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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).

EMA studying pharmacovigilance for biologicals and biosimilars

New pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010. The European Medicines Agency (EMA) is responsible for implementing the legislation. As part of its commitments the agency released draft guidance on pharmacovigilance for biologicals in December 2015 for public consultation. This guideline has since been finalized and came into effect in August 2016.

Full or modified clinical programme for biosimilars

Dr Elena Wolff-Holz, from the Paul-Ehrlich-Institut and Federal Agency for Vaccines and Biomedicines, and Chair of the Biosimilar Medicines Working Party at the European Medicines Agency (EMA), gave a presentation on EMA initiatives with respect to biosimilars at the 16th Biosimilar Medicines Conference in April 2018 [1], and as part of her presentation Dr Wolff-Holz discussed cases where a full or a modified clinical programme was required for approval of biosimilars.