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.
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 country.
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 reality.
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.
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