Biosimilars and the role of regulatory authorities Posted 22/06/2018

According to authors Hye-Na Kang and Ivana Knezevic, from the World Health Organization (WHO), market access to biosimilars can be restricted by several factors [1]: 
(i)   manufacturing processes may be expensive and complex
(ii)  patents on the manufacturing processes of the original product may not have expired
(iii) biosimilar manufacturers may have limited access to data on the original product
(iv)  appropriate regulatory frameworks may not be in place
(v)   government policies on switching to biosimilars, pricing and reimbursement may be lacking.

Experience with small-molecule generics has shown that gaining the trust of all stakeholders, including policymakers, regulators, physicians and other healthcare providers, is essential for increasing the uptake of biosimilars. the authors therefore recommend that governments should provide a robust regulatory framework; ensure intellectual property rights are respected; guarantee fair pricing; devise a policy on reimbursements and incentives; and ensure healthcare professionals and patients are fully informed.

One of the main barriers to the uptake of biosimilars is the perception that, they may not have been studied thoroughly enough and that, therefore, they may not be safe. This perception, according to Kang and Knezevic, comes from a lack of knowledge about the scientific principles underlying the development and licensing of biosimilars and to the inappropriate labelling of non-originator and copy-version products as biosimilars.

The authors therefore recommend that regulatory authorities develop a specific, appropriate, regulatory framework for approving biosimilars that is distinct from the regulatory procedures previously applied to copy-version products, where regulatory evaluation was not well-defined. Communication and education of patients is also highlighted as important. As part of this communication, publication of public assessment reports on biosimilars is recommended as a way to increase transparency and increase public trust in biosimilars.

The Biosimilar Working Group of the International Pharmaceutical Regulators Forum published a template for biosimilar assessment reports that could be used by regulators worldwide; it is entitled Public Assessment Summary Information for Biosimilars (PASIB) [2].

Other recommendations for improving access to biosimilars include:

  • increasing the efficiency of review processes and of regulatory evaluation, e.g. by increasing capacity and reducing the time needed
  • aligning national regulatory requirements with WHO’s guiding principles to avoid the need for bridging studies and to reduce development costs
  • carrying out joint, collaborative assessments with neighbouring countries, where appropriate, to avoid re-evaluating products that have already undergone rigorous evaluation in other countries.

Finally, in 2017 WHO launched a pilot project to prequalify two biosimilar monoclonal antibody products: rituximab and trastuzumab. The purpose of the pilot study was to explore the possibility of assisting countries with limited expertise and resources to evaluate such products, thereby increasing access to biosimilars [3].

Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest.

Related articles
Life cycle and regulatory evaluation of biosimilars

Regulating biosimilars throughout their life cycle

1.  Kang H-N, Knezevic I. Regulatory evaluation of biosimilars throughout their product life-cycle. Bull World Health Organ. 2018;96(4):281-5.
2.  GaBI Online - Generics and Biosimilars Initiative. IPRF template for summary information for biosimilar reviews []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 22]. Available from:
3.  GaBI Online - Generics and Biosimilars Initiative. WHO launches consultation on prequalification of biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 22]. Available from:

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