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Building confidence in biosimilars

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

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

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

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

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

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

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

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.

Is a biosimilar forever or just for Christmas?

Dr Elena Wolff-Holz discussed the need for clinical studies and the evolution of biosimilars over time. During her keynote address at the biosimilar medicines conference in London, UK, Dr Wolff-Holz highlighted that the ‘need for clinical studies may depend on the size and complexity of the biological and the clinical indications sought. Some examples of this include:

The importance of EPARs

Dr Elena Wolff-Holz* discussed the importance of European public assessment reports (EPARs) at a major biosimilar medicines conference in London, UK [1].

Generics News Research General


Biosimilars News Research General