Biosimilars and interchangeability in oncology

Biosimilars/Research | Posted 03/09/2021 post-comment0 Post your comment

Researchers from Brazil investigated, from a pharmaceutical perspective, a major problem of the present time, which is the interchangeability of biosimilars [1].

Switching mAb Pfizer V18K30

Biosimilars used in the treatment of cancer are presented as an opportunity to reduce costs in cancer treatment and increase competition in the market for biologicals, allowing patients access to the treatment they need. In addition, they make it possible to change the therapeutic scenario of cancer patients.

To this end, the authors therefore carried out a literature review using the descriptors ‘biosimilar’, ‘oncology therapy’, ‘interchangeable drugs’ and ‘biological products’, in the ScienceDirect, MEDLINE and CAPLUS databases. From this search, 51 articles were selected, which addressed the importance of establishing standards that demonstrate the efficacy and safety of biosimilars with reference products, as well as the growing interest of the pharmaceutical industry in the development of biosimilars and the impact on costs and changes in the perspective of the treatment of cancer patients.

As patents expire, there is the possibility of developing biosimilars. However, these products are unlike generics, as they are large and complex molecules. It is therefore impossible to obtain identical copies of their reference products, which generates conflicts and concerns on the part of the pharmaceutical class regarding the safety of the interchangeability of these products.

The authors found that since biosimilars were approved for commercialization, there is still no global consensus on the best way to compare biosimilars with their reference products. They also found that some drug regulatory agencies such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Brazil’s ANVISA (Agência Nacional de Vigilância Sanitária), allow the interchangeability of biosimilars as long as they present biological activity studies that demonstrate that their effectiveness is similar to their reference product.

The authors concluded that it is important that the pharmaceutical professional evaluate their commercial use through pharmacovigilance, assessing the risk-benefit of the interchangeability of these products.

Conflict of interest
The authors of the research paper [1] did not provide any conflict of interest statement.

Abstracted by Iago Dillion Lima Cavalcanti, Master in Pharmaceutical Sciences, Specialist in Cancer Care and Palliative Care, Department of Biological Sciences – Universidade Federal de Pernambuco – UFPE, Recife, Brazil.

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety, and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that non-originator biologicals approved only outside of Europe might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Readers interested to learn more about the interchangeability of biosimilars are invited to visit to view the following manuscripts published in GaBI Journal:

Interchangeability of biosimilars in the US and around the world

USA and Europe differ in interchangeability of biosimilars

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Different approaches to the interchangeability of biosimilars

Interchangeability of biosimilars around the world


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1. Santos Soares JC, Cavalcanti IDL, de Albuquerque Vasconcelos JL. Can biosimilar products be interchangeable? Pharmaceutical perspective in the implementation of biosimilars in oncology. J Oncol Pharm Pract. May 2021. doi:10.1177/10781552211016099

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