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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].

Biosimilars development moving to Asia

Biosimilars manufacturing is moving to Asia with biosimilars developed in Korea contributing 43% of the global biosimilars value. This has been a quick expansion from the total share of 0% back in 2012.  As outlined in Mr Per Troein’s presentation [1] on how the landscape of biosimilars development is changing, Korea has now taken over from Europe as the leading location for biosimilars manufacturing, see Figure 1.

Developing biosimilars

Global pharmaceutical sales have grown 6.4% over the last five years to reach US$964 billion in 2017. Although the US still accounts for the major share of drug sales other markets are growing fast. In the period 2012−2017 the pharmaceuticals market in China grew at a rate of 10.2%, making it the second biggest market by sales, accounting for US$82 billion in 2017. Brazil also experienced a huge increase in sales with growth of 12.1% during 2012−2017.

Update on the biosimilar programme in the US

A legal framework for approving biosimilars in the US was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).