How Robust are your Country's Biosimilar Medicine Policies?


About Biologics and Biosimilars

Biologic medicines have improved the health of millions of patients worldwide. Some examples include vaccines and therapeutic proteins that help your body to fight illnesses such as cancer and arthritis. As the patents for these medicines begin to expire, many companies have begun to develop copies of these medicines, known as biosimilars, similar biotherapeutic proteins, or subsequent entry biologics.

Unlike generic medicines, which are simple and can easily be copied identically, biologics are large, complex molecules that are made in living cells, and only similar, but not identical copies are possible. The safety and efficacy of the biologic is completely dependent on the type of cells that are used to make the biologic, and manufacturing process, and clinical trials are often required to evaluate clinical performance.

Because of this, the approach established to evaluate generic medicines is not an appropriate standard for biologics, and regulatory agencies responsible for drug approvals, have begun to develop guidelines and standards to evaluate biosimilar medicines.

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About CBPE

The guidelines and standards for evaluating biosimilar medicines vary in different regions and countries around the world. The Center for Biologic Policy Evaluation, or CBPE, was established as an independent organization to impartially evaluate these regulatory policies, measured against global standards set forth by the World Health Organization.

Our mission is to serve as a resource for the world’s regulators, foster international collaboration and cooperation, and promote the drafting of biologic policy that is science-based and medically appropriate

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About This Analysis

We evaluated biosimilar guidelines from 12 countries and regions around the world, to determine whether the standard of evidence required for approval is sufficient to ensure public health.

Each country or region was evaluated on 28 aspects of biosimilars policy (listed here) and rated on a scale of 1-5 (in 0.5 level increments) as compared with the WHO guidelines as follows:

  • 1-2 minimally compliant with WHO regulations
  • 3-4 partially compliant with WHO regulations
  • 4 fully compliant with WHO regulations
  • 5 exceeds the standards set by WHO

The scores across these 28 categories was averaged to give an overall score out of 5. Hover over the map to see your country or region’s score, and click on your country or region to find out more. More detail on WHO’s biosimilar guidelines can be found here.