Infographic: Global Biosimilars Pathways and Clinical Development Activity
Where Are the Biosimilars Hotspots?

“This infographic is based on insights from the Biosimilars Advisory Service. Key findings from the report entitled Global Biosimilars Markets: Pipelines, Regulations, and Major Players also include:”

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 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.
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