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Biosimilars: Current Situation & Future Prospects, Worldwide



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
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


Rationale for biosimilars

Regulatory guidelines

Types of biosimilars

Lack of standardisation

Market situation

2. Safety Concerns

Issues with biosimilars

Issues with originator products




Scare stories

3. Regulatory Developments in Europe

Biosimilar pathway

Regulatory guidelines

Risk management plans

Regulatory approvals

Other products


Intellectual property protection

Prescribing and substitution

Hospital market and tendering

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