Skip to main content


Remaining Challenges, Potential Solutions for the Regulatory Evaluation of Biosimilars

December 16, 2020

A recent article published in Annals of the New York Academy of Sciences addresses challenges regarding the regulatory evaluation of biosimilars, as well as offers potential solutions to these challenges (2020. doi:10.1111/nyas.14522).

“The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices,” explained the study authors.

A recent WHO survey conducted in 2019-2020 revealed 4 remaining challenges despite the WHO guideline effort. They include:

  1. Unavailable/insufficient reference products in the country
  2. Lack of resources
  3. Problems with the quality of some biosimilars (and even more with noninnovator products)
  4. Difficulties with the practice of interchangeability and naming of biosimilars

Authors present solutions to the remaining challenges, which includes:

  1. Exchange of information on products with other regulatory authorities and accepting foreign licensed and sourced reference products
  2. Use of a “reliance” concept and/or joint review for the assessment and approval of biosimilars
  3. Review and reassessment of the products already approved before the establishment of a regulatory framework for biosimilar approval
  4. Setting appropriate regulatory oversight for good pharmacovigilance

“Information sharing and well‐documented history provided by healthcare professionals of their experience on the interchangeability of biosimilars and their use in replacement of their reference products might contribute to an increasing rate of acceptance of biosimilars for use by other professionals and patients,” concluded the study authors.—Lisa Kuhns

Back to Top