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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 As part of the Food and Drug Administration’s (FDA) implementation of the BPCI Act, the agency published draft guidance on biosimilar interchangeability in January 2017 [2].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(FDA) implementation of the Biologics Price Competition and Innovation Act of 2009, the agency published draft guidance on biosimilar interchangeability in January 2017 [1-2].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 As part of the Food and Drug Administration’s (FDA) implementation of the BPCI Act the agency published draft guidance on biosimilar interchangeability in January 2017 [1].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. 

Interchangeability for biosimilars

Dr Daniel F Alvarez, Senior Director at Pfizer, gave a presentation on interchangeability for biosimilars at the Drug Information Association’s (DIA) Biosimilars Conference, which was held on 24−25 October 2017 in Bethesda, Maryland, USA [1].

Guidelines for biosimilars around the world

Biosimilar guidelines and regulations are being developed all over the world, as outlined by Huiguo Hu at the Biosimilars Europe Congress [1].

FDA approach to retrospectively naming biologicals

How the US Food and Drug Administration’s (FDA) is tackling retrospective naming of biologicals was an issue covered by Dr Kellie Taylor, Associate Director of the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research (CDER). Dr Taylor gave an update on FDA’s naming policies for biologicals, including biosimilars [1].

FDA approach to prospectively naming biologicals

During her presentation at the Drug Information Association’s (DIA) Biosimilars Conference, Dr Kellie Taylor, Associate Director of the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research’s (CDER), gave an update on FDA’s naming policies for biologicals, including biosimilars [1].

FDA update on naming biologicals

Dr Kellie Taylor, Associate Director of the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology at the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), gave an update on the agency’s naming policies for biologicals/biosimilars at the Drug Information Association’s (DIA) Biosimilars Conference, which was held on 24−25 October 2017 in Bethesda, Maryland, USA [1].