OCT attended and presented at this conference which was dedicated to biosimilars and generics in Russia during the Conference in Istanbul on September 18-20, 2012. The presentation was made by the Medical Writer Vladimir Chistyakov and Business Development Manager Natalia Salamova. OCT covered the following topics in their presentation, emphasizing these keypoints:
During the first day of this conference, specialists presenting discussed clinical trials with biosimilars and generics in different regions of the world, including Russia and CIS countries. The OCT presentation included quite interesting points on several aspects of generic and biosimilar products in Russia.
A lot of questions were raised as to the differences between the regulatory requirements for bioequivalence studies in Russia and Europe, which constitutes one of the crucial points when discussing clinical trials designs with potential clients from Europe, USA, and so on. There are some diversities as to the minimum number of healthy volunteers, the Cmax equivalence margins, investigational product assessment period, etc. Clinical trials regulatory aspects (the approval process, timelines, etc.) were also of interest for the participants of the conference: the required documents, the regulatory bodies reviewing the submission folder, the timelines for the approval of LECs and import license obtaining, etc. The biosimilars module sparked the interest of the auditorium, too. Designs of trials were discussed (comparable pharmacokinetics and pharmacodynamics effects of the biosimilar drug and originator product, comparable safety and efficacy of biosimilar drug and originator product, etc.)
A special issue to be considered was also pre-clinical studies (comparative, additional or no studies) with the investigational medicinal product (a biosimilar drug and a generic drug), which has to be kept in mind while finalizing the list of documents for clinical trial approval submission. Biosimilars are still presenting a controversial issue for the key market players, among which of the leading position are scientific doctors, pharmaceutical companies, and legislative bodies.OCT has experience in biosimilar and biobetter development in the fields of:
OCT has worked on biosimilars for some of the top-selling biological products. Several of the trials have led to drug registration at FDA and EMEA.
OCT dares to hope that the presentation was interesting and - what is more important - useful for the gathered companies at the conference, since it briefly covered the most essential aspects with regard to generics, biosimilar drugs, and clinical trials with these drugs in Russia. If you are planning a clinical trial for your generic or biosimilar product – you are more than welcomed to contact OCT Business Development Department!
The presentation can be found by following the