Celltrion "Up to 5 Follow-up Biosimilar Approval Applications to be Completed Within the Year"

"Expanding to 11 Similar Product Lines by 2025"
Targeting a 100 Trillion Won Market

Celltrion announced on the 13th that it plans to complete global approval applications for up to five follow-up biosimilars by the end of this year and expand its biosimilar product portfolio to 11 by 2025.

Through this, the company aims to further strengthen its competitiveness in the biosimilar business by adding follow-up biosimilar pipelines to the existing six products, including Remsima, Truxima, Herzuma, RemsimaSC, Uplizna, and Vegzelma.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

Last month, Celltrion completed the European approval application for the Stelara biosimilar 'CT-P43'. Celltrion plans to sequentially apply for approval of CT-P43 in major global countries. According to IQVIA, a global pharmaceutical market research organization, the global ustekinumab market reached approximately 23 trillion KRW last year.

Earlier in April, the company completed the European marketing authorization application for the Xolair biosimilar 'CT-P39' and plans to apply for the U.S. marketing authorization for the Eylea biosimilar 'CT-P42' within the first half of the year. Through CT-P42, Celltrion will expand its portfolio into the ophthalmology disease area. Eylea's global sales reached approximately 12.68 trillion KRW last year.

The company explained that the clinical trials for the follow-up biosimilar pipelines are progressing smoothly. Last month, Celltrion submitted the Phase 3 clinical trial protocol (IND) for the new pipeline Ocrevus biosimilar 'CT-P53' to regulatory agencies in Europe and the U.S. Along with this, Phase 3 clinical trials are currently underway for Prolia biosimilar 'CT-P41' and Actemra biosimilar 'CT-P47'.

Celltrion intends to complete approval applications for biosimilar products currently in clinical trials by the end of this year as much as possible. Including products for which approval applications have already been completed this year, it will be possible to apply for global approval for up to five products within the year. As early as 2025, the company will be able to secure a total of 11 biosimilar product lines, including the six existing product groups. The global market size for the entire portfolio of 11 biosimilars is approximately 100 trillion KRW.

Celltrion expects that by building a large-scale product portfolio, it can maximize synergy effects in the distribution process and create an upward effect in global market sales.

Leap to a Biopharmaceutical Development Company... Securing Platforms and New Drug Technologies

While strengthening its biosimilar business, Celltrion also plans to continue efforts for new drug development in areas such as antibody-drug conjugates (ADC), bispecific antibodies, antibody drugs, and microbiomes.

To this end, the company continues open innovation with domestic and international companies in these fields and focuses on in-house research and development. Additionally, to discover new modalities, it is expanding its scope through the development of oral antibody therapeutics and oncolytic viruses, steadily advancing efforts for new drug development.

Recently, Celltrion signed a contract with the U.S. biotech company Lani Therapeutics for the development of oral adalimumab. This is the second collaboration following the contract for oral ustekinumab development signed earlier this year. Along with this, Celltrion is seeking partnerships for new drug development by collaborating with various domestic and international biotechs through ▲ antibody drug development partnerships ▲ oncolytic virus platform technology development contracts ▲ microbiome joint research and development contracts ▲ biomarker development joint research and development contracts.

The Celltrion Group also plans to consider global mergers and acquisitions (M&A) from a macro perspective to enhance business competitiveness and create synergy in new drug development.

A Celltrion official said, "We are expanding our pipeline through global approval applications and acquisitions of next-generation biosimilars and continuing efforts to strengthen the biosimilar business. We will also continue to secure platform technologies for discovering new modalities and develop new drugs, striving to leap beyond biosimilars to become a new drug development company."

This content was produced with the assistance of AI translation services.