associations and national and foreign pharmaceutical companies, the decree which regulates biotech drugs was signed, opening the door for biosimilars for the treatment of diseases such as cancer, arthritis and diabetes, between others.

The decree will allow patients to have therapeutic alternatives of equal quality and lower price and establishes three routes for obtaining registration of biosimilars, which are:

  • The “complete file route”: applicable to new drugs and clinical and pre-clinical tests with animals and humans should be included before approval.
  • The “route of comparability”: applicable to drugs that are not new, but not yet sufficiently known and should include results comparative studies between the biological drug and the biosimilar.
  • The “short route of comparability”: applicable to the known drugs with fully characterized chemical, where there is no need to repeat all experiments with animals and humans, but evidence of studies made to the drug to be produced must be provided.

The decree also establishes that, laboratories wishing to trade biosimilar medicines must have the certificate of Good Manufacturing Practices according to the established law.

The Ministry of Health established that new biosimilar medicines must comply with a set of 9 types of tests that would ensure drug quality and patient safety.

The decree enter into force only after the Ministry issues two important guides (immunogenicity and stability), and said entity will have twelve months to proclaim the same.