Celltrion's said Zymfentra, its subcutaneous (SC)-form infliximab treatment, has started receiving reimbursement in the U.S.
Zymfentra, referencing the original drug Remicade, developed by Janssen, is designed to treat a range of conditions, including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult Crohn's disease and ulcerative colitis.
Unlike the original medication, Zymfentra is administered subcutaneously, simplifying patient compliance.
While the drug is approved as a biosimilar in EU (product name: Remsima SC) and other countries, the U.S. FDA approved the treatment as a new drug in October of last year.
After approval, the company had implemented a “Start Program" to supply the drug free-of-charge to some patients or through pre-approval requests by physicians, ensuring early access to Zymfentra without initial reimbursement.
The company has since secured placement in formularies through agreements with pharmacy benefit managers (PBMs), including Express Scripts.
The formalization of these reimbursement contracts, typically taking around three months, began last month.
With the reimbursement process now in place, Celltrion stressed that physicians can now prescribe Zymfentra, enabling patients to purchase it directly from pharmacies, thereby creating a sustainable supply chain.
Celltrion has achieved coverage for approximately 40 percent of the U.S. private insurance market through PBMs like ESI. The company is aiming to increase its coverage by finalizing contracts with more major PBMs.
The company stressed that it is now focusing its resources on maximizing Zymfentra sales.
According to IQVIA, a drug market research firm, the U.S. IBD market, which Zymfentra primarily targets, is valued at approximately 12.8 trillion won ($9.2 billion)
Celltrion aims to capture at least 10 percent of this market by 2025, with potential revenues exceeding 2 trillion won if current growth trends in patient conversion and registration from IV to SC formulations continue.
In line with its goal, the company plans to expand its dedicated sales team from 60 to 100 personnel to enhance its competitive edge and effectively respond to increasing inquiries from healthcare providers.
In addition to expanding its sales force, Celltrion will launch a consumer advertising campaign for Zymfentra starting in August. This campaign will include TV commercials across major networks and OTT platforms, as well as collaborations with influencers on social media channels like YouTube, aiming to increase brand awareness and drive prescriptions.
"With the reimbursement initiation, we have established a stable revenue-generating foundation and a successful supply chain system for Zymfentra,” a company official said. “We are focusing on expanding our sales force and launching media advertising campaigns to enhance local interest and prescriptions."
Thanks to the reimbursement news, Celltrion's share price showed an upward trajectory on Monday.
As of 11:37 a.m., the company's shares stood at 182,000 won, up 4.42 percent from the previous trading day.
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