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) . AVT02 has already received approval in many countries across the world as a high-concentration low-volume version of adalimumab, including Europe , Japan, Canada and Switzerland , 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) .
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 .
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.
Humira (adalimumab) biosimilars pipeline
Switching from adalimumab originator and ABP501 to SB5 in arthritis patients
Canada approves ranibizumab biosimilar Byooviz
Phase III trial evidence used in approval of ranibizumab biosimilar Byooviz
Fresh partnerships announced for ranibizumab and trastuzumab biosimilars
LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.
View the latest headline article: Hechos clave en la regulación de la aprobación de biosimilares en Brasil
Browse the news in the Latin American Forum!
Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.
Ver el último artículo de cabecera: Hechos clave en la regulación de la aprobación de biosimilares en Brasil
!Explore las noticias en el Foro Latinoamericano!
Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.
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:
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:
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:
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
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.
Post your comment