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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 As part of its commitments the agency released draft guidance on pharmacovigilance for biologicals in December 2015 for public consultation.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.

Alternative designs for clinical switching studies

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). As part of the Food and Drug Administration’s (FDA) implementation of the BPCI Act, the agency published draft guidance on biosimilar interchangeability in January 2017 [2].

Endpoints to assess interchangeability for biosimilars

Potential alternative/additional endpoints to assess interchangeability were discussed by Dr Daniel F Alvarez at the US Drug Information Association’s Biosimilars Conference [1].

Use of PK as an endpoint for clinical switching studies

As part of the Food and Drug Administration’s (FDA) implementation of the Biologics Price Competition and Innovation Act of 2009, the agency published draft guidance on biosimilar interchangeability in January 2017 [1-2].  Based on this guidance, the clinical study design primary endpoints should be pharmacokinetic (PK)/pharmacodynamic (PD) ‘because these assessments are generally most likely to be sensitive to changes in immunogenicity and/or exposure that may arise as a result of alternating or switching’. PK can be used as a surrogate endpoint to detect the impact of clinically important immunogenicity that can affect efficacy/safety.

Challenges in implementing trials to prove interchangeability

In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). As part of the Food and Drug Administration’s (FDA) implementation of the BPCI Act the agency published draft guidance on biosimilar interchangeability in January 2017 [1].

EU report finds decline in pay-for-delay pharma deals

The European Commission (EC) published the 8th Report on Monitoring Patent Settlements. It covers the 107 pharmaceutical patent settlements concluded between originator and generic drug companies in 2016 and shows that pay-for-delay settlements continue to decline. Such settlements can contravene antitrust laws with originator manufactures paying-off generics companies to delay generics market entry. Pay-offs can be monetary, but may also include distribution or licensing agreements or restrictions.