Celltrion to expand biosimilar portfolio to 11 by 2025
Jeong Min Nam
Jun 13, 2023 (Gmt+09:00)
South Korea's biopharmaceutical company Celltrion Inc. announced on Tuesday that it plans to beef up its portfolio by applying for regulatory approval for five additional biosimilars by the end of the year.
Celltrion aims to bring its total biosimilar offering to more than ten by 2025, a significant increase from its current roster of six.
By May 2023, Celltrion had already submitted approval applications for two of these follow-on biosimilars. The company reported that it had lodged a European application for its CT-P43, a biosimilar of Janssen's Stelara, in May, and for the CT-P39, a biosimilar of Omalizumab in April.
Plans are underway for a US approval application for CT-P42, a biosimilar of Regeneron’s ocular drug, Eylea, set for the first half of this year.
Further down the pipeline, clinical development is progressing apace. Last month, Celltrion forwarded a clinical trial plan to both European and US regulatory authorities for phase 3 trials of its CT-P53, a biosimilar of the multiple sclerosis medication, Ocrevus.
In other development milestones, the company's CT-P41, a biosimilar to Amgen Prolia, and the CT-P47, a biosimilar of the rheumatoid arthritis medication Actemra, are currently in phase 3 trials. Celltrion aims to expedite these clinical trials and wrap up the approval application process by year-end.
Securing these five additional biosimilar pipelines could potentially grant Celltrion access to a new market worth 50 trillion won ($39 billion), augmenting the 50-trillion-won market already tapped by the firm's six existing products. This could see Celltrion targeting a total global market of 100 trillion won ($78 billion).
Observers note that the firm's diversification strategy could bolster its competitive edge in the global biosimilar market. Through building an expansive product portfolio, Celltrion may significantly enhance synergy effects in its distribution process.