BIO Comments on Peruvian Biologics and Biosimilars Regulations

BIO commends the Government of Peru for its endeavor to create a pathway for the approval of biological and biotechnological products. Peru is a growing market for biotechnology products and with the implementation of the US-Peru TPA, it promises to become an even bigger market. BIO takes this opportunity to express its general views on the regulation of biological products and believes that it is critically important to ensure that patent safety is not compromised and that incentives for innovation are preserved.  Please find links to the following below: BIO’s Full Comments (in English and Spanish) and DIGEMID Cover Letter.