May 27 GEROPHARM took part in the symposium "Biosimilars on the basis
of insulin and its analogues: characteristics, problems and prospects".
The event was arranged as the part of the business programme of the
All-Russian conference with international participation "Team approach
in modern endocrinology" that was held in the Federal Almazov North-West
Medical Research Centre.
The session was attended by the Vice President of Strategic
Development of GEROPHARM Group Lola Maksumova, the Deputy Director of
Clinical Affairs Igor Shchemelinin, the Head of Preclinical Trials
Elizaveta Posysayeva, the SeniorRegulatory Affairs Manager Anastasia
Filippova and the Senior Biomedical Statistics Specialist Victoria
Lola Maksumova made a presentation on modern views and approaches to the development of biosimilar drugs. She discussed the place of biosimilars in general classification of drugs and stressed that the market share of biotechnological drug products is growing steadily. She noted the positive trend towards harmonization of the regulatory requirements to biosimilars and told about main stages of their development.
Elizaveta Posysayeva focused on the changes, related to preclinical trials of insulin analogues, which have occurred over the past two years in the regulatory acts. She noted that innovations have led to a deeper analysis of binding insulin and intracellular metabolic activity, stimulated by insulin, to receptors, as well as to elimination of the requirements to conduct comparative animal studies. She presented, designed in accordance with the regulatory requirements, methods of analysis in vitro and the results obtained for new insulin analogues Lispro and Glargine, for which GEROPHARM has already received a permission to conduct clinical trials.
Igor Semilinen paid attention to the discussion of common approaches to insulin clinical trials. He noted that GEROPHARM relies on the advanced European experience, including regulatory requirements imposed to the development of biosimilars abroad. He discussed the specifics of biological equivalence evidence, and gave examples of the conductedclamp studies which represent the "gold standard" for considering insulin pharmacokinetics and pharmacodynamics and the basis for evidence of biosimilar and original drug comparability.
Anastasia Filippova focused on the issues connected with pharmacovigilance and evaluation of immunogenicity of insulin products and their analogues. She noted that along with clamp studies, the study of immunogenicity is an essential component that helps to bring a drug to the market. She discussed the evolution of regulatory requirements to drugs immunogenicity, which have recently undergone significant changes.
Victoria Loseva told the audience about the use of methods of biostatistics in clinical trials, focused on insulin biosimilars. She noted that if clamp trials are concentrated on the study of pharmacodynamic properties, the data is obtained manually, which may cause the influence of random factors. However, it is possible to reduce their influence by using mathematical "smoothing" models.
Thus, GEROPHARM Group has a serious attitude towards the investment to insulin line on the basis of a full cycle principle. The company contributes to the development of insulin biosimilars by using international experience and applying the most modern approaches.