The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in cooperation with the Association of International Pharmaceutical Manufacturers (AIPM) has recently organised an international scientific and regulatory conference “Biotherapeutic medicines: regulatory challenges and current practices - approaches for harmonization is the first international expert meeting of its kind to take place at Moscow in Russia”. The aim of the conference was to enhance regulation of biotherapeutic medicines.

The event was held with the support and participation of the Ministry of Health of the Russian Federation, the Russian Federal Service for Healthcare  Supervision, the Eurasian Economic Commission, the State Duma Committee on Health Protection, and the Russian Academy of Medical Sciences.

Ahead of the conference, AIPM executive director Vladimir Shipkov said, "Due to the complex nature of biotherapeutic medicines, harmonized regulatory standards are needed to best serve the interests of patients and healthcare systems throughout our region. I hope this conference will contribute to the establishment of a regulatory system for biotherapeutic and biosimilar medicines in Russia based on global best practices and established  regulatory procedures.”

Biotherapeutic medicines are larger and more complex than chemically-synthesized small molecule medicines which are derived from living organisms, their characteristics and properties are typically dependent on that organism and manufacturing processes and conditions. These  medicines have benefitted more than 350 million patients worldwide in treating both widespread diseases as well as rare diseases. Because these medicines' complexity poses important new challenges for regulators, the conference focuses on challenges in manufacturing biotherapeutics, evaluation and registration of biotherapeutic and biosimilar products, immunogenicity and safety monitoring, interchangeability, and pharmacovigilance.

Eduardo Pisani, director general, IFPMA said, "Biotherapeutic medicines open new possibilities for medicines and offer cures for some diseases that were previously considered untreatable. With more than 200 biotherapeutic medicines now registered and many others in the pipeline, science-based, harmonized regulatory approaches are needed. This conference is an important platform for sharing regulatory best practices among leading Russian and international experts."

The leading experts from Russia, Belarus, Kazakhstan, Ukraine, the World Health Organisation (WHO), Health Canada, several European  national regulatory agencies, and industry participated in the conference. They discussed current challenges in regulating  biotherapeutic and biosimilar medicines and exchange best practices.