Meitheal expands portfolio with three biosimilars through exclusive US licensing agreement

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On 31 October 2024, it was announced that Chicago-based Meitheal Pharmaceuticals had expanded its biosimilars portfolio with an exclusive commercial licensing agreement with its parent company, Hong Kong King-Friend Industry Co, to market and distribute three biosimilars in the US. These include the oncology biosimilars pegfilgrastim and filgrastim, as well as fertility treatment follitropin alpha. 

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Follitropin alpha is a form of recombinant human follicle-stimulating hormone and is used to in fertility treatment to stimulate follicle development in women and spermatogenesis in men. At time of reporting, there are no biosimilars for the gonadotropin follitropin alpha available in the US.  

Pegfilgrastim and filgrastim are bone marrow stimulants that support white blood cell production for patients receiving certain cancer treatments. The medications are recombinant human granulocyte colony-stimulating factor (G-CSF) analogues, with pegfilgrastim being a PEGylated form of filgrastim. Treatment with both products can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy [1]. 

Filgrastim is dosed subcutaneously or intravenously daily for up to 14 days during a chemotherapy treatment cycle. Pegfilgrastim is longer-acting and is dosed subcutaneously once per treatment cycle. IQVIA September 2024 data estimate that the US market for pegfilgrastim and filgrastim is estimated at over US$2.5 billion.

This agreement means that Meitheal’s total biosimilar portfolio now extends to eight biosimilars across diabetes, oncology, fertility, and autoimmune indications. They have also entered into other strategic partnerships, such as with China’s Tonghua Dongbao to commercialise insulin biosimilars in the US [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 20]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-pegfilgrastim
2. GaBI Online - Generics and Biosimilars Initiative. Insulin biosimilars: new CRL for Biocon, new deal for Meitheal/Tonghua Dongbao [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 20]. Available from: www.gabionline.net/pharma-news/insulin-biosimilars-new-crl-for-biocon-new-deal-for-meitheal-tonghua-dongbao

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