Clinical trials in the new regulatory environment
The second practical conference Marcus Evans "Clinical Trials in Russia and EAEU" took place on June 15-17 in Moscow. The event was devoted to the discussion of new regulatory environment as the impetus for further development of clinical trials.
The Deputy Director of Clinical Affairs Igor Shchemelinin presented the business case, focused on the experience of GEROPHARM Group in clinical trials. In his report he told about the main aspects of carrying out clinical trials of biosimilars on the basis of insulin drugs from the point of view of medical practice.
Igor Semilinen noted that biosimilars are a specific class of drugs, which defines the methodology of clinical trials. In particular, he concentrated on the specifics of bioequivalence evidence and also discussed the issues connected with analogue insulins of various action and the required amount of samples necessary for their studying. Special attention was paid to the existing standards for the trials in the sphere of pharmacokinetics, pharmacodynamics and biosimilars safety and immunogenicity.
The company is currently developing analogue insulins of new generation that will be produced on a full cycle principle in Russia: from substance synthesis to finished dosage form. GEROPHARM will become one of the first companies in the world to introduce to the market a full line of analogue insulins, including glargine, one of the top 10 best-selling drugs. The company is planning to introduce these drugs to the Russian market in 2018.