China approves Simcare’s cetuximab beta Enlituo

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China approves Simcare’s cetuximab beta Enlituo

Biosimilars/News | Posted 30/07/2024 0 Post your comment

On 25 June 2024, Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group based in Nanjing, China, announced that Enlituo, a cetuximab beta injection, had received marketing approval from the China National Medical Administration (NMPA). This new-generation anti-epidermal growth factor receptor (EGFR) antibody drug was developed in collaboration with Mabpharm Limited.

Enlituo is a copy biological referencing Merck/Eli Lilly’s Erbitux. This cetuximab beta is classified as a 2.4 class modified biological new drug.

Cetuximab is a chimeric (mouse/human) monoclonal antibody. It inhibits EGFR epidermal growth factor receptor (EGFR) and is used to treat metastatic colorectal cancer, metastatic non-small cell lung cancer, and head and neck cancer [1].

In China, Enlituo is indicated for use in combination with the Folfiri regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC). Mabpharm has obtained exclusive commercial rights of Enlituo in mainland China.

Enlituo received approval based on robust evidence from a phase II/III study and a phase III confirmatory clinical trial. In an open-label, randomized, controlled, multicentre, prospective phase III study, 505 subjects with RAS/BRAF wild-type mCRC were treated and analyzed. Clinical data revealed that combining cetuximab beta with Folfiri significantly extended progression-free survival (PFS) compared to Folfiri alone (13.133 months vs 9.567 months, p = 0.004). Additionally, the combination increased the objective response rate (ORR) (69.1% vs 42.3%, p < 0.001) and overall survival (OS) (2.322 years vs 1.900 years, p = 0.024).

According to the 'Cancer Incidence and Mortality in China, 2022' report by the National Cancer Center, colorectal cancer is the second most common cancer in China. Annually, there are 1,571 million new cases and 240,000 deaths. As such, the approval of Enlituo is significant for patients and for reducing the societal disease burden of colorectal cancer.

Back in 2017, biotech giant Amgen and Simcere entered into an exclusive agreement to co-develop and commercialize four copy biologicals in the areas of inflammation and oncology in China [2].

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 copy biologicals approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Positive phase III results for cetuximab and infliximab copy biologicals

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of cetuximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-cetuximab
2. GaBI Online - Generics and Biosimilars Initiative. Amgen and Simcere to collaborate on copy biologicals in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 30]. Available from: www.gabionline.net/pharma-news/Amgen-and-Simcere-to-collaborate-on-copy-biologicals-in-China

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