Reports
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].
Lack of confidence in biosimilars slowing uptake in the US
Lack of confidence is amongst the various obstacles causing slow uptake of biosimilars in the US.
Legal and promotional wars being waged against biosimilars
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
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
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
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
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.
