Asif Mahmood have diverse leadership experience as a health services professional with signifi cant accomplishments in all aspects of pharmacovigilance, clinical development, medical affairs, regulatory affairs, primary health care, project management & international health programs. He have vast experience of working in diverse therapeutic areas including rare diseases, novel preventive & therapeutic vaccines, monoclonal antibodies, cardiovascular, oncology, neurology, nosocomial diseases, generic and OTC medicines. He is currently working as Disease Area Cluster Lead for Biosimilars & Drug Delivery Devices at Pfi zer. Currently Pfizer has the largest biosimilars portfolio in the industry that includes projects on Infl ammation, Oncology, Hematology, ophthalmology etc.His past experience includes working as Associate vice president PV and Therapeutic Area Head (Rare Diseases) for Sanofi Genzyme, working as Senior Director & Director for vaccines PV at Sanofi Pasteur, working as Medical Consultant for Apotex Inc Canada. Prior to joining industry, he has worked as Joint Executive Director for Pakistan Institute of Medical Sciences (PIMS), Registrar of the Post graduate medical institute PIMS and as Deputy Director General, Ministry of Health Pakistan.
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.