Journal of Pharmacovigilance

Postmarketing safety surveillance program results of the first Russian interferon beta-1b biosimilar

Conference Series LLC Joint International Event on 7^th Pharmacovigilance & Pharmaceutical Industry

August 22-24, 2016 Vienna, Austria

Alexey Skripkin

BIOCAD, Russia

Keynote: J Pharmacovigil

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 and 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 was 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.

Biography :

Alexey Skripkin, MD, graduated from Rostov State Medical University (Rostov-on-Don, Russia) in 2005. He passed Residency in Neurology in 2007 and Postgraduate Training Program in 2010 at the Moscow State Medical Academy, I M Sechenov, Moscow, Russia. He continues his neurological practice. He has 6 years of experience in pharmacovigilance, has passed a number of comprehensive pharmacovigilance and pharmacoepidemiology trainings from 2010 to 2016. He was a Neurolology Medical Affairs Manager at BIOCAD from 2010 to 2012. He is BIOCAD’s Qualified Person for Pharmacovigilance since 2010, and the Head of Drug Safety Department since 2013.

Email: skripkin@biocad.ru