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(Health-NewsWire.Net, July 07, 2015 ) All the countries are focusing on reducing the healthcare expenditure and biosimilars compliments to this goal. Biologic products are complex in structure and follow a complex manufacturing process thus, some variation exists between the reference product and its biosimilar. It is very important to assess the variations in biosimilars by comparing with reference product to ensure quality, non-clinical, and clinical properties, which has given rise to the regulatory requirements for biosimilars. Regulatory requirement for approving biosimilars varies across different regulatory bodies. However, all the countries have derived the basic theme from EMA and WHO guidelines for framing their regulatory structure. There is a need to harmonize the nomenclature of biosimilars, extrapolation of indications, and interchangeability of biosimilars with reference products across the regulatory bodies. Biosimilars market is developing and it could be well established with the pipeline that is poised to deliver a wave of biosimilars in the market in the near future
Scope:
• Introduction
• Market dynamics: Trends, Drivers, and Barriers
• WHO guidance for biosimilars
• Regulatory overview, biosimilar guidelines, regulatory framework for biosimilars, and market outlook for: Europe, USA, India, South Korea, Japan and China.
• Key players
• Pipeline Analysis
• Overview
• By Stage of Development / Molecule / Therapy Area / Indication
Inquire for discount on this report at http://www.rnrmarketresearch.com/contacts/discount?rname=394387 . (This is a premium report price at US$2995 for a single user PDF license)
Reasons to Buy:
• Understand the regulatory requirement and regulatory framework that facilitates effective product development strategy as biosimilars industry is currently highly focused, growing, and outpacing the growth rate of small molecule pharmaceutical market
• Targeting geographies would be easy by comparing different regulatory frameworks; this would also provide a base for designing a strategy to enter the developed markets. Biosimilars are of interest in developed countries to reduce the healthcare expenditure
• With the recent approvals of biosimilars by USFDA, the biosimilars market is going to grow and this report examines the post approval market landscape
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Complete report is available at http://www.rnrmarketresearch.com/global-opioid-induced-constipation-market-2015-2019-market-report.html .
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