Mexico issues regulations to approve biologic drugs

by Alejandro Luna

A decree was recently published modifying several provisions of the Health Law Regulations addressing the approval of biologic drugs. The main points of interest are:

– The provision included in the law stating that Mexico will allow for approval of follow-ons as “biocomparables” is regulated in more detail.

– Commonly, a biocomparable drug will make reference to a previously registered innovator drug. If the innovator drug has not been authorized in Mexico, a previously registered biocomparable drug can serve as reference.   The significance of this provision lies in that a biocomparable can be the first drug of its kind in our country, in the event that a developer delays a request for approval.

– Concerning prescription requirements, a provision states that prescriptions must contain the INN of the active ingredient. The commercial name is optional.

– Clinical trials for innovator biologics must take place in Mexico in all cases, when the drug will be manufactured in our Country.

– For drugs manufactured abroad, the Ministry of Health can request clinical trial to take place in Mexico, when considered necessary by a Biologic Products Committee (Subcomité de Evaluación de Productos Biotecnológicos)

– For the approval of biocomparable drugs, preclinical and clinical trials can be requested, according to what is determined by the Ministry of Heath, in specific rules to be further published.

– The regulations also state that the reach of biocomparability clinical trials will be supported by evidence of active ingredient characterization, and that, as such characterization improves;, the amount of required trials will decrease.

– An 8 year Bolar type exemption[1] is included concerning requests for approval of biocomparables when an innovator drug is covered by a patent.

– There is no indication of a Data Protection period.   This was to be expected, as Mexico still has not implemented Data Protection for chemical drugs.

– Once a project of authorization request for either innovators or biocomparables has been approved by the corresponding committee and submitted, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) has a 180 day period to decide on the application, with a possibility to issue a single requirement of additional information, which will have to be complied in 100 days. Upon expiration of these periods, applications will be understood as denied.

Although industry participants welcome these regulations, specific rules to approve biocomparables are still pending.

[1]This is a research exemption from patent infringement allowing a generic manufacturer to request a marketing authorization and perform the necessary studies for that purpose under the condition that the authorization will not be granted until after the patent expires. The term “Bolar” is used as reference to Roche Products v. Bolar Pharmaceutical, 733 F.2d 858 (Fed. Cir. 1984)

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