In May 2024, Klinge Biopharma announced an exclusive licensing and supply agreement with MS Pharma for FYB203 commercialization in the Middle East and North Africa (MENA) region. Previously, in April 2024, mAbxience and Teva Pharmaceuticals signed a strategic licensing agreement for a biosimilar candidate for oncology treatment.
Klinge–MS Pharma
On 15 May 2024, it was announced that Klinge Biopharma, licensee and exclusive holder of the worldwide commercialization rights for FYB203, Formycon’s biosimilar candidate to Eylea (aflibercept), has entered into an exclusive licensing and supply agreement with MS Pharma for the commercialization of FYB203 in the MENA region.
MS Pharma is a leading regional pharmaceutical company in the MENA region. The company is also marketing Formycon’s ophthalmic Lucentis biosimilar FYB201 in the region.
Aflibercept is an ophthalmology product, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is a vascular endothelial growth factor (VEGF) inhibitor [1], a recombinant fusion protein consisting of human VEGF receptor 1 and VEGF receptor 2 extracellular domains fused to the Fc portion of human IgG1 which acts as a soluble decoy for the natural VEGF receptors that inhibits their activation, thereby reducing pathological angiogenesis.
The FYB203 biosimilar underwent clinical trials that ended in 2023. Klinge also entered into a partnership with Coherus BioSciences for commercialization of the biosimilar in the US [2].
Teva–mAbxience
In April 2024, mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, and Teva Pharmaceuticals International entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications.
The Teva–mAbxience licensing agreement covers multiple global markets, including Europe and the US.
Under the terms of the licensing agreement, mAbxience will leverage its expertise in biosimilar development and its state-of-the-art, current good manufacturing practice (cGMP)-approved facilities in Spain and Argentina, to develop and produce the biosimilar product. Teva will lead the regulatory processes and commercialization in the designated regions, to ensure access to a broader patient population.
This move is part of mAbxience’s global expansion strategy. It has already joined forces with Biosidus to manufacture Agalsidase Beta, a biosimilar of Fabrazyme and a treatment for Fabry disease [3]. In addition, they entered into an agreement with Abbott to commercialize biosimilars in Latin America and emerging markets [4], and with HK inno.N to bring a denosumab biosimilar to market in South Korea [2].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 5]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-aflibercept
2. GaBI Online - Generics and Biosimilars Initiative. HK inno.N–mAbxience partnership in Korea and Coherus advances in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 5]. Available from: www.gabionline.net/pharma-news/hk-inno.n-mabxience-partnership-in-korea-and-coherus-advances-in-the-us
3. GaBI Online - Generics and Biosimilars Initiative. mAbxience and Biosidus sign an agreement to manufacture Agalsidase Beta [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 5]. Available from: www.gabionline.net/pharma-news/mabxience-and-biosidus-sign-an-agreement-to-manufacture-agalsidase-beta
4. GaBI Online - Generics and Biosimilars Initiative. Abbott and mAbxience partnership for biosimilars in emerging markets [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 5]. Available from: www.gabionline.net/pharma-news/abbott-and-mabxience-partnership-for-biosimilars-in-emerging-markets
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