MEXICO

On April 26, the General Health Council, through the Official Gazette of the Federation (DOF, in Spanish), published the 2021 Edition of the National Compendium of Health Supplies, which contains indications for trastuzumab. Also on May 3, the Secretariat of Health (SSa, in Spanish) enacted the emergency modifications to the regulation on drug interchangeability tests. The text modifies the Official Mexican Standard NOM-177-SSA1-2013 in terms of recognition in national territory of interchangeability tests and studies performed abroad. Both regulations are already in force. 

The National Compendium of Health Supplies indicates that trastuzumab can be applied as an injectable solution and that each vial with powder can contain 150 mg of the drug. In turn, it is indicated for breast cancer patients with the presence of the Her2Neu oncogene. For its part, it notes that trastuzumab emtansine is used for the treatment of locally advanced unresectable HER2-positive breast cancer or metastatic breast cancer, for patients who have received prior treatment with trastuzumab and a taxane.

The drug interchangeability regulations establish that in the event that drug interchangeability tests are performed in national territory, they must be carried out by Authorized Third Parties. If the drugs are manufactured abroad, those interchangeability or biocomparability studies carried out in the country of origin will be acceptable. It also establishes that the New Molecules Committee (NMC) may request the extension of preclinical tests of these foreign biotechnological products if it deems it pertinent.