Dear Sirs:

I would like to inform you that on September 15, 2023, the MODIFICATION of the Official Mexican Standard NOM-177-SSA1-2013 was issued, which recognizes bioavailability and bioequivalence studies carried out abroad within the health registration processes of generic medicines and biosimilars before Cofepris, in compliance with international guidelines.

RELEVANT. For biocomparable, biotechnological medicines that present clinical studies carried out abroad, they must present clinical studies carried out in Mexico in the extension or renewal of the health registration.2. This modification comes into effect as of September 16, 2023.

This is an excellent opportunity to enter the Mexican market, given that they eliminate one of the most important regulatory obstacles, which was the requirement to carry out clinical studies in the Mexican population to apply for health records for generic and biosimilar medicines.

This, combined with the already established government fast track benefits that allow the health registration application processes to be expedited when in the middle of a public tender or direct sale to a public health entity.

ARUNAMEX with all team, is prepared to take on your interests and organize your documentation in order to submit at Cofepris.

Do not hesitate to contact us if you have any questions about the aforementioned.

CAROLINA QUINTERO

ARUNAMEX S.C

COUNTRY MANAGER MEXICO.