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International prescribing incentives for biosimilars

In October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) published a report that investigated, among other subjects, international prescribing incentives for biosimilars [1].

International supply side policies for biosimilars

A report published by the Canadian Agency for Drugs and Technologies in Health (CADTH) investigated how international supply side policies influenced the use of biosimilars [1].

International policies for interchangeability, switching and substitution of biosimilars

In its report into different international policies on the use of biosimilars, the Canadian Agency for Drugs and Technologies in Health (CADTH) investigated the issue of interchangeability, switching and substitution of biosimilars [1].

Canadian report into international policies for biosimilars

The Canadian Agency for Drugs and Technologies in Health (CADTH) has released a report that investigates different international policies on the use of biosimilars [1].

Sustainability of biosimilars in Europe

Biologicals accounted for US$277 (Euros 238) billion in sales globally in 2017 and are projected to reach US$452 (Euros 388) billion by 2022. Biosimilars are making up an increasing part of this total, with the European biosimilar market being the most mature. According to Research and Markets, the biosimilar market in Europe reached US$2 billion in 2017 and is expected to exceed US$9 billion by 2023, at a compound annual growth rate (CAGR) of 29% during 2017−2023.

Addressing uncertainty in biosimilarity

How to address uncertainty in biosimilarity was a subject discussed by Dr Patrick Lynch, Product Quality Reviewer at the US Food and Drug Administration (FDA) during the Drug Information Association’s Biosimilars Conference 2017 [1].

Lot selection and handling for biosimilarity

In his presentation on Expectations and Approaches for Demonstrating Analytical Similarity, Dr Patrick Lynch, Product Quality Reviewer at the US Food and Drug Administration (FDA) discussed lot selection and handling for biosimilarity at the DIA Biosimilars Conference 2017 [1].

Ranking and evaluation of quality attributes for biosimilarity

Ranking and evaluation of quality attributes for biosimilarity was a subject discussed by Dr Patrick Lynch at the US Drug Information Association’s Biosimilars Conference [1].

Analytical consideration in demonstrating similarity for biosimilars

According to the US Food and Drug Administration (FDA) guideline on ‘Scientific Considerations in Demonstrating Biosimilarity to a Reference Product’ [1], ‘FDA expects that first, a sponsor will extensively characterize the proposed product and the reference product with state‐of‐the‐art technology, because extensive characterization of both products serves as the foundation for a demonstration of biosimilarity’ [2].

Analytical similarity for biosimilars

Dr Patrick Lynch, Product Quality Reviewer at the US Food and Drug Administration (FDA), gave a presentation on demonstrating analytical similarity for biosimilars at the US Drug Information Association’s Biosimilars Conference [1].

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