Australia and EU: Alvotech Humira and Stada Lucentis biosimilars approved

In November 2022, Alvotech announced that the Therapeutic Goods Administration (TGA) of Australia has granted marketing authorization for its a high-concentration low-volume adalimumab, AVT02, a biosimilar referencing Humira and marketed by their partner, Cipla Australia. In addition, Stada Arzneimittel and Xbrane Biopharma announced that the European Commission granted marketing authorization for their Ximluci (ranibizumab), a biosimilar candidate referencing Lucentis.

Alvotech’s AVT02 in Australia
Adalimumab, sold under the brand name Humira, is a monoclonal antibody used to treat a range of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis and inflammatory bowel disease (IBD) [1]. AVT02 has already received approval in many countries across the world as a high-concentration low-volume version of adalimumab, including Europe [2], Japan, Canada and Switzerland [3], under different partnerships (including one with Stada) and with brand names including Hukyndra, Libmyris and Simlandi.

Now, in Australia, AVT02 is to be marketed in partnership with Cipla. It will be available as a 40 mg/0.4 mL and 80 mg/0.8 mL solution in a pre-filled syringe and 40 mg/0.4 mL solution in a pre-filled pen; and marketed as Ciptune and Ardalicip respectively. The product has been approved for indications including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease in adults and children (≥ 6 years; weighing ≥ 40 kg), ulcerative colitis, psoriasis in adults and children, hidradenitis suppurativa in adults and adolescents (from 12 years of age) and uveitis.

Stada’s Ximluci in Europe
Stada announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Ximluci in September 2022. Now this product has also received marketing authorization from the European Commission and the 10 mg/mL solution for injection can be used in treatment of wet age-related macular degeneration (AMD), diabetic macular oedema (DMO), diabetic retinopathy (PDR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV) [4].

Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. It inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A). Ranibizumab can be used to treat macular degeneration by inhibiting VEGF, which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. The monoclonal antibody drug is indicated for the treatment of wet AMD, macular oedema, degenerative myopia and diabetes complications; all conditions of the eye causing vision loss [5].

Stada and Xbrane entered into an agreement in 2018 under which the two companies are jointly responsible for development and for manufacturing Ximluci. Stada now holds the marketing authorizations and the commercial rights to the biosimilar across all territories included in the agreement, which covers Europe, the US, several countries in the Middle East and North Africa (MENA) region, and selected Asia-Pacific (APAC) markets. The partners are preparing to launch the product in Europe, which includes Iceland, Norway and Liechtenstein, in early in 2023.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 25]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of two adalimumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 25]. Available from:
www.gabionline.net/biosimilars/news/ema-recommends-approval-of-two-adalimumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Advances for Alvotech’s partnerships in Japan, Canada and Switzerland [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 25]. Available from:
www.gabionline.net/biosimilars/news/advances-for-alvotech-s-partnerships-in-japan-canada-and-switzerland
4. GaBI Online - Generics and Biosimilars Initiative. Progress for Lucentis (ranibizumab) biosimilars in Europe and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 25]. Available from:
www.gabionline.net/biosimilars/news/progress-for-lucentis-ranibizumab-biosimilars-in-europe-and-the-us
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 25]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab

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