Journal of Bioequivalence & Bioavailability

Polymeric prodrugs: Recent achievements and general strategies

International Conference and Exhibiton on Pharmaceutical Regulatory Affairs

6-7 September 2011 Baltimore, USA

Neeraj Agrawal

Scientific Tracks Abstracts: JBB

Abstract:

Background: Blastoferon? is a pharmaceutical product of interferon beta 1a currently marketed in Argentina and Latin America as a biosimilar to the innovator interferon beta 1a for the treatment of MS. Although regulatory requirements for biosimilars are on debate, there is consensus about the necessity to obtain evidence of the eff ectiveness of these drugs on clinical grounds. Th e aim of this study was to assess the clinical eff ectiveness of Blastoferon? from an open-label, multicentre, retrospective, observational, post-marketing study. Methods: We evaluated a cohort of all adult relapsing-remitting MS patients from 4 Latin- American centers that were treated with Blastoferon? for a minimum of 12 months. Baseline clinical and demographic data, relapses and EDSS scores during treatment were collected for analysis. Clinical outcome measures of eff ectiveness were the proportion of relapse-free patients, the progression of disability as assessed by EDSS score and the annualized relapse rate. Wilcoxon signed-rank test was used to compare relapse rate and EDSS score before and aft er interferon treatment. Results: Our cohort included data from 78 MS pat ients treated for a median of 25 months (range: 12-57). Th e median time of disease was 6 years (range: 1-33). Fift y-eight (74.3%) patients remained relapse-free during the period of treatment with Blastoferon?. Th e mean annualized relapse rate in the 2 years before treatment was 0.59 (95%CI: 0.49-0.68). Aft er 25 months of treatment, these fi gures drop to 0.15 (95%CI: 0.08-0.21). Th e drop in relapse rate was highly signifi cant (Wilcoxon signed-rank test: z=6.43, p<0.00001). Th e median EDSS score at treatment onset was 2 (range: 0-7.5), whereas the median of this score aft er treatment was 3 (range: 0-8.5). However, this diff erence was not signifi cant (Wilcoxon signed-rank test: z=0.95, p=0.34). Conclusion: Treatment of relapsing-remitting MS with Blastoferon? reduced the relapse-rate of the disease

Biography :

Dr. Marcelo Kauffman is a neurologist with MSc and PhD degrees in Molecular Biology. He has been the person in charge of the pre-clinical and clinical development of Blastoferon as an advisor of Bio Sidus S.A. Clinical Research Department. He has been the author of 5 papers presenting the results of the different pre-clinical and clinical Blastoferon studies. Currently, he holds the position of Chief of the Neurogenetic Clinic of Hospital JM Ramos Mejia in Buenos Aires, Argentina and is a lecturer in the School of Medicine of the University of Buenos Aires