Biography
Biography: Asif Mahmood
Abstract
Advances in biotechnology have ensured a world of opportunities for biosimilars to enter the market and serve the needs of patients in a cost-eff ective manner. However, pharmacovigilance and risk management for biosimilars present a significant challenge that arise from their unique characteristics as biologics as well as from their diff erences with the reference innovator products. Traditional PV processes may not incorporate suffi cient provisions to meet the particular requirements for biosimilars. While a biosimilar and its reference drug can show similar effi cacy, it can exhibit a diff erent safety profile with respect to the nature, seriousness, or incidence of reported Adverse Events (AEs). Therefore, there is a need to clearly identify the specific product associated with the AE. Hence, product naming is an important consideration for biosimilars traceability. The potential for immunogenicity represents an important safety concern with all biologics, including biosimilars. The nature and severity of immunogenic reactions may diff er from those observed for the reference innovator and immunogenicity data from the reference product may not be directly extrapolated to the biosimilar. Given the relatively small number/size of clinical trials required for regulatory approval of biosimilars, full characterization of the immunogenicity profi le of a biosimilar may not be established at the time of regulatory approval. Continued post-marketing surveillance of biosimilars is critical for eff ective risk management. Also, the unique nature of biosimilars requires a labeling approach that combines data on the reference product with data specifi c to the biosimilar due to diff erences in their source materials, manufacturing processes and impurities. Finally, the safety specifi cations in the RMP of a biosimilar should include the identifi ed and potential risks of the reference innovator product as well as risks identifi ed from studies on the specific biosimilar product.