Attn.: El Comisionado Federal para la Protección contra Riesgos Sanitarios y Presidente del Comité Consultivo Nacional de Normalización de Regulación y Fomento Sanitario Mr. Alejandro Ernesto Svarch Pérez COFEPRIS Ref: COFEPRIS’ draft modifications of the existing biocomparable products guideline NOM-177-SSA1-2013 Dear Mr. Alejandro Ernesto Svarch Pérez, Please let me first introduce IGBA, the International Generic and Biosimilar Medicines Association. We are a global industry association, which strengthens cooperation between associations representing manufacturers of generic and biosimilar medicines from around the world. Adopting a patient centric approach, IGBA works to improve patients’ access to quality-assured, safe and cost-effective medicines by promoting competition and enabling innovation in the pharmaceutical sector. In many countries around the globe, the use of biosimilar medicines has triggered competition in the originator biologic medicines market, allowing for treatment cost-efficiency gains in the therapy areas in which they are used. However, the pre-requisite is a well-functioning biosimilars market to ensure broader, timely, stable, affordable and sustainable access to biologic therapies patient access. This encompasses increased efficiency of biosimilars regulatory frameworks, which are a key enabler of greater access to quality-assured biologic medicines. IGBA, therefore, welcomes the opportunity to comment on COFEPRIS’ draft modifications of the existing biocomparable products guideline NOM-177-SSA1-2013. It is acknowledged that biocomparable products developed and manufactured outside of Mexico can seek marketing authorization / licensure in Mexico based on biocomparability data that have been generated outside of Mexico, including all clinical biocomparability data. The present draft modifications introduce a novel requirement for the renewal of a biocomparable product marketing authorization, which – at the time of marketing authorization / licensure renewal - asks for additional clinical biocomparability / interchangeability data generated in Mexican subjects by authorized third parties in Mexico. We ask COFEPRIS to waive this novel requirement for renewal applications; to our understanding, a renewal application should not go beyond updating the initial dossier, e.g., manufacturing, product testing, or product safety updates. This is also in line with international regulations and avoids divergent international requirements. Convergence of requirements is paramount to support worldwide access to life-saving biological medicines. IGBA is happy to provide further scientific input as why local clinical data generation is not at all appropriate for biosimilar medicines. We thank you for your consideration. Yours faithfully, Suzette Kox IGBA Secretary General