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Mexico gets ready to approve biocomparable drugs

By Alejandro Luna and

Juan Luis Serrano

Life Science IP Focus, 8th edition, Managing Intellectual Property 2010

Mexico's drug regulators are preparing to issue new rules on biocomparable drugs.

The scope of the regulations

• A definition of comparability tests between an innovator and a biocomparable drug;
• An indication that biocomparable drugs will use the same name for the active ingredient as the innovator;
• The General Health Law regulations at present contain a three-year period that provide a Roche-Bolar-like research exemption (related to the possibility to submit an application for marketing authorization before the patent expires, with an intent to launch after the date of expiry). This three-year period is eliminated, and a submission can now be made at any time. The modification in the corresponding article will also be applicable to chemical drugs;
• A provision indicating that when an innovator or reference drug is manufactured in Mexico, the preclinical and clinical trials must be conducted locally; and
• The timelines that COFEPRIS will have for approving both innovator and biocomparable drugs.

• A justification on the elimination of the three-year period in the Roche Bolar-like research exemption to verify compliance of provisions in the Industrial Property Law;
• Justification on each requirement to approve biocomparable drugs;
• Additional information on the cost implications that the new regulations will have for industry participants; and
• Additional information on the likely reductions in public health expenditures derived from the regulations.

• Concerning the Roche-Bolar-like exemption, AMELAF wants to change the wording in order for linkage review by COFEPRIS to be made only in regards to the first molecule (active ingredient) patent, which would be applicable both to biotech and chemical drugs. This goes directly against a decision by the Mexican Supreme Court, which interpreted linkage regulations to include patents covering pharmaceutical formulations as well. This specific proposal is very likely to be contended by AMIIF, and/or individual patent holders.
• AMELAF is also proposing to make most regulatory requirement for the approval of a biocomparable drug subject to the discretion of the Ministry of Health on a case-by-case basis. The present project contains mandatory pre-clinical and clinical trials, pharmacodinamics studies, immunity response studies in animals and in vivo studies. The proposal by AMELAF is to make all of these requirements applicable “if necessary”.
• Additionally AMELAF is proposing that the term for COFEPRIS to approve a biotech drug be reduced from 235 to 180 working days, and that, if that term expires without a response, then the application is deemed to be granted. This last item is not likely to be approved, as it could lead to the authorization of drugs without full review of the applications by the corresponding authority, which might generate sanitary risks.

• A note stressing that tests for follow-on drugs must be limited only to those strictly necessary to prove comparability in safety, quality and efficacy, to avoid high development costs.
• ANAFAM also provides arguments in favour of the removal of the time limit in the research exemption, citing as examples similar provisions in the US and Switzerland. They also recommend that the provision should be interpreted in the sense that a marketing authorization for either a generic chemical or a follow-on biologic drug should be granted immediately after the first active ingredient patent expires, regardless of further patents for polymorphs, formulations or uses.
• ANAFAM is requesting a removal of the obligation to hold pre-clinical and clinical trials locally when a drug will be manufactured in Mexico, on the grounds that this would inhibit business development.

The present system

The need for incentives