Celltrion today shipped the first U.S. shipments of Zymfentra (Ramsima SC in the U.S.), the world's only subcutaneous injectable formulation of infliximab, kicking off the company's U.S. market launch.
Celltrion will ship the initial batch of Zymfentra in three shipments between today and early March, with the first shipment departing today via air to Atlanta, Georgia. This shipment is expected to be available to the market in mid-March, pending completion of local logistics, including import customs clearance and transportation, and wholesale and retail stocking. All of this initial shipment will be supplied as finished product and ready for immediate sale.
Zymfentra is a subcutaneous formulation of Ramsima, which was developed to meet the needs of global healthcare providers and patients and was approved by the U.S. Food and Drug Administration (FDA) as a new drug in October of last year.
Zymfentra is currently licensed in more than 50 countries, including Europe and Canada, under the brand name Ramsima SC, and has demonstrated therapeutic efficacy and convenience in the European market, with high potential for success in the U.S., the world's largest pharmaceutical market.
The European market has been expanding since the launch of Ramsima SC in 2020, with favorable reviews from healthcare providers and patients. According to pharmaceutical market research firm IQVIA, Ramsima SC had a 20% market share in the EU5 as of the third quarter of last year, with a combined share of 72% with Ramsima.
Celltrion has been preparing for direct marketing in the U.S. since Zymfentra was approved by the FDA as a new drug in October last year. The strategy is to emphasize Zymfentra's strengths, including its ability to be self-administered, given that Infliximab has been used in the U.S. for more than 20 years and is well established in terms of efficacy and safety, and the relatively high economic and physical barriers to healthcare facilities.
In addition, the pending patents for the SC formulation and administration will provide patent protection up to 2040, and the new drug status will allow Zymfentra to command a higher selling price than biosimilars, providing a stable revenue base.
According to IQVIA, the IBD disease market that Zymfentra is targeting is estimated to be worth approximately $9.827 billion (12.8 trillion KRW) in 2022 for TNF-α inhibitors alone, and the potential target IBD market expands to approximately $21.8 billion (28.3 trillion KRW) when non-TNF-α therapies are included.
"This initial shipment marks the beginning of Zymfentra's supply to the U.S. market," said an official from Celltrion. "As clinician and patient excitement for Zymfentra continues to grow, we are finalizing various launch marketing activities, including patient support programs, to ensure that U.S. patients are able to benefit from Zymfentra."
