Alexey Skripkin
BIOCAD, Russian Federation
Title: Postmarketing safety surveillance program results of the first Russian interferon beta-1b biosimilar
Biography
Biography: Alexey Skripkin
Abstract
The first Russian interferon beta-1b biosimilar was registered by CJSC BIOCAD in September of 2009 in the territory of the Russian Federation, and by the end of 2015 the exposure was 14 789 patient-years. BIOCAD initiated an intensive monitoring program. By the April of 2016 there were 1903 ICSR processed. The bulk of notifications, 58.5% (n=1115) was received by the company specialists: 805 notifications (42.3%) were received from the patients, 300 notifications (15.7%) – from the patient support team members, 10 notifications (0.5%) – from the healthcare specialists. There were 788 notifications (41.1%) received from the national regulatory authority (Roszdravnadzor). Additionally, BIOCAD has initiated a non-interventional observational study. 650 patients were included, at this stage the study database is being prepared for the final analysis. Most often the patients had injection site reactions (n=1256), general reactions (n=1189), as well as the nervous system reactions (n=383). There were 8 cases of injection site necrosis, that, taking into account exposure and intense monitoring, is a low value. 41 notifications on the lack of efficacy do not contradict the information about the drug product as about 25% of patients had no response. There were 8 reports of pregnancy. Four of them resulted in a birth of a healthy child, three were spontaneously interrupted (one in the stage of 5 weeks because of thrombocytopenia, two – in the stage of 14 weeks), one pregnancy still continues. Unexpected reactions have low levels of causality, new risks have not been identified. The received information confirms the known risk/benefit ratio.