New guidelines for approvals and renewals of biologics

January 12, 2015

On 9^th February 2015, the recently issued Mexican Official Standard Rule NOM-257-SSA1-2014 for Biologics (“NOM 257”) will enter into effect. This Standard Rule was published in the Federal Official Gazette on 11^th December 2014 by the Head of the Federal Commission for Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, by its initials in Spanish “COFEPRIS”).

NOM 257 emphasizes that key points to ensure safety, efficacy and quality of biologics are already regulated in other Mexican Official Standard Rules currently in effect, such as those for clinical trials and pharmacoviligance.

NOM 257 empowers the Assessment Subcommittee on Biotech Products (Subcomité de Evaluación de Productos Biotecnológicos, by its initials in Spanish “SEPB”) to (a) assess technical and scientific data in connection with clinical trials, approval or renewal of innovator biologics or follow-on biologics (biocomparables) and to (b) issue opinions to characterize biologics as innovators, reference products or biocomparables.

NOM 257 provides transitional provisions for the renewal of those marketing authorizations of biologics granted before the amendments to the Health Law Regulations for Biologics issued back in 2011 came into force. These provisions establish that:

• COFEPRIS will assess whether biologics refer to innovators or biocomparables
• Renewal applications for innovators will not require assessment by the SEPB.
• Renewal applications for biocomparables will require prior assessment by SEPB
  to identify the product of reference in order for applicants to submit
  the corresponding tests.

These provisions will be applicable only for those renewal applications submitted before 31 December 2015.

COFEPRIS, however, missed an opportunity to address the current uncertainty in respect of Regulatory Data Protection for Biologics as NOM 257 does not provide for guidelines in this regard. 

We will follow up closely and keep our clients updated on this matter.