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The Global Biosimilars Pipeline Has Expanded by Over 40 Percent in the Last 12 Months

Companies mentioned in this article: Decision Resources Group

BURLINGTON, Mass., April 22, 2014 /PRNewswire/ -- Decision Resources Group finds that the number of publically disclosed biosimilar development projects has increased by more than 40 percent in the last 12 months. The majority of these development projects are yet to enter clinical development, but the 20 percent annual increase in the number of biosimilars in clinical trials indicates substantial advancement in the late-stage pipeline as well.

Other key findings from the Biosimilars Advisory Service report entitled Global Biosimilars Markets: Pipelines, Regulations, and Major Players:

    --  Greatest increase in biosimilar candidates: South American companies
        have achieved the biggest increase in the number of biosimilars in
        development, driven by the large number of Brazilian Productive
        Development Partnerships that have been struck between public
        organizations and industry to bring biosimilar manufacturing into the
    --  Most prolific biosimilar developers: Indian companies have disclosed
        more biosimilar development projects than regional companies located in
        any other country, but it remains unclear whether Indian regulators have
        begun enforcing the 2012 biosimilars guidelines.
    --  Most popular biosimilar targets: Among biosimilar developers, monoclonal
        antibodies--such as rituximab and trastuzumab--are firmly entrenched as
        the most popular targets, largely due to the high sales captured by the
        reference brands and the imminent patent expiries in major markets.
    --  Regulatory challenges persist: Regulatory guidelines for biosimilars
        have been adopted in over 60 countries to date, but global harmonization
        of requirements for approval remains a future ideal, rather than a

Comments from Decision Resources Group Senior Director of Biosimilars Research Kate Keeping:

    --  "The rapid expansion of the biosimilar development pipeline shows that
        there is no sign of the commercial threat from biosimilars going away
        for innovator companies. However, the remarkable speed of pipeline
        growth will be better news for over-stretched healthcare budgets that
        urgently need more affordable biologic medicines."
    --  "Biosimilar manufacturers face many challenges, such as upfront
        manufacturing costs, demonstrating biosimilarity, designing clinical
        trials to meet ever-changing regulations, assuaging physician concerns
        about comparability to the original brand, and product differentiation.
        We are still a long way from global harmonization, so it is critical to
        understand the regional differences within the competitive and
        regulatory landscape."

Additional Resources: Click here to view an infographic entitled Global Biosimilars Pathways and Clinical Development Activity.

About Decision Resources Group

Decision Resources Group offers best-in-class, high-value information and insights on critical issues within the healthcare industry. Clients rely on this analysis and data to make informed decisions. Find out more at

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For more information, contact:

Decision Resources Group
Christopher Comfort


SOURCE Decision Resources Group