Biologics and Biosimilars

Biography

Biography: Ricardo Ibarra-Cabrera

Abstract

Biopharmaceuticals represent a very promising option for treating the most challenging diseases; nevertheless, there is no budget in the world that could effectively provide universal healthcare with a purely innovative drugs portfolio.Biosimilars represent a lower cost alternative for public healthcare systems. For instance, subsequent versions of recombinant erythropoietin with price reductions of up to 90% were launched in Mexico in 2006, and 82% cheaper rituximab versions entered the market later, among many others. Such products were originally registered as traditional generics in Mexico, but now that the regulatory framework for biosimilars is complete and well established by the Official Norm NOM-257-SSA1-2014issued in December 2014, local manufacturers face a great challenge. They need to perform some or most of the required studies for demonstrating their products’ safety, quality and biocomparability within eight months in order to renew their sanitary registration. Unfortunately, some of them cannot be fully done in Mexico due to lack of R&D infrastructure. Therefore, the biosimilars industry is at a crucial time in the country now that the Government is eager to have low-cost medicinesbut at the same time has developed more strict regulations for them. This all represents many business opportunities for laboratories, distributors and biotech companies who are willing to make quality their competitive advantage, as well as the possibility for patients to haveimproved access to safer and more efficacious treatments.