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).


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.

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pembrolizumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 14]. Available from:
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 []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 14]. Available from:
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 14]. Available from:

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