Pharmacy-mediated substitution of biosimilars: a global perspective

Category: Original Research
Author(s): , ,
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Keywords: biosimilars, global, interchangeability, pharmacy, regulation, substitution

Introduction / Study Objectives: Between March – May 2017, Pfizer conducted an internal global survey in 82 countries examining pharmacy-mediated substitution relating to biosimilars to better understand the global landscape.
Methods: Pfizer regulatory and corporate affairs colleagues completed a questionnaire:

  • Are pharmacists in your country able to substitute a biologic with a biosimilar without the physician being involved? Yes, no or situation unclear.
  • If pharmacists are able to substitute biologics with biosimilars, are there any restrictions or conditions?
  • Can you provide any additional information on biosimilar substitution policies in your country?

Results: The key finding was in 72% of countries surveyed, substitution of biosimilars at the pharmacy level does not occur, either because it is not permitted or for other reasons. In countries where pharmacy-mediated substitution is permitted, there are often restrictions in place.
Discussion: In Europe, North America and Asia-Pacific, many countries have developed specific policies on pharmacy-mediated substitution relating to biosimilars. Whereas, in Latin America, Africa and the Middle East, there are largely no policies on this matter; the focus appears to remain on the development of general biosimilar regulations and guidances.
Conclusion: Due to the complexity of biologics, it is our opinion that pharmacy-mediated substitution is not appropriate unless stringent regulatory and legal criteria additional to appropriate biosimilarity requirements can be met, as outlined in the IFPMA’s position paper on pharmacy-mediated substitution. In countries where no additional scientific standard exists for biosimilar substitution, the physician should remain involved in decisions regarding patient treatment.

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