The Significant Number Of Countries With Biosimilar Regulatory Pathways And A Global Desire For More Affordable Healthcare Support The Introduction Of A Global Regulatory Process For Biosimilars
Analysis of the Global Pipeline of Biosimilars Shows That Indian and South Korean Companies Have the Broadest Portfolios
EXTON, Pa., April 15, 2013 /PRNewswire/ — BioTrends Research Group, one of the world’s leading research and advisory firms for specialized biopharmaceutical issues, finds that the majority of surveyed U.S. and European physicians and payers are in favor of the introduction of a global regulatory pathway for biosimilars, while the European Medicines Agency’s (EMA) recent decision to accept reference products sourced from outside Europe demonstrates a growing interest in simplifying approval of biosimilars. According to Biosimilars Advisory Service: Global Pipelines, Regulatory Pathways, and Key Stakeholder Perspectives of Biosimilars, for a global pathway to become a reality, the biosimilar market must overcome further hurdles involving the source of reference product, differences in scope and trial requirements across regulatory agencies.
“A global biosimilar pathway would eradicate the need to repeat clinical trials in multiple countries, which in turn would reduce development costs and enable companies to lower prices, as well as improve speed to market,” said Kate Keeping, Director of the Biosimilars Advisory Service at Decision Resources Group.
The 2013 Biosimilars Advisory Service report also includes in-depth analysis of the global pipeline of biosimilars and finds that there are high levels of biosimilar development activity particularly among Indian and South Korean companies. Additionally, regulators in more than 20 markets, recognizing the safety and efficacy benefits of performing a robust clinical comparability exercise, have adopted development guidelines comparable to those established by the EMA and World Health Organization (WHO).
The Biosimilars Advisory Service provides insight and analysis that is vital to successful business planning in the rapidly evolving biosimilars space. The service includes quarterly webinars detailing major developments, analyst insight addressing key market changes and opportunities, therapeutic area-specific primary research and forecasting modules.
About BioTrends Research Group
BioTrends Research Group provides syndicated and custom primary market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please visit www.Bio-Trends.com. BioTrends is a Decision Resources Group company.
About Decision Resources Group
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SOURCE BioTrends Research Group