Celltrion announced on the 28th that it revealed the results of the global Phase 3 interchangeability clinical trial between its autoimmune disease treatment drug Uplyma and its original drug Humira at the ‘2024 Fall Dermatology Conference (FCDC).’
FCDC is an international conference established by American dermatology specialists to promote knowledge sharing on psoriasis, skin cancer, and other skin diseases. This year marked its 44th session. The event was held over four days from the 24th to the 27th (local time) in Las Vegas, USA.
At this conference, Celltrion presented the global Phase 3 interchangeability clinical trial results between Uplyma and Humira in a poster format, conducted on 367 patients with moderate to severe plaque psoriasis. The same clinical results were also disclosed last month at the ‘2024 European Academy of Dermatology and Venereology (EADV),’ a prestigious European dermatology conference.
The clinical results showed that the pharmacokinetic characteristics between the multiple crossover dosing group of Uplyma and Humira and the Humira maintenance dosing group met the statistical equivalence criteria. Similarities were also confirmed in efficacy, safety, and immunogenicity.
Based on these results, Celltrion plans to obtain interchangeability approval from the U.S. Food and Drug Administration (FDA), which was applied for earlier this year, and to establish a tailored sales strategy to expand market share in the U.S. Since prescriptions in the U.S. are issued by generic name rather than brand name, product selection can be made at the pharmacist’s discretion or based on patient demand. Therefore, interchangeability certification based on product competitiveness is expected to positively influence the expansion of Uplyma prescriptions within the U.S. market.
Uplyma is Celltrion’s first high-concentration biosimilar of Humira. Compared to the low concentration version, the drug dosage was reduced by half, and citrate, which can cause pain, was removed. In the U.S., based on a dual pricing policy, Celltrion has signed listing contracts with major pharmacy benefit managers (PBMs) and expanded supply channels, marking the beginning of a full-scale growth phase.
Humira is a global blockbuster drug that recorded sales of $14.404 billion (approximately KRW 18.7252 trillion) as of last year. Of this, more than 84%, or $12.16 billion (approximately KRW 15.808 trillion), was sold in the U.S., the world’s largest pharmaceutical market.
A Celltrion official said, “Following Europe, we have once again proven the competitiveness of Uplyma by disclosing the interchangeability clinical results in the U.S. We will do our best to smoothly proceed with the remaining approval procedures to increase Uplyma’s accessibility in the global market and solidify its leading position.”
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
