BIO Comments on Mexico's Proposed Biologics and Biosimilars Regulations

Biologics are complex medicines that are manufactured using living organisms.  Due to their size and complexity, biologics are distinctly different from traditional small-molecule drugs.  Any pathway for the approval of biosimilar biologics must protect patient safety, recognize the differences between traditional small molecule drugs and biologics, and preserve incentives for innovation.  As the Mexican government looks to establish a pathway to market for biosimilar biological products, BIO offers the following important considerations to ensure patient safety, as well as continued innovation in the life sciences industry.