BIOSIMILARS - Regulatory Framework and Pipeline Analysis
Summary
Biosimilars are copied versions of biologics that offer a 20-50% reduction in cost compared with innovative biologic products. BIOSIMILARS are getting the world wide attention as the cost of the innovative biologics are enormously high and even minimal reduction in price will reduce the healthcare spending substantially. 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
- What are the drug delivery technologies used in the market and how have they evolved in recent years? - What will be the market value, by revenue, of the market over the coming years? Drivers and restraints in the drug delivery industry: - What are the most important factors promoting growth in the market at a global level? - What are the most important factors restraining growth in the market? - What is the impact of novel delivery systems on the management of a product’s lifecycle? - Will emerging markets contribute significantly to the growth of the global market? - How will regulatory- and reimbursement-related challenges hinder the market? Technologies based on drug vehicle/carriers:
Key Reasons to Purchase
- Gain insightful analyses and understanding of market dynamics. The report comprehensively describes and assesses the most important factors driving and restraining the drug delivery technology market. - Evaluate a granular assessment of the pipelines for the various drug delivery technology segments and the prospects and revenue forecasts for the upcoming delivery technologies until 2020. - Evaluate the strategies and business models used by companies to achieve their full commercial potential. - Gain insight on upcoming trends and factors influencing the global market for drug delivery technology.
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