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Aarkstore.com announce a new report "Biosimilars: Current Situation & Future Prospects, Worldwide" through its vast collection of market research report.
Aarkstore.com announces, a new market research report is available in its vast collection Biosimilars: Current Situation & Future Prospects, Worldwide http://www.aarkstore.com/reports/Biosimilars-Current-Situation-Future-Prospects-Worldwide- 192195.html http://www.aarkstore.com/feeds/JustPharmaReports.xml Summary: 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? 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: 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 Table of Contents : 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 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 For More details Plz do contact : Aarkstore Enterprise Phone:08149852585 Email: email@example.com URL:www.aarkstore.com Our Website :www.aarkstore.com Facebook: http://www.facebook.com/aarkstore Linkedin: http://in.linkedin.com/in/aarkstore
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