Biosimilars Market - Worldwide Biosimilars Industry Share, Size, Trends, Global, Current Situation & Future Prospects Research Report Available at MarketResearchReports.Biz
Albany, New York (PRWEB) July 02, 2013 -- 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?
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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 provide the answers, including:
On the basis of several years market experience in Europe and Japan, where and with which biosimilars has the most and least success been achieved, and why.
Complexities of biological parents.
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
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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
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Table Of Content
1. Introduction
Biosimilarity
Rationale for biosimilars
Regulatory guidelines
Types of biosimilars
Lack of standardization
Market situation
2. Safety Concerns
Issues with biosimilars
Issues with originator products
Immunogenicity
Exchangeability
Traceability
Nomenclature
Scare stories
3. Regulatory Developments in Europe
Biosimilar pathway
Regulatory guidelines
Risk management plans
Regulatory approvals
Other products
Withdrawals
Intellectual property protection
Prescribing and substitution
Hospital market and tendering
4. Market Access Situation in Europe
Launches
Sales
Market opportunity
Product-specific features
Country-specific features
Savings
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