Korean biosimilars makers have started conducting global clinical trials and are expanding into other markets with their biosimilars.
Korean biosimilars makers are targeting blockbuster biologicals that are expected to lose patent protection between 2022‒2025, such as Prolia (denosumab) and Stelara (ustekinumab), as well as those with patents already expired, such as Herceptin (trastuzumab) , see Table 1.
| Table 1: Ongoing clinical trials for Korean biosimilars
|| Active substance
|| Trial start/end
|| Planned launch dates
| Celltrion Healthcare
|| Jan 2021/ Sep 2022
| Celltrion Healthcare
|| Oct 2020/ May 2021
| Dong-A ST
|| 1Q 2021/-
Sep 2023 (US)
Jul 2024 (EU)
| Prestige Biopharma
|| Jan 2018/ Mar 2022
| Samsung Bioepis
|| Nov 2020/ Mar 2023
| EU: European Union; US: United States of America.
Dong-A ST announced that it had received approval from the US Food and Drug Administration to start a phase III trial of ustekinumab in the first quarter of 2021 and will seek approval for the biosimilar in both the US and in nine countries in Europe.
Celltrion Healthcare (Celltrion) is preparing to launch denosumab and ustekinumab biosimilars once the patents on Prolia and Stelara expire. Celltrion’s phase III trial for CT-P43 (ustekinumab) is expected to be completed in September 2022. While for CT-P41 (denosumab) a phase I trial is ongoing, and the company plans to complete a phase III trial in 2024.
Samsung Bioepis started a global phase III trial comparing the safety and efficacy of SB16 (denosumab) to Prolia in November 2020. The company also has a phase I trial testing the pharmacokinetics, safety and immunogenicity of SB16 in healthy volunteers running in parallel, which is expected to be completed in August 2021 .
Singapore-based Prestige Biopharma, which has good manufacturing practice (GMP) facilities in Korea, has conducted global phase III trials of HD201 (trastuzumab) in 13 countries. It has reported positive results that, according to Prestige, ‘confirm the similarities between HD201 and trastuzumab’ . The company announced in May 2019 that the application for its proposed trastuzumab biosimilar Tuznue (HD201) had been accepted by the European Medicines Agency .
Prestige also announced in January 2021 that it had signed a contract with Saudi Arabia-based Tabuk Pharmaceuticals for HD201, obtaining a license for some regions, including Saudi Arabia and the United Arab Emirates, of the Middle East and North Africa.
Biosimilars approved in South Korea
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1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-denosumab
3. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for trastuzumab biosimilar HD201 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 26]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-trastuzumab-biosimilar-HD201
4. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilar from Prestige accepted for review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 26]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-biosimilar-from-Prestige-accepted-for-review-by-EMA
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Source: ClinicalTrials.gov, Korea Biomedical Review