IFPMA 2014 interview series “What’s at stake for biotherapeutic products?”
Interview with Dr Fermin Ruiz de Erenchun, IFPMA Biotherapeutics Group Committee Chair & Global Head Biologic Strategy Team at Roche
In this interview, Dr Fermin Ruiz de Erenchun explains how access to biotherapeutic products, including biosimilars, and ensuring their quality, safety and efficacy will be important challenges in the future, namely in Latin America. Science-based regulatory standards for medicines, in alignment with World Health Organization (WHO) guidance, are essential to ensure patient safety, and implementation of these standards at the national level will be critical moving forward.
Biotherapeutics are typically derived from living organisms. They are made by genetically engineering DNA, and a high level of precision is required in the commercial manufacturing process to produce a consistent product each time. Every step we take in the production of these medicines requires highly controlled testing to ensure consistent quality, safety, and efficacy.
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) represents over 90 innovative pharmaceutical companies and associations around the world. Our industry’s almost three million employees discover, develop, and deliver medicines and vaccines that advance global health. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community improve the lives of people everywhere. For more information, visit ifpma.org.Learn more
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