Celltrion, "'Truxima' Safety and Efficacy Reconfirmed"

Clinical Results After 4 Years on Market Revealed at American Society of Hematology

Celltrion's blood cancer treatment biosimilar 'Truxima (generic name Rituximab)' (Photo by Celltrion)

[Asia Economy Reporter Chunhee Lee] Celltrion announced on the 13th that it revealed the safety and efficacy results of 'Truxima (generic name Rituximab),' a biosimilar developed for blood cancer treatment, from post-marketing surveillance (PMS) in South Korea at the 2022 American Society of Hematology (ASH) conference.

ASH is being held simultaneously in Louisiana, USA, and online for four days from the 10th to the 13th of this month (local time). Celltrion disclosed the clinical results of Truxima through a poster presentation on the 12th.

Truxima, developed as a biosimilar to Roche's 'Rituxan (MabThera),' received domestic sales approval from the Ministry of Food and Drug Safety in 2016. Subsequently, it obtained consecutive sales approvals from the European Medicines Agency (EMA) in the following year and the U.S. Food and Drug Administration (FDA) in 2018, successfully entering the global market.

In Europe, Truxima achieved a market share of 23.6% as of the second quarter, surpassing the original drug's share. In the U.S., it recorded a 27.6% market share as of the third quarter. According to IQVIA, a pharmaceutical market research firm, the global Rituximab market size was estimated at $5.921 billion (approximately 7.7447 trillion KRW) as of last year.

This clinical data covers 677 safety evaluation subjects who were administered Truxima in South Korea over four years from November 2016 to November 2020. Celltrion recruited patients across all approved indications domestically, including non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), Wegener's granulomatosis (WG), and microscopic polyangiitis (MPA), to confirm the safety and efficacy after Truxima administration.

The PMS results showed that Truxima demonstrated safety comparable to the original drug and the clinical trial results that led to Truxima's approval. The efficacy evaluated under real-world medical use conditions also showed excellent outcomes.

A Celltrion official stated, “Through this PMS, we revalidated the safety and efficacy of Truxima across all indications,” adding, “Based on these positive clinical data, we expect the prescription of Truxima to expand, allowing more patients to receive medical benefits at reasonable prices.”

This content was produced with the assistance of AI translation services.