Celltrion’s blood cancer treatment, Truxima (rituximab), has maintained its top position in the U.S. rituximab market for four consecutive months, solidifying its market dominance. The drug recently became the first biosimilar to receive interchangeability status from the U.S. Food and Drug Administration (FDA), sparking optimism for further growth.
On Tuesday, Celltrion announced that Truxima captured a 38.6% market share in May, according to data from IQVIA, a healthcare analytics firm. This marks the fourth straight month since February that Truxima has been the most prescribed rituximab product in the U.S.
The May figure represents a 2.8 percentage point increase from February when Truxima first claimed the top spot. Celltrion also noted that the gap between Truxima and its competitors, including the original drug, has widened.
Truxima is the first Korean biosimilar to lead the U.S. market in its category. Its success in outperforming products from global pharmaceutical giants in the world’s largest drug market is seen as a testament to its competitiveness.
The growth trajectory is expected to continue. In early July, Truxima became the first rituximab biosimilar to secure FDA interchangeability status. This designation allows pharmacists to substitute Truxima for the original drug without consulting the prescribing physician.
Celltrion anticipates that this new status will accelerate Truxima’s penetration into the roughly 20% market share still held by the original drug.
Other Celltrion biosimilars are also gaining ground in the U.S. market. Inflectra (infliximab), used to treat autoimmune diseases, held a 30.4% market share in May, maintaining its strong position. Other products in the company’s portfolio, including biosimilars for Stelara, Avastin, and Humira, captured market shares of 13.3%, 10.6%, and 8.1%, respectively.
Building on this momentum, Celltrion plans to launch new products in the second half of the year. Its U.S. subsidiary is set to introduce Avtozma (tocilizumab SC) and Omirclo (omalizumab), both treatments for autoimmune diseases. The company aims to leverage its established pharmacy benefit manager (PBM) network to facilitate the market entry of these new offerings.
A Celltrion spokesperson stated that capitalizing on the success of key products like Truxima, it’s committed to securing early market entry for our high-potential pipeline products slated for release later this year.
In other news, Celltrion recently maintained its top AAA rating in the Korean Customs Service’s renewal review for Authorized Economic Operator (AEO) status.
The AEO program is an international standard certification system. Customs agencies evaluate companies based on their compliance with laws, internal control systems, financial stability, and safety management practices, in line with World Customs Organization standards.
Celltrion is one of only 20 companies to hold the highest AAA rating among 773 AEO-certified firms in Korea. Notably, it stands as the sole pharmaceutical and biotech company to achieve this top-tier rating.