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Biosimilars : Current Situation & Future Prospects, Worldwide

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					Biosimilars : Current Situation & Future Prospects, Worldwide

Bharatbook from its exhaustive collection has come out with a report " Biosimilars :
Current Situation & Future Prospects, Worldwide " which gives an overview, Demand,
Supply Trends and industry analysis reports.

 The engine of the biosimilar sector is the same as with small molecule drugs, patent
expiry. On this basis, prospects for biosimilars look good, with the vast majority of
leading originator brands in the global biologics market expected to lose some degree of
protection by 2019. All major countries now make provision for an abbreviated
biosimilar development and regulatory pathway. Funds are flowing into the sector and
many new partnership agreements signed. Everything in the biosimilar garden might look
rosy, but what is the reality? http://www.bharatbook.com/market-research-
reports/healthcare-market-research-report/biosimilars-current-situation-future-prospects-
worldwide.html

 Biosimilar sales of $16+ billion were forecast in the EU and US alone for 2011.This
estimate turned out to be 50-times too high. Does publication of the long-awaited
guidance on the US Biologics Price Competition and Innovation Act mean a new dawn
for biosimilars, or another false one? Written with the understandable detail and
objectivity you need, Biosimilars: Current Situation & Future Prospects, Worldwide
provides the answers, including: Market Research Companies

 - On the basis of several years market experience in Europe and Japan, where and with
which biosimilars has most and least success been achieved, and why.
 - Complexities of biological patents.
 - The big controversies with biosimilars explained: Sourcing of reference products,
similarity, naming, interchangeability, immunogenicity, traceability, indication
extrapolation.
 - Where payers incentivise usage of biosimilars.
 - The importance of devices to administer biosimilars.
 - Which companies are most active in biosimilar development, what are their targets and
how far have they reached.
 - Where biosimilar prospects are brightest through 2016

 * Comprehensive: From patents/data exclusivity via development, manufacturing issues
to regulatory requirements, pricing and reimbursement demands, funding provisions and
beyond to the realities of the market – it’s all here
 * Global: The situation in 27 developed and developing countries - across Europe, the
Americas, Asia-Pacific and the Indian subcontinent
 * Up-to-date: Includes 2011 sales data and February 2012 proposed FDA guidance
 * Fact-filled: Over 60 tables

Executive Summary
1. Introduction
Biosimilarity
Rationale for biosimilars
Regulatory guidelines
Types of biosimilars
Lack of standardisation
Market situation

2. Safety Concerns
Issues with biosimilars
Issues with originator products
Immunogenicity
Exchangeability
Traceability
Nomenclature
Scare stories

For more information kindly visit :
Biosimilars : Current Situation & Future Prospects, Worldwide

Or

Bharat Book Bureau
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Fax: + 91 22 27812290
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Drugs, Medicines, Healthcare, Biosimilars, Market Research Reports

				
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posted:3/26/2012
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Description: Bharatbook from its exhaustive collection has come out with a report " Biosimilars : Current Situation & Future Prospects, Worldwide " which gives an overview,�Demand, Supply Trends and industry analysis reports.