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Volume 9, Issue 5 (Suppl)

J Bioequiv Availab, an open access journal

ISSN: 0975-0851

Pharmacy & Biopharma 2017

August 31-September 01, 2017 Philadelphia, USA

August 31-September 01, 2017 Philadelphia, USA

International Conference on

Biopharmaceutics and Biologic Drugs

International Pharmacy Conference

J Bioequiv Availab 2017, 9:5 (Suppl)

DOI: 10.4172/0975-0851-C1-031

Biosimilars: Challenges in safety and risk management

Asif Mahmood

Pzifer, USA

dvances in biotechnology have ensured a world of opportunities for biosimilars to enter the market and serve the needs

of patients in a cost-effective 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 differences with the reference

innovator products. Traditional PV processes may not incorporate sufficient provisions to meet the particular requirements

for biosimilars. While a biosimilar and its reference drug can show similar efficacy, it can exhibit a different 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 differ 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 profile of a biosimilar may

not be established at the time of regulatory approval. Continued post-marketing surveillance of biosimilars is critical for

effective risk management. Also, the unique nature of biosimilars requires a labeling approach that combines data on the

reference product with data specific to the biosimilar due to differences in their source materials, manufacturing processes and

impurities. Finally, the safety specifications in the RMP of a biosimilar should include the identified and potential risks of the

reference innovator product as well as risks identified from studies on the specific biosimilar product.