Managing Pharmacovigilance Challenges for Biosimilars

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

Pharmacovigilance and Risk Management for Biosimilars: Unique ...

This paper focuses on pharmacovigilance (PV) and risk management for biosimilars, the issues and challenges faced in monitoring their safety and possible ...

Pharmacovigilance Challenges for Biosimilars - LinkedIn

The following insights data were collected by International Pharmacovigilance Professionals who gathered during the event of Biosimilars ...

Pharmacovigilance & risk management for biosimilars - Labcorp

Post-approval pharmacovigilance is extremely important for biosimilars due to the nature of conditions they treat and the fact that fewer ...

Pharmacovigilance considerations for biologics and biosimilars

Pharmacovigilance challenges: There are unique challenges with safety and ... Additional risk management measures for biosimilars can address risks ...

Barriers towards effective pharmacovigilance systems of biosimilars ...

Inconsistencies in biosimilar nomenclature make it difficult to adequately trace drugs and record adverse drug reactions associated with their ...

Current Status of Biosimilars and Their Impact on Pharmacovigilance

Challenges in Adoption and Impact on Pharmacovigilance ... The push for enforced substitution of biologics with biosimilars has ignited a ...

The risk management plan for biosimilars should focus on heightens the pharmacovigilance measures, identify immunogenicity risk and implement special post- ...

Pharmacovigilance of biosimilars: challenges and possible solutions

Challenges are encountered during the pharmacovigilance of biosimilars, including traceability. These challenges and possible solutions were presented at the ...

Addressing and Overcoming Challenges in the Use of Biosimilars

In addition, multiple products may be difficult for providers to manage. If 1 reference product now requires 2, 3, or more biosimilars to meet payer formulary ...

Why Pharmacovigilance Is Important for Biosimilars

Clinicians and investigators should be aware of how they can improve pharmacovigilance for biosimilars, according to a report by ...

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 ...

a status update and the impact on pharmacovigilance

In terms of pharmacovigilance for the pharmaceutical companies for both innovator biologics and biosimilars, an advanced pharmacovigilance system needs to be in ...

Safety considerations include immunogenicity, hypersensitivity reactions, and an increased risk for other adverse effects.

(PDF) Pharmacovigilance and biosimilars: Considerations, needs ...

Expert opinion: The availability of biosimilars as lower-cost biologics must carefully consider issues of safety, efficacy and traceability.

Pharmacovigilance of Biologics in a Multisource Environment

We examined the frequency and thoroughness of how current pharmacovigilance systems attribute adverse events to biologics, including particular biosimilars, and ...

pharmacovigilance measures to manage any potential risk. In cases where clinically relevant immunogenic responses have been observed. (e.g. epoetins) ...

Pharmacovigilance and biosimilars: considerations, needs and ...

Expert opinion: The availability of biosimilars as lower-cost biologics must carefully consider issues of safety, efficacy and traceability.

The challenge of biosimilars - ScienceDirect.com

Switching biosimilars should be considered a change in clinical management. Regulatory guidelines have been established for some biosimilar categories but, ...

Ongoing Challenges in Pharmacovigilance | Drug Safety

The field's remit is broad, though its origins are in drug safety surveillance to monitor the adverse effects of medicines [2]. Today, the scope ...