PAN AMERICAN HEALTH ORGANIZATION
On October 1, PAHO released the report “Strengthening the Regulatory System in the Americas. Lessons Learned from National Regulatory Agencies of regional reference“. The report reviews the status of the regulatory framework for Trastuzumab and Rituximab biosimilars in Latin America, and makes recommendations to the region’s regulatory authorities to harmonize standards and strengthen control of the production of these drugs. On the basis of this document, the national authorities will deepen the joint work to address a common regulatory framework that favors the interchangeability of biosimilars throughout the region.
The report points out that, although there is similarity with regulatory requirements because they follow WHO guidelines, the number of biosmilars approved in the region is comparatively low. Regarding the regional production of biosimilars, PAHO pointed out that Argentina, Brazil, Cuba and Mexico are the only countries in the region with the capacity to produce these drugs. The first three have active state support, while participation in production by the government is low. Rituximab Mabthera, approved by the regulatory agencies of Argentina, Brazil, Chile, Colombia, Cuba and Mexico, has biosimilars approved in these 6 countries. In contrast, in the case of the Trastuzumab developed by Roche, Herceptin, only has biosimilars approved in Brazil, Chile, Colombia and Cuba.
After observing the regional panorama, the report highlights the difference in sales prices between biosimilars and reference products which, having a similar pharmacological effect, the former are relatively cheaper. However, it stresses that the value chain of these products in the region is poorly controlled. To enable the scaling up of biosimilar production, the report recommends that national regulatory agencies harmonize their regulatory frameworks to allow the interchangeability of products throughout Latin America. In addition, it recommends using common approaches for the marketing authorization of biosimilars as well as their subsequent post-marketing surveillance.