Current Status of Biosimilars and Their Impact on Pharmacovigilance

As the market for biosimilars expands, a nuanced approach is needed to balance cost considerations with patient safety and pharmacovigilance efforts.

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 ...

Pharmacovigilance of biosimilars – Why is it different from generics ...

Like innovator biologics, biosimilars also require specialized and experienced pharmacovigilance personnel because of the complexity of safety data and ...

Biosimilar drugs: Current status - PMC

The expiry of patent protection for many biological medicines has led to the development of biosimilars in UK or follow on biologics in USA. This article ...

Pharmacovigilance and Risk Management for Biosimilars: Unique ...

However, biologics (other than blood products and vaccines) are relatively recent in origin and are well beyond the reach of many patients due to their high ...

In this report, the current state of the biologics market in the ... the impact of biosimilars on molecule volume and price are ...

An Overview of Biosimilars—Development, Quality, Regulatory ...

Following the approval of the first biosimilar drug (somatropin) in 2006 by the European Medicine Agency (EMA), the market of biosimilars has seen considerable ...

Why Pharmacovigilance Is Important for Biosimilars

So many factors have the potential to affect the quality and performance of biosimilars that clinicians must be aware of the need for ...

... pharmacovigilance activities, in the same way as for ... difference in the nature, severity or frequency of adverse effects between biosimilars and their.

Postmarketing Safety of Biosimilars: Current Status, Challenges, and ...

EMA and USFDA recommend attention on pharmacovigilance due to immunologic reaction and its reflection in a pharmacovigilance plan. Different ...

Biosimilars - FDA

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

Biological drugs, also known as first generation biopharmaceuticals, are being produced for the last 30 years and are in clinical use for a ...

Future Evolution of Biosimilar Development by Application of ...

Biosimilars are subsequent versions of originator biological drugs (“biologics”) that are highly similar to their reference product, and provide ...

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 ...

However, as of February 2019, only 17 biosimilars have been approved, with only 7 currently on the market. Of the few biosimilars currently available to ...

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 ...

A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine').

Based on the law and US FDA draft guidance on interchangeability,, a biosimilar designated as interchangeable “may be substituted for the reference product ...

Current state of biologic pharmacovigilance in the European Union

Although highly similar to reference products, biosimilars are not expected to be structurally identical. For these reasons, proper reporting of ...

Rationale, Opportunities, and Reality of Biosimilar Medications

Although the effect of biosimilars on health care costs is not yet clear, a recent analysis from the RAND Corporation estimates that the introduction of ...