London, UK (PRWEB) July 13, 2015
Nowadays, biosimilars are getting increased attention from pole to pole. The cost of innovative biologics is extremely high, and even minimal reduction of prices will likely substantially reduce the healthcare expenditures. Different nations focus on cutting down the healthcare spending, and biosimilar drugs help in the achievement of this goal. Biologic products have complex structures and complex production processes; thus, some kind of variation exists between the reference product and its biosimilar. It is important to evaluate variations in biosimilars by comparing them with a reference product to provide quality, non-clinical and clinical characteristics, which help to establish regulatory requirements for biosimilars. Regulatory requirement for approving biosimilars differs across various regulatory authorities. Still, all the nations have derived the dominant theme from the World Health Organization (WHO) and the European Medicines Agency (EMA) guidelines for framing their regulatory structure. There is a need to harmonise the nomenclature of biosimilars, extrapolation of indications, and interchangeability of biosimilars with reference products across the governing bodies. Currently, the biosimilars market growth is gaining traction. This market is well established and will likely see an inflow of novel biosimilars in the short run.
Topical market research study “BIOSIMILARS - Regulatory Framework and Pipeline Analysis” developed by CBR Pharma Insights is now available at MarketPublishers.com.
Title: BIOSIMILARS - Regulatory Framework and Pipeline Analysis
Published: June, 2014
Price: US$ 2,995.00
The research report provides in-depth analysis of the biosimilars market dynamics, covering trends, barriers and drivers. It provides the WHO guidance for biosimilars, gives a regulatory overview, provides a slew of biosimilar guidelines, describes the regulatory framework for biosimilars, and also offers a detailed market outlook for Europe, the USA, South Korea, India, China and Japan. An exhaustive analysis of the leading players is available. The study also contains a granular pipeline overview and analysis based on development stage, molecule, therapy area, and by indication. Biosimilars are reviewed in late-stage, Phase II and Phase I trials.
Reasons to Buy:
- Get an understanding of the regulatory scene and regulatory framework which facilitates efficient product development strategy.
- Compare various regulatory frameworks across geographies and design an effective strategy to enter the developed markets.
- Gain insight into the post approval market landscape.
- Get insight into the biosimilars pipeline and discover the products that are highly targeted, as well as learn about highly focused indications, MoAs, and therapy areas in the pipeline.
- Get a refined understanding of the clinical pipeline to effectively target the products for development, rate the existing products and also predict the future competition.
More reports by the publisher can be found at CBR Pharma Insights page.