Expert Consensus Recommendations on a Biosimilars Value ...

Results: The expert panel agreed on a biosimilar value framework for the GCC countries that is founded on trust, cost savings and contextual ...

The expert panel agreed on a biosimilar value framework for the GCC countries that is founded on trust, cost savings and contextual considerations.

(PDF) Expert Consensus Recommendations on a Biosimilars Value ...

Results The expert panel agreed on a biosimilar value framework for the GCC countries that is founded on trust, cost savings and contextual ...

A Multistakeholder Consensus on Challenges and Solutions to the ...

Biosimilars may serve as lower-cost options to biologic drugs and hold the potential to create a more sustainable healthcare system by making room for ...

Consensus-Based Overarching Principles and Recommendations ...

While being highly similar in quality, safety, and efficacy to biologic reference products, biosimilars can reduce the financial burden and ...

Expert Consensus Recommendations on a Biosimilars Value ...

Abstract Objective This paper aims to develop a biosimilar value framework with local stakeholders in Gulf Cooperation Council (GCC) countries.

Selecting the best-value biosimilar in emerging countries

The WHO has issued guidelines for the evaluation of biosimilars [3]. However, these guidelines are not mandatory. At present, biosimilar ...

A Systematic Literature Review of Gaps and Challenges in Value ...

In light of the comparability exercise approved by regulatory authorities, a price comparison is appropriate when biosimilar reimbursement is requested for ...

Guidelines on evaluation of similar Biotherapeutic Products (SBPs ...

A variety of terms, such as “biosimilar products”, “follow-on protein products” and “subsequent-entry biologics” have been coined to describe these products.

Demonstrating Value for Biosimilars: A Conceptual Framework

payers, providers, patients, regulatory guidance, biosimilar adoption and commercialization ... regulatory documents, and expert opinion on the develop-.

Winning with biosimilars - Deloitte

Washington DC: United States Food and Drug Administration, 2012. 2 World Health Organization. Expert Committee on Biological. Standardization. Guidelines on ...

A Systematic Literature Review of Gaps and Challenges in Value ...

The literature and value assessment practices of HTA agencies generally support the recommendation to carry out a price comparison when biosimilar reimbursement ...

Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs ...

In 2015, China's National Medical Products Administration (NMPA) issued technical guidelines for the development and evaluation of biosimilars ...

How to select a best-value biological medicine? A practical model to ...

Since approval of the first biosimilar in Europe in 2006, more than 70 biosimilars across multiple therapeutic areas have been licensed and ...

Party) and specialists in biosimilars (Biosimilar. Working Party). The review by ... in EU guidelines, as EU experts have been closely involved in the ...

A consensus statement on the use of biosimilar medicines in ...

Our recommendations are based on the premise that biosimilar medicines can be considered therapeutically equivalent to their reference brand and ...

Comparative overview for naming biosimilars between the regulatory...

Results The expert panel agreed on a biosimilar value framework for the GCC countries that is founded on trust, cost savings and contextual considerations. They ...

AB1584 CONSENSUS RECOMMENDATIONS ON THE USE OF ...

Background Biosimilars are highly similar to reference products and can help in reducing the financial burden and medication underutilization while still being ...

Capturing the holistic value of biosimilars in Europe – part 1

Key drivers of biologic access after biosimilar competition included increased biologic awareness (51%) and changes to prescribing guidelines ( ...

ASCO Policy Statement on Biosimilar and Interchangeable Products ...

The early uptake of these agents into clinical practice guidelines and pathways has been reassuring to some, but the complexity of dealing with ...