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Global Biosimilars: A return to optimism?

o appear, and in May 2011 FDA published details for User Fees – a scheme that will not come into effect
(assuming it is passed by Congress) until 2013. Given that an untried regulatory system will not operate at the fastest speed then prospects of a US market for advanced biosimilars seem remote before 2015. In contrast, European regulators are revising their widely-adopted regulations in the light of experience, with a view to issuing revisions and guidance in 2012.

Developing markets may offer a profitable alternative
Developing markets with rising disposable incomes may present the medium-term prospect for biosimilars, since they combine a large target population with reduced operating costs. Many countries are following the EU model of regulation. Markets such as India and China have plenty of home-grown production capacity. Some companies
have sought to turn this capacity to their advantage, and have signed deals with Chinese/Indian producers for the development of products to be sold around the world.

This report provides a comprehensive insight to the market environment,
current and future products and the companies involved.
A complete examination of the regulatory situation in the US, Europe and emerging markets
Detailed assessment of current biosimilar products and developers with market share by product
- Human Insulin
- Interferon (alfa & beta)
Identification and analysis of likely second wave of advanced biologics to come to the market
- Adalimumab
- Etanercept
- Infliximab
- Rituximab
- Trastuzumab

A review of operational issues that will affect the adoption of biosimilars including pricing/reimbursement, clinician attitudes and patient acceptance
The position, activity, products, pipeline and plans of 50 leading players in the field

The Challenge for Industry
The dev

SOURCE Reportlinker
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