Biosimilars and other copies of biological products

Biosimilares/Investigación | Posted 20/04/2023 post-comment0 Post your comment

The Commentary by Kurki P [1] is a response to the article of Klein et al. [2] that deals with copies of original biotherapeutics, biosimilars and non-biosimilars, marketed in 15 low- and middle-income countries (LMIC).

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Data of these products are difficult to trace. Klein et al. present a cross-sectional overview of 305 products representing 18 active substances based on publicly available data from several sources. Sixty-eight products were also licensed in the major biosimilar markets (USA, EU, Canada, Australia and Japan). These products are regarded as genuine biosimilars since they will conform with the guidelines of the World Health Organization (WHO). 

The rest of the 237 products did not or may not fulfil the WHO requirements for biosimilars. Most (80%) products were manufactured and licensed in only one country. Most manufacturers are from India, China, Russia, Iran and Argentina. Klein et al. suggest that these products may represent a problem from a public health point of view since the data that led to their licenses are either unknown or incomplete regarding appropriate comparability studies. The authors propose that WHO will conduct a wider study of the licensing grounds of the copy biologicals in LMIC countries.

According to the commentary, transparency is useful for monitoring the ongoing slow transit from non-biosimilars to genuine biosimilars that are developed according to the WHO guidelines. WHO has asked for information of the non-biosimilar products, but some national regulatory agencies seem reluctant to disclose all data [3].  Such information may lead to problems if the data are used to challenge licenses granted in LMIC countries. This might cause true public health problems if affordable biosimilars are not available for replacement. 

Thus, the main effort should be put on acceleration of adoption of the WHO biosimilar guidelines by national regulatory authorities and on strengthening the regulatory cohesion between LMICs. In addition, WHO should inform current and potential manufactures of copy biologicals about the recently revised WHO guidelines that allow reduced non-clinical and clinical data packages [4]. The increase in the number of manufacturers developing biosimilars will trigger price competition that may finally bring affordable biosimilars to the markets of LMICs.

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

Abstracted by Professor Pekka Kurki, University of Helsinki, Helsinki, Finland.

Editor’s comment
Readers interested to learn more about factors for successful uptake of biosimilars in Europe and the US are invited to visit to view the following manuscript published in GaBI Journal:

Key factors for successful uptake of biosimilars: Europe and the US

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1. Kurki P. Copies of biological medicines: similar but not the same? BioDrugs. 2023;37:123-6.
2. Klein K, Gencoglu M, Heisterberg J, et al. The global landscape of manufacturers of follow-on biologics: an overview of five major biosimilar markets and 15 countries. BioDrugs. 2023;37:235-45.
3. Kang H-N, Thorpe R, Knezevic I, et al. Regulatory challenges with biosimilars: an update from 20 countries. Ann N Y Acad Sci. 2021;1491(1):42-59.
4. Kang H-N, Wadhwa M, Knezevic I, et al. WHO guidelines on biosimilars: toward improved access to safe and effective products. Ann N Y Acad Sci. 2023;1521(1):96-103.

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