In early 2021, Samsung Bioepic and Eden Biologics announced advances in the clinical trials of their respective ustekinumab and denosumab biosimilars.
Samsung Bioepis’ ustekinumab biosimilar
On 1 March 2021, Samsung Bioepis announced the start of a phase I clinical trial for its proposed biosimilar of Janssen’s Stelara (ustekinumab).
The ustekinumab originator has been approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and different forms of psoriatic arthritis.
Samsung’s latest phase I clinical trial for its SB17 (ustekinumab) biosimilar is a randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics (PK), safety, tolerability, and immunogenicity of Stelara and SB17 in healthy male volunteers. Samsung joins two other Korean biosimilars companies, Celltron Healthcare and Dong-A ST, in the development ustekinumab biosimilars [1]. It is hoped that the biosimilar products can be successfully approved for launch following expiration of Stelara’s patents in the US in 2023 and in Europe in 2024.
Samsung’s ustekinumab biosimilar is one of several undergoing clinical development by the company in 2021. One of these is SB16 (denosumab), a biosimilar of Amgen’s Prolia, a monoclonal antibody treatment for osteoporosis, which is undergoing simultaneous phase I and III trials [2, 3]. In addition, the phase III trials of SB11 (ranibizumab), a biosimilar of Genentech’s Lucentis used to treat certain types of eye disorder, demonstrated equivalence with the originator in November 2020 [3].
Eden Biologics’ denosumab biosimilar
Eden Biologics announced completion of enrolment for their phase I comparative PK clinical trial of their denosumab biosimilar (EB1001). The trial was a randomized, double-blind, parallel-group, single-dose, three-arm study which compared the biosimilar to Prolia in Australia and New Zealand [4]. The company plans to initiate the global phase III later in 2021.
A number of other biologicals companies are also developing denosumab biosimilars [4]. It is hoped that, together with those developed by Eden and Samsung, the denosumab biosimilars will enable increased access to this life-changing drug product.
Taiwan-based Eden Biologics was formerly JHL Biotech. The company changed its name on 19 February 2021, to reflect their commitment to produce affordable medicines for all patients in need and their evolving expertise in driving innovations needed to develop high-quality biologicals.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Korean biosimilars makers pipelines and expansion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Pharma-News/Korean-biosimilars-makers-pipelines-and-expansion
2. GaBI Online - Generics and Biosimilars Initiative. Samsung biosimilars denosumab clinical trials begin while rituximab development is halted [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/General/Samsung-biosimilars-denosumab-clinical-trials-begin-while-rituximab-development-is-halted
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar advances for Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-advances-for-Samsung-Bioepis
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-denosumab
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