Legal And Strategic Questions Surrounding Biologic And Biosimilar Litigation

• Published date: 26 August 2022
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Biotechnology & Nanotechnology
• Law Firm: OLIVARES
• Author: Karla Olvera and Ingrid Ortiz

Regulatory background in Mexico

The first time that biologics were officially recognised in the applicable legislation, the General Health Law, was in June 2009, with the inclusion of article 222bis defining a 'biologic/biotechnological product' as any substance that: has been manufactured by molecular biotechnology; has therapeutic, preventive or rehabilitative effects; is provided in a dosage form; and is identified as such by its pharmacological activity and physical, chemical and biological properties.

In October 2011, the Health Law Regulations were amended to establish the requirements to approve biologics and biocomparables (also known as biosimilars) - an area that was previously poorly regulated.

In 2012 a Mexican Official Standard Rule (NOM) was enacted to provide further clarity and certainty on the related regulatory process: Mexican Official Emergency Standard Rule NOM-EM-001-SSA1-2012.

After several amendments and other versions of the NOM, currently, the main legislation for this type of product, besides the General Health Law and its regulations, is NOM-257-SSA1-2014 concerning biologics (NOM 257), which was published by the Federal Commission for Protection against Sanitary Risk (COFEPRIS) in the Official Gazette. NOM 257 essentially outlines key points to ensure that the safety, efficacy and quality of biologics are already regulated in other NOMs, such as those concerning clinical trials and pharmacovigilance.

Prior to the entry into force of the amendments to the General Health Law that gave recognition to biotechnological drugs, and during the subsequent period in which the legal framework was not yet defined or completed for the regulation of those medicines, COFEPRIS granted some marketing authorisations for non-innovative biotechnological medicines that were not properly classified as biosimilars according to the relevant criteria to guarantee their quality, safety and efficacy when compared to the reference medicine requirements and international health standards; hence, non-innovative biotechnological drugs that were processed and/or granted prior to the formation of the corresponding legal framework and pending classification as biosimilars were known colloquially as 'biolimbos'.

Owing to the above, one of the main objectives of NOM 257 was that all the non-innovative biotechnological drugs identified as biolimbos would be submitted to a new review process that would prove that those drugs have the required quality, safety and efficacy characteristics.

However, this regularisation procedure was not duly observed, so today there are some biocomparables that have never met the quality, safety and efficacy requirements established by current health legislation, in the terms indicated by NOM 257, and that consequently fail to comply with the new specifications for biocomparability studies and tests and the pharmacovigilance processes necessary to protect and guarantee the health of patients.

On 31 May 2021, the Ministry of Health issued a decree in the Official Gazette amending several articles of the Health Law Regulations. Among other things, the most relevant points of this decree for biologics were the following:

• Regarding the approval of biocomparable medicines, the participation of the Subcommittee for the Evaluation of Biotechnological Products was eliminated, and an opinion of the New Molecules Committee is now sufficient.
• Clinical studies in...