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
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.