Biosimilars Market Regulatory Framework, Pipeline Analysis, 2015 Biologics and Biosimilars Industry and Japan Pharma Outlook 2015 Review in New Research Reports

DALLAS, July 15, 2015 /PRNewswire/ --

RnRMarketResearch.com adds new biosimilars market research reports titled BIOSIMILARS - Regulatory Framework and Pipeline Analysis, 2015 Deep Research Report on Global Biologics and Biosimilars Industry and Japan Pharma Outlook 2015: 2015 -Year to Watch out for Authorized Generics (AGs), Biosimilars and Overseas Strategic Initiatives to the pharmaceuticals collection of its library.

Complete report on biosimilars market regulatory framework and pipeline spread across 94 pages and providing outlook for Europe, USA, India, South Korea, Japan and China is now available at http://www.rnrmarketresearch.com/biosimilars-regulatory-framework-and-pipeline-analysis-market-report.html .

All countries are focusing on reducing the healthcare expenditure and biosimilars market 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.

The scope of this 2015 biosimilars market report on regulatory framework and pipeline analysis includes information on market dynamics including 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 and late-stage / phase ii / phase i pipeline biosimilars. Order a copy of BIOSIMILARS - Regulatory Framework and Pipeline Analysis 2015 market research report at http://www.rnrmarketresearch.com/contacts/purchase?rname=394387 .

The new biosimilars market report will enhance decision-making capability by allowing readers to 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. Examine the biosimilars pipeline and specifies the products that are highly targeted, it also includes analysis of highly focused indications, mechanism of actions, and therapy areas in the pipeline. Analyze the details of the clinical pipeline that includes late stage products, Phase II, and Phase I products. Detailed understanding of the pipeline will help in targeting the products for development, rate the current products and predict the competition.

The second study titled 2015 Deep Research Report on Global Biologics and Biosimilars Industry is spread across 170 pages, provides 2016-2021 forecasts, profiles 15 biologics companies & 9 biosimilar companies and the biosimilars market analysis of this research is supported with 175 tables and figures. Biologics companies like Pfizer, Roche, Amgen, AbbVie, Sanofi, Johnson & Johnson, Novo Nordisk, Novartis, Merck, Lilly, 3sbio, Changchun High and New Technology Industry (Group) Inc., CP Guojian Pharmacy, Biotech Pharma and Gelgen Biopharma are profiled in this research. Biosimilars market companies profiled in the report are SANDOZ (NOVARTIS), Teva Pharmaceutical Industries , Hospira  Pfizer , MYLAN INC., 3sbio, Changchun High and New Technology Industry (Group) Inc.  , CP Guojian Pharmacy, Biotech Pharma  and Gelgen Biopharma. Comprehensive table of contents, list of tables and figures in this report is available at http://www.rnrmarketresearch.com/2015-market-research-report-on-global-biologics-and-biosimilars-industry-market-report.html .

The third research titled Japan Pharma Outlook 2015: 2015 -Year to Watch out for Authorized Generics (AGs), Biosimilars and Overseas Strategic Initiatives says most of the companies are revalidating their domestic (and thus overseas) strategies to adopt with new regulations. For the innovators - testing Authorized Generics (AGs) phenomenon for protecting their long-listed sales against generic could be one of new choice in Japan. The format and regulations for AG's are still not clear in Japan, however with the largest Japanese product Blopress AG's launched recently and generic companies in queue to compete with their generic versions will make the things lucid for the fate of AG's in Japan.

For most of the generic companies focusing on reducing manufacturing costs, and for many of them to venture in biosimilars space as a new growth avenue would be focus. The trends suggest that Japanese companies may need to set up or alliance with companies overseas for manufacturing. In this note of Outlook-15, we look deeper into these trends to anticipate likely near term changes of Japanese pharma industry.

In innovation space, after Oncology, regenerative medicine and Orphan disease are the areas where Japanese innovator companies are focusing its R & D efforts. While from late stage pipeline/new launch, Edoxaban, Lenvatinib, Entyvio, Brintellix, and Ixazomib are the few important NCEs, uptake of which will decide Japanese Innovator growth in Global market. In this report- We analyzed pipeline, strategies and key growth drivers of 13 major Japanese biopharma companies (Pure play innovators/ Innovators+ Generics/Pure play generics) and detailed our view on these growth drivers along with their interest for inlicensing external innovation from the globe for increasing R&D productivity.

Companies mentioned in this Japan pharma market outlook 2015 report include Astellas, Chugai,Daiichi Sankyo, Dainippon Sumitomo Pharma, Eisai, Kyowa Hakko Kirin, Meiji Seika, Mitsubishi Tanabe, Shionogi, Symbio, Takeda, Towa, Sawai and Nippon Chemiphar. Read more at http://www.rnrmarketresearch.com/japan-pharma-outlook-2015-2015-year-to-watch-out-for-authorized-generics-ags-biosimilars-and-overseas-strategic-initiatives-market-report.html .

Explore more reports on the biosimilars market as well as overall pharmaceuticals industry at http://www.rnrmarketresearch.com/reports/life-sciences/pharmaceuticals .

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