Biosimilar: Regulatory Update

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.

Global Biopharmaceutical Industry

Executive Summary
Introduction
Strategic scoping and focus
Key findings
The US moves closer to a biosimilars pathway
Biosimilar regulatory developments in Europe and the rest of world
Related reports
GLOBAL BIOSIMILARS MARKET SIZE
Biosimilars definitions
Biosimilar sales during 2008–10
Biosimilars approval pathways
THE US MOVES CLOSER TO A BIOSIMILAR PATHWAY
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FDA public meeting considers the pathway for biosimilar entry in the US
FDA begins listening exercise on biosimilar user fees
FDA considers similar user fees for original and biosimilar products
User fees are unlikely to have a negative impact on biosimilars producers entering the US
High interchangeability requirements limit uptake
The FDA is likely to make interchangeability
A lack of interchangeability could impact uptake
The FDA considers whether a biosimilar's INN differs from that of the reference product
The FDA also considers requirements for clinical data to be used in comparative studies
The debate of biologic exclusivity periods continues to rage
President Obama has yet to settle on biologic exclusivity requirements
New political and regulatory biosimilar initiatives
Members of Congress have created a forum to support biosimilar uptake
The FDA seeks discussion with the EMA
Biosimilars producers closely watch the FDA’s response to Teva’s Neutroval application
BIOSIMILAR REGULATORY DEVELOPMENTS IN EUROPE AND THE REST OF WORLD
EU to issue guidelines on beta interferons and monoclonal antibodies in 2011
The EMA is set to release new guidelines following public consultations
EU draft biosimilar monoclonal antibody guidance
The EU biosimilars pathway is obviously a huge opportunity for biosimilar players
Regulatory authorities in the UK give their backing to a number of biosimilars
NICE recommends biosimilar somatropin and SMC approves fourth biosimilar
Biosimilars manufacturers should look to further demonstrate cost-effectiveness of their products
Norway forbids filgrastim substitution
Norwegian courts move to delist filgrastim biosimilars
Biosimilars producers will face a filgrastim uptake scenario similar to that in other European markets
Brazilian government enters into partnerships with domestic producers to bring biosimilars to market
The Brazilian government is to commercialize a biosimilar version of Humira
BIBLIOGRAPHY
Publications and online articles
Datamonitor reports and products
APPENDIX
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