Reports
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 As part of its commitments the agency released draft guidance on pharmacovigilance for biologicals in December 2015 for public consultation.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 As part of the Food and Drug Administration’s (FDA) implementation of the BPCI Act, the agency published draft guidance on biosimilar interchangeability in January 2017 [2].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(FDA) implementation of the Biologics Price Competition and Innovation Act of 2009, the agency published draft guidance on biosimilar interchangeability in January 2017 [1-2].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.
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].
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].
