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Biosimilar: Regulatory Update

Biopharmaceutical in United States: Biosimilar: Regulatory Update

Datamonitor
  • Publication date: August 2011
  • Report price: $ 395

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Summary

Table of Contents

Introduction

Across the globe, regulators continue to develop the approval pathways and guidance regarding biosimilars. In the US, the FDA is currently consulting with various stakeholders regarding details of the US biosimilars pathway. While in the EU, the EMA is furthering development of approval pathways for biosimilar monoclonal antibodies

Features and benefits

* Provides global biosimilar sales (2008–10), in addition to the status of biosimilar approval pathways across the globe.
* Insight into the key biosimilar regulatory developments in the US, EU and emerging markets

Highlights

Since the US biosimilars pathway leaves many of the details for approval up to the FDA, the regulator has sought consultation, with discussion focusing on user fees, interchangeability, comparative studies and exclusivity, among other issues.
In Europe, the European Medicines Agency (EMA) has been seeking to develop further guidance for more technically challenging products such as monoclonal antibodies, while UK regulatory authorities have given their backing for the use of number of biosimilars in the national health services of England and Scotland.
The Brazilian government has also shown willingness to embrace biosimilars in an effort to reduce ever-increasing government healthcare expenditure. However, in contrast, a number of biosimilars have been removed from the substitution list in Norway, following a court ruling.

Your key questions answered

* Evaluate the evolving regulatory environment around the world, and how this impacts biosimilar market access and uptake.
* Gain insight into the strategies employed by payers and pharmaceutical companies in response to these changes in the regulatory environment.

Datamonitor
  • Publication date: August 2011
  • Report price: $ 395

Get this report today!

$ 395 - 1 User License
$ 988 - Corporate License

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