Why Pharmacovigilance Is Important for Biosimilars

Pharmacovigilance is an essential part of the assessment of both small molecular weight drugs and biologicals. ◇. In the EU all biologicals and biosimilars must ...

Pharmacovigilance 101: What is it and why is it important?

U.S. Physicians Overwhelmingly Support Current FDA Data Standards, Switching Studies for Interchangeable Biosimilars; Oppose Pharmacy Substitution of Non- ...

Comparative testing and pharmacovigilance of biosimilars

Furthermore, international standards are missing and materials and methods differ from laboratories making the comparison of results very difficult. Clinical ...

considerations for effective pharmacovigilance and EU regulation

The risk management plan for biopharmaceuticals (innovator and biosimilar drugs) should be based on strengthening ongoing pharmacovigilance ...

A Health-System Pharmacist's Guide to Biosimilars

cals and the importance of postmarketing pharmacovigilance to ensure the safe use of biosimilars. 5. Discuss the role of health-system pharmacists in making ...

Pharmacovigilance of Biosimilars: Global Experience and Perspective

Ongoing robust pharmacovigilance is critical in the monitoring, detection, and assessment of safety signals over the life cycle of every biologic. The ...

Pharmacovigilance of biosimilars: challenges and possible solutions

Post-marketing surveillance is essential to detect, assess and prevent adverse reactions of chemically synthesized small molecule drugs as well as ...

Science of Biosimilars | JCO Oncology Practice - ASCO Publications

A survey of physicians in specialty areas showed that between 54% and 74% held positive views of the safety, efficacy, manufacturing, and pharmacovigilance of ...

with biologics, including biosimilars, versus small-molecule drugs [3,6]. Robust pharmacovigilance is essential for facilitat- ing accurate ...

Biologics and biosimilars: role in modern pharmacotherapy and ...

Pharmacovigilance is needed to ensure that adverse events are quickly detected, reported and attributed to the correct product and manufacturer.

Selecting the best-value biosimilar in emerging countries

A sound national pharmacovigilance system is especially necessary for follow-on biologics that have not been approved in highly regulated markets and, therefore ...

Biosimilars - FDA

FDA approved biosimilars are safe, effective treatment options. Biosimilars may provide more treatment options, increase access to ...

Editorial: Biosimilar Suffixes Are Important for Pharmacovigilance ...

They noted that 431 (87%) of the 494 spontaneous AE reports submitted from 2017 to 2018 included the brand name, and the remaining 63 (13%) used ...

(PDF) Biologics and biosimilars: role in modern pharmacotherapy ...

As biologics and biosimilars are derived proteins they have immunogenic potential and risk of adverse events which cautions their use. Pharmacovigilance is ...

Like any innovative drug approval, a correct pharmacovigilance plan should be emphasized to protect the patients and increase the medical ...

Biologics and Biosimilars: Unique Considerations in ... - LinkedIn

As the use of biological and biosimilar drugs continues to grow, pharmacovigilance systems play a crucial role in monitoring their safety and ...

Managing Pharmacovigilance Challenges for Biosimilars

As the portfolio of commercially available biosimilars expands, the demand for robust pharmacovigilance (PV) systems intensifies. Unlike small ...

Pharmacovigilance for Biosimilars vs pharmacovigilance for generics

Further, a minor change in manufacturing process could have a significant impact on the safety profile of a biosimilar and this impact also ...

Pharmacovigilance Considerations for Biosimilars in the USA

Challenges and opportunities for product-specific safety surveillance of biologics in both the pharmacy and medical settings are identified and ...

Pharmacovigilance of biosimilars - Journal of Postgraduate Medicine

Moreover, the parenteral nature of the biosimilar agents could also affect their immunogenicity. These clinically important differences highlight that ...