China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 23 February 2022 that it had entered into a licensing and supply agreement with Pakistan-based Getz Pharma for its adalimumab copy biological, Handa Yuan (汉达远; HLX03).
Under the terms of the agreement, Getz Pharma will be granted a licence to commercialize HLX03 in Pakistan, the Philippines, Vietnam, Cambodia, Myanmar, Nigeria, Kenya, Sri Lanka, Ukraine, Kazakhstan and Uzbekistan, as well as other territories, where agreed.
Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis, and ulcerative colitis.
HLX03 was approved by China’s National Medical Products Administration (NMPA) in December 2020 for the treatment of rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis in China and is the first product from Henlius to be approved for the treatment of autoimmune diseases [1].
Henlius has three copy biologicals approved in China. The company has also gained NMPA approval for its rituximab biosimilar Hanlikon (HLX01) [2], the first China-developed copy biological following the new guidelines [3], and for its trastuzumab biosimilar Han Quyou (HLX02) [4].
Zercepac (HLX02) was also approved in Europe in July 2020, making it the first China-developed monoclonal antibody biosimilar to be approved in the region [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. China approves adalimumab copy biological HLX03 biosimilar from Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 1]. Available from: www.gabionline.net/biosimilars/news/China-approves-adalimumab-copy-biological-HLX03
2. GaBI Online - Generics and Biosimilars Initiative. China approves rituximab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 1]. Available from: www.gabionline.net/Biosimilars/News/China-approves-rituximab-copy-biological
3. GaBI Online - Generics and Biosimilars Initiative. Chinese guidelines for copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 1]. Available from: www.gabionline.net/Guidelines/Chinese-guidelines-for-copy-biologicals
4. GaBI Online - Generics and Biosimilars Initiative. Copy biologicals approved in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 1]. Available from: www.gabionline.net/biosimilars/general/copy-biologicals-approved-in-china
5. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Zercepac [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 1]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Zercepac
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