GEROPHARM at the congress "Man and medicine"
GEROPHARM Group participated in the symposium on the development of modern drugs intended for the treatment of socially important diseases. The event was held as a part of the business program of the XXII Russian National Congress "Man and medicine" (April 11-14, Moscow).
The session was chaired by the President of the Union of Associations and Enterprises of the Medical Industry, the Chairman of the RSPP Commission on the Pharmaceutical and Medical Industry Yuri Kalinin, the Director of the Department of Pharmaceutical and Medical Industry of the Ministry of Industry and Trade Olga Kolotilova and the Head of the Ethics Committee of the Ministry of Health Aleksandr Chuchalin.
The event gathered the doctors with different fields of expertise together – endocrinologists, allergologists, therapists, pharmacologists, doctors of clinical laboratory diagnostics and others, and also the pharmaceutists in order to inform about the program of pharmaceutical and medical industry development for 2017-2020 and recent achievements in the field of drug development.
The Deputy Director of Clinical Affairs of GEROPHARM Group Igor Shchemelinin participated in the session. In his report he told about the real experience of the company in the research and development of biosimilars for the treatment of diabetes, where insulin lispro is used as a drug. The drug development was carried out in the framework of the Federal Target Program of the Ministry of Industry and Trade. Igor stressed that GEROPHARM had became a kind of "pioneer" in this field and had experienced substantial difficulties connected with the absence of regulatory framework, infrastructure for conducting clinical trials, research workers and relevant equipment.
Best European practices, including regulatory requirements for developing biosimilars abroad, were taken as the basis by GEROPHARM. Igor noted that in order to demonstrate the efficiency of biosimilars, it is necessary to confirm that both analogue and original insulin have similar pharmacodynamic and pharmacokinetic properties, and provide the proof of its safety, including the assessment of immunogenicity.
Clamp studies are the gold standard that helps to determine the pharmacodynamic and pharmacokinetic properties in insulins. Today GEROPHARM has a permission to carry out 5 similar studies, and a number of agreements with leading research centers, which are specially equipped for conducting trials, are signed. The staff of the company and the leading researchers were trained abroad – in top centers of the USA where they got acquainted with the innovative methods of conducting similar trials.
Today the company’s pipeline includes a full line of insulin analogues - lispro, biphasic lispro, glargine, aspart, degludec. The development is conducted in accordance with the international standards. The company plans to introduce these drugs to the market in 2019.