Biosimilars, also known as “follow-on biologics,” “similar biologics,” “biogenerics,” etc. are the generic versions of the biologic drugs. They are important biotherapeutic drugs that are used for the treatment of several serious and debilitating diseases. Most of the innovator biologics are billion-dollar drugs and have a sizeable share of the biopharmaceuticals market. The high cost associated with the biologics has created a situation of limited access for millions of patients around the globe, in particular, the emerging countries. The patent expirations of the blockbuster drugs have led to a growing interest in the development of biosimilars. Biosimilars have the potential to allow wide and affordable access of the drugs due to their lower cost.
It has been noted by industry analysts that, compared to an originator biologic, a biosimilar takes 60% less time to reach the market, with development costs only 15% to 20% of those of the biologics. Their prices being 20% to 30% cheaper than the original drugs, the biosimilars offer increased opportunity for patients, healthcare providers, and manufacturing companies alike.
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The cost-effectiveness of biosimilars, soon-to-market approval option, and the billions of dollars’ worth market of term-end innovator biologics is luring many small and big pharmaceutical companies to capitalize in this market. The biosimilar industry comprises of pharmaceutical companies that range from clinical-stage companies to small-pharma companies with limited capabilities, as well as bigger pharmaceutical giants with established markets. Though the domestic markets are more flourished in the current situation, collaborations and partnerships proving as popular strategies to gain market share globally.
Europe has set an example for other countries by establishing a well-worked framework for the approval of biosimilars. The U.S., with the enactment if the Affordable Care Act in 2010, also entered this market in 2015. Emerging markets, including countries in Asia, Latin America, Russia, etc., have several biosimilar products in the market since the early 2000s. The products in these countries were, however, considered inferior in quality as these countries did not have any regulatory guidelines for biosimilar approvals. Lack of any patent regulation also favored these countries and allowed the market of biosimilars to flourish in the emerging markets. Governments of many countries have now adopted the biosimilar guidelines, encouraging the growth of global biosimilars market. Although, the acceptance of biosimilar drugs has been slow in the U.S., the recent approvals by the Food and Drug Administration (FDA) amounting to eight approvals in 2016 and 2017 in contrast to a single approval in 2015, show that the trend towards biosimilars in the developed world is gaining traction.
The global biosimilars market is driven primarily by the blockbuster products and the related research pipeline. Currently, there is only a limited number of biosimilars in the market, restricted to the categories of growth hormones, growth factors, monoclonal antibodies, fusion proteins, interferons, and low-molecular-weight heparins (LMWHs). During the examined period of this report, many more biosimilars, particularly in the categories of monoclonal antibodies indicated for the treatment of cancer, various autoimmune diseases, infectious diseases, and others are expected to be launched due to their impending patent expirations in the U.S. and Europe. There are at least 43 potential biosimilars candidates that are in late-stage clinical trials. The market of biosimilars is also encouraged by the successful joint ventures, collaborations and partnerships, and various licensing arrangements that are helping to boost the technical expertise, intellectual know-how, and market access for the partnering companies. An increase in the aging population, rising incidences of various diseases, and increasing pressure to cut healthcare expenditures are the growth drivers for the biosimilars market.Report Scope:
Biosimilars are replicas of the innovator biopharmaceuticals. They offer the advantage of being less expensive as compared to their expensive counterparts. The structural and manufacturing complexities associated with their development have led to extensive approval guidelines and regulations by the federal agencies. This report examines the biosimilar drugs in detail and provides an updated overview including its applications in various arenas of disease sectors. The importance of analytical technologies in the biosimilar manufacturing led BCC Research to focus specifically on the current and emerging trends in biosimilar manufacturing and analytical testing.
Also included in the report are relevant patent analysis and comprehensive profiles of companies that lead the biosimilar drugs industry. The company profiles highlight the bosimilar pipelines of relevant companies. Some of the major players of the market include Pfizer Inc., Sandoz International GmbH, Biocon Ltd., Dr Reddy’s Laboratories Ltd., Amgen Inc., Teva Pharmaceuticals Inc., Celltrion Inc., Samsung Bioepis, and others.
The report has also dealt with biobetters, their approval mechanisms and importance in the industry. (Biobetters are described as new molecular entities that are related to existing biologics by target or action, but they are deliberately altered to improve disposition, safety, efficacy, or manufacturing attributes.)
Excluded from this report are the generics of small-molecule drugs, and the biologics per se. The different requirements for approval and bioequivalence between generics and biosimilars puts them in an entirely different regime. The diagnostic methods for monitoring disease progression are also outside the scope of this report.
– An overview of the global market for biosimilars
– Analyses of global market trends, with data from 2016 and 2017, and projections of compound annual growth rates (CAGRs) through 2022
– A look at biosimilar product classes in various regions worldwide, as well as the worldwide pipeline for biosimilars
– Detailed analysis of the emerging framework in regulated markets, as well as comparisons of biosimilar guidelines in Europe, the U.S., Japan, Canada, as well the guidelines developed by the – World Health Organization
– Technology trends and patent analyses
– Comprehensive company profiles of key players in the market, including Allergan Plc., Bioton S.A., Cinnagen, Emcure Pharmaceuticals Ltd., LG Life Sciences, Neuclone and Pfizer Inc.3S BIO INC.
ANHUI ANKE BIOTECHNOLOGY (GROUP) CO. LTD.
BHARAT SERUMS AND VACCINES LTD.
BIOTON S. A.
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