On November 14 and 15, the LATAM 2018 Biosimilars Forum was held in Mexico City. The event brought together health authorities and company representatives, among others, to discuss advances in the development of biosimilar drugs in the region. It is expected that in the wake of the Forum, LATAM governments will take steps to facilitate the entry of biosimilars into the drugs market as a means to widen access to biologic medical products.

Renato Porto, Director of Sanitary Regulation at ANVISA, Brazil, and Julio Sánchez y Tépoz, Federal Commissioner of COFEPRIS, Mexico, were among the speakers at the event citing regulatory advances in biosimilars in the region. Renato Porto stressed the importance of understanding that the classification of a drug as a biosimilar should not imply the automatic designation of the product as interchangeable, but that the substitution should occur with the consent of the prescribing physician. In addition, they underlined the extreme importance of patient follow-up in generating monitoring data that will allow for conclusions on these drugs’ interchangeability.

The forum highlighted a need to widen out discussion on biosimilars so as to reach decisions and formulate public policies that benefit those patients who need newer treatments. It is expected that, based on these discussions and the exchange of experiences of the Regulatory Agencies of the region, LATAM countries will work to establish common lines of action with a view to regulating this market.