Celltrion officially launched Zymfentra, also known as Remsima SC in Europe, in the U.S., last Friday.

Zymfentra is the world's only subcutaneous (SC) form of infliximab, having received FDA approval in October of the previous year. Under the approval, the drug can treat moderate to severe active ulcerative colitis and Crohn's Disease in adults, with a recommended dosage of 120mg every two weeks.

Set at a wholesale acquisition cost (WAC) of $6,181.08 for two doses, which covers a four-week period, Celltrion stressed that it has strategically priced Zymfentra considering its new drug status, competitive market prices for inflammatory bowel disease (IBD) treatments, and the unique characteristics of the U.S. pharmaceutical market.

With patents on the SC formulation and method of administration potentially extending until 2040, Celltrion expects that Zymfentra will enjoy long-term patent protection, securing stable revenue for the company.

According to IQVIA, the U.S. TNF-α inhibitor market was valued at approximately 62 trillion won ($46.5 billion) in 2022, with the IBD segment alone accounting for 12.8 trillion won.

Aiming to achieve a prescription rate of over 10 percent among the target patient population by 2025, two years post-launch, Celltrion envisions Zymfentra becoming a global blockbuster product with annual sales exceeding 1 trillion won.

The company plans to sell Zymfentra directly through its U.S. subsidiary, embarking on aggressive marketing campaigns to penetrate the market.

Early indications of its expanding prescription base come from multiple medium-sized Pharmacy Benefit Managers (PBMs) who have recognized Zymfentra's competitiveness and added it to their formulary without separate negotiations.

Moreover, Celltrion anticipates further enhancing Zymfentra's market presence by negotiating with major PBMs for preferred medication listings within the second quarter.

The company also intends to participate in medical conferences in the U.S. this year to communicate the product's competitive advantages to healthcare professionals directly and to run support programs offering discounts and supplies for patients with insufficient insurance coverage.

"Infliximab is already an established treatment for IBD patients, with proven efficacy and safety in Europe and around the world," Celltrion USA CCO Thomas Nusbickel said. "The availability of Zymfentra in the U.S. gives patients more flexibility in managing their disease with a convenient treatment option that delivers not only therapeutic efficacy, but also convenience."

The U.S. medical community and patients alike have expressed excitement about Zymfentra's release, given its convenience for home administration.

"IBD patients prefer treatments that are safe, effective and easy to dose," Icahn School of Medicine at Mount Sinai Professor Jean-Frederic Colombel said. "With the launch of Zymfentra in the U.S., patients will have more flexibility and convenience in managing their disease on a daily basis."

Crohn's & Colitis Foundation President Michael Osso also said, "IBD is a chronic and challenging disease, and the burden of abdominal pain, diarrhea, and bleeding is significant for patients."

Zympentra expands treatment options for IBD patients in the U.S., which is a significant advancement because it can be easily self-administered at home, Osso added.