Celltrion is intensifying efforts to expand sales of its autoimmune disease treatment, Zymfentra (Korean name: Remsima SC), in the United States. The company plans to continuously launch new autoimmune disease treatments in the U.S. market following Zymfentra, aiming to enhance its growth momentum.
Zymfentra is a biosimilar (replica of a biological drug) of the blockbuster medication Remicade, developed by Janssen, a subsidiary of Johnson & Johnson (J&J) in the pharmaceuticals institutional sector. It is a product that has converted the main ingredient, infliximab, from an intravenous (IV) formulation to a subcutaneous (SC) formulation.
Celltrion previously developed a biosimilar, Remsima, in an IV formulation, similar to Remicade. Later, it developed it into an SC formulation, which received approval in the U.S. as a new drug rather than a biosimilar and was launched last year.
Remsima SC has already achieved a 22% market share in Europe based on the fourth quarter of last year. In Germany and France, it commands a market share of 44% and 29%, respectively, solidifying its position as a representative treatment for autoimmune diseases.
According to the company, prescription reimbursement for Zymfentra will fully begin in the U.S. this year. In the U.S., prescription drug reimbursement is when insurers, pharmaceutical companies, or pharmacy benefit managers (PBM) reimburse some or all of the costs of prescribed medication to patients.
Unlike Europe, the U.S. only applies reimbursement to medications listed in formularies operated by insurers. For SC formulation treatments like Zymfentra, PBMs negotiate with pharmaceutical companies on behalf of insurers and determine whether to include the medications in formularies. Due to this characteristic, PBM contracts and formulary inclusion significantly impact drug sales performance in the U.S.
Zymfentra signed listing agreements with numerous PBMs, including the three major PBMs in the U.S. It has secured over 90% of the U.S. insurance market, establishing a foundation for expanding prescriptions. The company expects that 'considering the time needed for actual reimbursement to take effect, reimbursement for Zymfentra will officially begin this year.'
The prescription volume of Zymfentra is already on the rise. Lee Dal-mi, a researcher at Sangsangin Investment & Securities, noted, 'Since Zymfentra's current insurance quotation rate has reached 70%, it is expected to be reflected in revenue starting in the second quarter of this year.'
This year, in addition to Zymfentra, Celltrion plans to expand its product lineup for autoimmune disease treatments to include up to 11 products, such as Steqeyma (Remicade biosimilar) and Avtozma (Actemra biosimilar), to secure growth momentum.
Currently, Avtozma and the bone disease treatments Stoboclo and Osenvelt (Prolia-Xgeva biosimilar), and the allergy treatment Omlyclo (Xolair biosimilar) have received approval from the U.S. Food and Drug Administration (FDA), and the eye disease treatment Eydenzelt (Eylea biosimilar) has completed its application process.
A representative from Celltrion remarked, 'Leveraging the experience and achievements gained from launching Zymfentra last year, we plan to focus our marketing efforts this year to achieve significant visibility in our results.' They added, 'We will concentrate all of the company's resources to accelerate our leap toward becoming a global big pharmaceutical company.'