Forwards for Formycon’s Keytruda and backwards for Prestige’s Herceptin

Biosimilars/News | Posted 14/10/2022 post-comment0 Post your comment

On 19 September 2022, Formycon announced details of a project to produce a biosimilar of Keytruda (pembrolizumab). This followed news that, on 16 September 2022, Prestige Biopharma withdrew the Marketing Authorization Application (MAA) for their Herceptin Biosimilar, Tuznue, submitted to the European Medicines Agency (EMA).

MD002152

Formycon’s Keytruda biosimilar
Keytruda (pembrolizumab) was developed by Merck. It 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) [1].

Keytruda was approved by the US Food and Drug Administration (FDA) in September 2014 and by EMA in July 2015 [1] and its patents in these regions are due to expire in 2028 [2].

The market for Keytruda was reported to be more than US$17 billion worldwide in 2021 [3]. Formycon’s biosimilar version, FYB206, is currently in the preclinical stages of development and development and commercialization rights are fully owned by Formycon. The company has already created important intellectual property (IP) related to the product and patent applications have been filed, with data from the development of alternative formulations.

The company has reported convincing results from the analytical protein characterization and progress in the development of the manufacturing process. As such, Formycon is in the process of compiling a comprehensive data package to closely align further programme steps in Scientific Advice Meetings with EMA and FDA later in 2022. In addition, they will be adjusting the manufacturing process to commercial scale and has already secured good manufacturing practice (GMP) capacities at a contract manufacturer.

Prestige’s Herceptin biosimilar
Prestige received a negative opinion on the marketing authorization for Tuznue and Hervelous (HD201) on 9 May 2022 [4] from EMA’s Committee for Medicinal Products for Human Use (CHMP). This occurred due to product ‘drift’ which surrounds changes in the manufacturing process of Tuznue during the phase III study of the biosimilar. On 23 May 2022, Prestige requested re-examination on the MAA, however, the CHMP again delivered a negative opinion due to disparity in the range of acceptance for the criteria of analytical comparability between the clinical testing batch and commercial production batch of Tuznue.

The biosimilar was to be marketed as Hervelous in Belgium and Tuznue in the other EU member nations.

As such, Prestige has withdrawn its application and plans to reapply after supplementing data through additional tests and analysis to meet CHMP’s criteria of analytical comparability.

Roche’s originator trastuzumab biological (Herceptin) was approved by FDA in 1998 and by EMA in 2000. The patents on Herceptin expired in Europe in July 2014 and in the US in June 2019 [3] and many biosimilar versions have since entered the market [5].

Trastuzumab is a monoclonal antibody that binds to and inactivates the human epidermal growth factor receptor 2 (HER2)/neu receptor and is used to treat HER2 positive (HER2+) breast cancers [5] and gastric cancer.

Related articles
PlantForm and partners in Brazil to develop pembrolizumab biosimilar

Merck to create spin off for women’s health and biosimilars

LATIN AMERICAN FORUM

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Recomendaciones para mejorar la regulación de los biosimilares en América Latina

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

FORO LATINOAMERICANO

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Recomendaciones para mejorar la regulación de los biosimilares en América Latina

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

  

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pembrolizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 14]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-pembrolizumab
2. 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 
3. Keytruda revenue 2014-2021. Statista.
4. GaBI Online - Generics and Biosimilars Initiative. EMA authorizations: CRO generics suspended and Herceptin biosimilar refused [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 14]. Available from: www.gabionline.net/pharma-news/ema-authorizations-cro-generics-suspended-and-herceptin-biosimilar-refused
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 14]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-trastuzumab

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
FDA approves biosimilar pegfilgrastim Stimufend
Approved-V13G05
Biosimilars/News Posted 07/10/2022
EC approves bevacizumab biosimilar Vegzelma
Anaemia 2 V13J18
Biosimilars/News Posted 23/09/2022
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010