Reports

Use of PK as an endpoint for clinical switching studies

Home/Reports | Posted 11/05/2018

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(FDA) implementation of the Biologics Price Competition and Innovation Act of 2009, the agency published draft guidance on biosimilar interchangeability in January 2017 [1-2].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

Home/Reports | Posted 04/05/2018

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 As part of the Food and Drug Administration’s (FDA) implementation of the BPCI Act the agency published draft guidance on biosimilar interchangeability in January 2017 [1].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

Home/Reports | Posted 27/04/2018

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

Home/Reports | Posted 20/04/2018

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

Home/Reports | Posted 06/04/2018

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

Home/Reports | Posted 30/03/2018

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

Home/Reports | Posted 23/03/2018

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].

Lack of confidence in biosimilars slowing uptake in the US

Home/Reports | Posted 23/03/2018

Lack of confidence is amongst the various obstacles causing slow uptake of biosimilars in the US.

Legal and promotional wars being waged against biosimilars

Home/Reports | Posted 16/03/2018

Several obstacles contribute to the slow uptake of biosimilars in the US, one of which is the legal and promotional wars being waged against biosimilars by originator companies.

Biosimilars pricing slowing uptake in the US

Home/Reports | Posted 09/03/2018

Researchers at Trinity Partners have identified three major obstacles that are slowing the uptake of biosimilars in the US. These include biosimilars pricing, legal and promotional wars being waged by originator companies, and the lack of confidence in biosimilars. In this article biosimilars pricing is discussed.

Obstacles to biosimilars uptake in the US

Home/Reports | Posted 02/03/2018

Biosimilars uptake in the US has been slow to say the least, but what are the reasons for this? Researchers at Trinity Partners have come up with three major obstacles to increasing uptake of biosimilars in the US.

Launch of biosimilars info for healthcare professionals

Home/Reports | Posted 23/02/2018

During the European Commission’s (EC) third workshop on biosimilars, which was held in Brussels, Belgium on 5 May 2017 [1], the EC launched its new information guide on biosimilars for healthcare professionals.

Building confidence in biosimilars

Home/Reports | Posted 15/02/2018

The third Multi-stakeholder Workshop on Biosimilar Medicinal Products included a session on ‘Building Stakeholder Confidence in Biosimilar Medicines through Evidence-Based Information Sharing’ [1]. The session focused on clinical experience of switching and clarifying definitions of ‘interchangeability’ between the US and the European Union (EU).

Collaborative approach to use of biosimilars

Home/Reports | Posted 09/02/2018

The importance of having a collaborative approach for the use of biosimilars was a topic discussed during the European Commission’s (EC) third Multi-stakeholder Workshop on Biosimilar Medicinal Products, which was held in Brussels, Belgium on 5 May 2017 [1].

TGA approves three biosimilars but fewer generics in 2017

Home/Reports | Posted 02/02/2018

Australia’s Therapeutic Goods Administration (TGA) approved fewer generics in 2017 (101) compared to 2016 (118). However, 2017 also saw a large proportion of new registrations of immunotherapies and human monoclonal antibodies, while the listing of new ‘first generic’ medicines triggered a statutory 16% price reduction under the Pharmaceutical Benefits Scheme (PBS). In addition, the agency also approved three new biosimilars.

National experience with public procurement of biosimilars

Home/Reports | Posted 26/01/2018

In the third Multi-stakeholder Workshop on Biosimilar Medicinal Products organized by the European Commission [1], it included a session on ‘Biological Medicines Access Mechanisms: Balancing Access and Freedom of Prescription’. The session was designed to explore whether the EU Public Procurement Directive is fit for purpose in benefitting patient access and safety, physician choice, security of supply and sustainability of an affordable healthcare system, including innovation in new medicines and availability of biosimilars.

EC workshop aims to improve access to biosimilars

Home/Reports | Posted 19/01/2018

With the aim of encouraging equitable and timely access to biosimilars in Europe, the European Commission (EC) held its third workshop on biosimilars in Brussels, Belgium on 5 May 2017 [1].

Establishing interchangeability for biosimilars in the US

Home/Reports | Posted 12/01/2018

The European Commission held a Stakeholder Event on Biosimilar Medicinal Products in Brussels, Belgium on 5 May 2017. During this event Dr Hans Ebbers of the Medicines Evaluation Board (MEB/CBG) in The Netherlands discussed how interchangeability for biosimilars is established in the US.

Interchangeability and switching study designs for biosimilars

Home/Reports | Posted 05/01/2018

In an information guide for healthcare professionals jointly prepared by the European Medicines Agency (EMA) and the European Commission (EC), interchangeability refers to the possibility of exchanging one medicine for another medicine that is expected to have the same clinical effect. In terms of biologicals, this could mean replacing a reference product with a biosimilar (or vice versa) or replacing one biosimilar with another [1].

Establishing interchangeability for biosimilars

Home/Reports | Posted 08/12/2017

Dr Hans Ebbers, Regulatory Project Leader of the Pharmacotherapeutic Group III at the Medicines Evaluation Board (MEB/CBG) in The Netherlands discussed how to establish interchangeability at the European Commission stakeholder event on biosimilar medicinal products, which was held in Brussels, Belgium on 5 May 2017.

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