Biosimilars of pembrolizumab

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Biosimilars of pembrolizumab

Biosimilars/General | Posted 14/10/2022 4 Post your comment

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).

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

Comments (4)

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Posted 19/01/2024 by Abbt Zhang

patent expire date

@Will Roettger，thanks for your answer.
As I know, the patents package of the subcutaneous injection formulation of pembro contains at least US11633476B2, the application date of which is 2018-05-01, and the estimated expiration date is 2039-10-14 (PTA+531d). Which subcutaneous preparation patent did you refer to calculate the expiration date is 2036? Can you provide the patent number?

Posted 19/01/2024 by Abbt Zhang

patent expire date

Posted 16/01/2024 by Will Roettger

Pembrolizumab US LOE

@Abbt Zhang. I believe that they are assuming that the pembro sub cu (SC) formulation, which I believe is patent pending, is accepted. Not sure it will be due to the current political environment, if it is then that would extend the patent out to 2036.