• Japanese
  • Korean
  • Chinese
Cover Image

Biosimilars: Global Regulatory Update



After consultation with industry, the FDA published draft biosimilars guidelines in February 2012. Although details are lacking in a number of areas such as interchangeability, the guidance sets out the agency's broad views and gives developers greater certainty for the initiation of development programs.

Features and benefits

  • Insight into the key biosimilar regulatory developments globally
  • Assessment of the key strategies incorporated by players as a response to these changes in biosimilar regulation


The FDA published draft biosimilars guidelines in February 2012.

In the EU, the EMA has published guidance for the development of interferon beta biosimilars.

In order to meet physician and patient demands for more complex drugs and reduce the financial burden on payers, the Iranian government is keen to promote the Iranian biosimilars industry.

Your key questions answered

  • Evaluate the evolving regulatory environment around the world and how this impacts biosimilar market access and uptake.
  • Gain insight into the strategies employed by payers and pharmaceutical companies as a response to these changes in the regulatory environment.

Table of Contents


  • PharmaVitae Explorer database


  • Introduction
  • Key findings
    • Other US biosimilars regulatory issues
    • EU biosimilar regulatory developments
    • Rest of world biosimilar regulatory developments
    • Country-specific biosimilar definitions
  • Biosimilars approval pathways


  • FDA biosimilar development guidelines outline the agency's current thinking
    • (Untitled sub-section)
    • Reference product considerations
    • Biosimilar design and manufacturing
    • Preclinical studies
    • Clinical studies
    • Indication extrapolation
    • Interchangeability requirements
    • Post-marketing requirements
  • PDUFA V to be approved by September 2012
    • The FDA aims to review biosimilar applications within 10 months
  • EU issues new guidelines
    • EU issues draft interferon beta guidelines
    • German reference price cuts to affect biosimilar epoetins
    • Belgium to set biosimilar target
  • Emerging markets


  • References
    • Datamonitor reports
  • Exchange rates


  • Table: Biosimilars approval pathways
  • Table: Comparison of biosimilar guidelines across major markets, 2012
  • Table: Comparison of biosimilar guidelines across major markets, 2012
  • Table: EMA H1 2012 biosimilars guidance timetable
  • Table: Pipeline and marketed biosimilar/copy-biologic interferon beta drugs
  • Table: Germany - biosimilar epoetin products marketed in Germany, 2012
  • Table: Exchange rates, 2011


  • Figure: The PharmaVitae Explorer
Show More