In Russia, regulatory requirements for the development of biotechnological drugs may be reduced

Participants of the BRICS working group gathered in Mumbai, India, to delve into the study of competition in pharmaceutical markets. The discussion revolved around the proposal made by the Federal Antimonopoly Service (FAS) to revise regulatory requirements with the aim of boosting the competitiveness of new biosimilar drugs. As part of this discussion, the idea was also put forward to develop proposals to reduce barriers to access biological medicines in the BRICS markets and to create common regulatory instruments.

Deputy Head of the Federal Antimonopoly Service of Russia Timofey Nizhegorodtsev spoke at the meeting of the working group. He noted that biotech drugs are becoming a fast-growing class of therapeutic products. Thus, 159 such drugs are registered in Russia, 7 new original molecules were created directly in our country.

“The development and production of biotechnological drugs will help increase the level of availability of medicines for citizens. However, this process is multi-stage and complex, accounting for a significant portion of healthcare costs. Currently, there is a global trend towards simplifying regulatory requirements for their development, including in order to increase the competitiveness of medicines,” reports the FAS press service.

In this regard, the agency first proposes to study the validity of current regulatory requirements and the impact of modern regulatory practices on the competitiveness of new biosimilar drugs. “Then it is necessary to develop proposals to reduce barriers to access of biological medicines to the BRICS markets, as well as create common regulatory instruments,” the report says.

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