Biosimilars of pembrolizumab

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Pembrolizumab is a humanized (from mouse) monoclonal antibody that binds to, and blocks PD-1 located on lymphocytes. It is an anticancer medication used in the treatment of melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, urothelial cancer (cancer of the bladder and urinary tract) and renal cell carcinoma (kidney cancer).

Cancer image015

The originator product, Merck Sharp & Dohme’s Keytruda (pembrolizumab), was approved by the US Food and Drug Administration (FDA) on 4 September 2014 and on 17 July 2015 by the European Medicines Agency (EMA) [1]. Keytruda had worldwide sales of US$14.4 billion in 2020, making it a lucrative target for biosimilars developers, see Table 1.

The patents on Keytruda expire in the US in November 2036 and in Europe on 13 June 2028 [1]. Some of the pembrolizumab biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of pembrolizumab approved or in development
Company name, Country Product name Stage of development
BioXpress Therapeutics, Switzerland - In pipeline
DM Bio, South Korea - In pipeline
Formycon - In pipeline
NeuClone/Serum Institute of India, Australia/India - Preclinical. NeuClone and Serum Institute of India have agreed to co-develop 10 biosimilar monoclonal antibodies.
PlantForm/PlantPraxis Biotecnologia/ Bio-Manguinhos/ Fiocruz (ANVISA, Brazilian Health Regulatory Agency), Canada/Brazil* - In pipeline
*See editor’s comment.

  

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 ‘biosimilares’ approved in Brazil might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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Reference
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003

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Source: EMA, MSD, US FDA

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