ScholarLens Back to search
2020•Generics and Biosimilars Initiative JournalRequires access

Biosimilars markets: US and EU compared

Author information unavailable

Open publisher page 3 citations

Abstract

Differences between the US and European regulatory processes can lead to differences in the time taken for biosimilar approval. The European Medicines Agency is in some cases quicker to approve biosimilar drugs and Europe has overall more approved biosimilars, whilst the US approved the first biosimilar in 2015. Whatever the market, there are a number of strategies that can be employed to help address patient and healthcare provider concerns, such as educational programmes. This paper provides some insights on these aspects.

About this research paper

What this paper is about

Differences between the US and European regulatory processes can lead to differences in the time taken for biosimilar approval. The European Medicines Agency is in some cases quicker to approve biosimilar drugs and Europe has overall more approved biosimilars, whilst the US approved the first biosimilar in 2015. Whatever the market, there are a number of strategies that can be employed to help address patient and healthcare provider concerns, such as educational programmes. This paper provides some insights on these aspects.

Why it matters

OpenAlex reports 3 citations for this work. Citation counts describe recorded attention and do not establish research quality.

Key contribution

A contribution statement is not available in the OpenAlex record.

Method / approach

Method details are not available in the OpenAlex metadata.

Main findings

Findings are not separately available in the OpenAlex metadata.

Limitations

Limitations are not available in the OpenAlex metadata.

Applications

Application details are not available in the OpenAlex metadata.

Available abstract

Differences between the US and European regulatory processes can lead to differences in the time taken for biosimilar approval. The European Medicines Agency is in some cases quicker to approve biosimilar drugs and Europe has overall more approved biosimilars, whilst the US approved the first biosimilar in 2015. Whatever the market, there are a number of strategies that can be employed to help address patient and healthcare provider concerns, such as educational programmes. This paper provides some insights on these aspects.

Key concepts: Biosimilar, Agency (philosophy), Business, Regulatory agency, European market, European union, Pharmacology, Medicine

Related papers

Related paper 1Related paper 2Related paper 3
Back to paper searchBrowse research topicsOriginal source
Biosimilars markets: US and EU compared — Research Paper | ScholarLens