New partnerships for Cipla and Samsung Bioepis Posted 09/04/2021

In March 2021, Cipla announced that its subsidiary, Cipla Gulf is expanding its partnership with Alvotech for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. Samsung Bioepis also announced that it has signed a marketing partnership with Yuhan to launch its biosimilar of Humira (adalimumab), Adalloce, in South Korea.

Cipla Gulf-Alvotech partnership
Under this new Cipla Gulf-Alvotech partnership, Cipla will be responsible for commercialization of patented biosimilar products developed and manufactured by Alvotech, in Australia and New Zealand. The products are biosimilars of the originators Aflibercept (Eylea®️), Ustekimumab (Stelara), Denosumab (Prolia, Xgeva®️) and Golimumab (Simponi®️), and are used to treat conditions across immunology, osteoporosis, oncology and ophthalmology. The company revealed that together, these products reached sales of US$700 million in 2020 in Australia alone.

This strategic alliance follows a previous agreement between the two companies in 2019. This led to the commercialization of AVT02, another biosimilar of AbbVie’s Humira (adalimumab), in select emerging markets [1]. In November 2020, Alvotech announced its US subsidiary had filed for the approval of AVT02 and that the European Medicines Agency (EMA) had accepted its AVT02 application for review [2].

Samsung Bioepis-Yuhan partnership
The Samsung Bioepis-Yuhan partnership will see the first biosimilar version of Humira available in South Korea.

Humira is the world's No. 1 drug in terms of sales (US$20 billion in 2018 [1]). It is used to treat autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis and Crohn's disease.

Under the terms of the partnership, Samsung Bioepis will be responsible for the domestic sales of three different types of biosimilars developed based on the blockbuster antitumour necrosis factor alpha drugs: Humira, Remicade and Enbrel.
Samsung Bioepis has estimated that the Korean market for the three biosimilars is around US$176 million.

Samsung Bioepis first received approval for the sale of Adalloce in Korea in 2017 [3]. It then held patent negotiations with AbbVie, the manufacturer of Humira, to be able to release Adalloce in Korea. Adalloce is expected to go on sale in Korea in the first half of 2021, at retail prices 20 to 30 per cent lower than those of Humira.

Adalloce was released as Imraldi in Europe in October 2018 and by the end of 2020, cumulative sales were in the region of US$417 million. The product is due to go on sale as Hadlima in the US and sales will begin under patent contract with AbbVie in 2023.

Related articles
Latest launches for adalimumab biosimilars in Canada and Japan

Biosimilar advances for Samsung Bioepis

Biosimilars approved in Australia

LATIN AMERICAN FORUM – Coming soon!

To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

 

LATIN AMERICAN FORUM – Próximamente!

Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

References
1. GaBI Online - Generics and Biosimilars Initiative. Alvotech and Cipla Gulf partnership announced [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Pharma-News/Alvotech-and-Cipla-Gulf-partnership-announced 
2. GaBI Online - Generics and Biosimilars Initiative. EMA and FDA accept application for adalimumab biosimilar AVT02 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Biosimilars/News/EMA-and-FDA-accept-application-for-adalimumab-biosimilar-AVT02 
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea 

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