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News - Celltrion Secures First-Ever U.S. Interchangeability Status for Truxima (rituximab) Biosimilar

July 2026 | Jack Overell – Head of Production, SAE Media Group

Celltrion has announced that it has obtained interchangeability status from the U.S. Food and Drug Administration (FDA) for its blood cancer treatment Truxima (rituximab), becoming the first rituximab biosimilar to achieve the designation in the United States.

The milestone also secures for Truxima the period of exclusivity granted to the first interchangeable biosimilar in a given molecule, reinforcing the product's position in the world's largest pharmaceutical market. Truxima already holds all of the adult indications carried by its reference product, including non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA) and microscopic polyangiitis (MPA).

Interchangeability recognises that a biosimilar may be substituted for its reference medicine without the intervention of the prescribing clinician, on the basis that no clinically meaningful difference in efficacy or safety has been demonstrated. For Truxima, the designation provides a firmer evidentiary footing for prescribing and is expected to support wider patient access while helping to ease the cost burden of treatment.

Strengthening Prescriber Confidence

By confirming that Truxima can be used interchangeably with its reference product, the FDA's decision gives U.S. clinicians additional assurance when selecting the biosimilar. Celltrion expects the status to translate into greater prescribing confidence across both hospital and community settings, at a time when payers and providers continue to look to biosimilars to relieve pressure on drug budgets without compromising clinical outcomes.

The company also highlighted that the designation preserves Truxima's comparative advantage amid an evolving U.S. biosimilar regulatory landscape. Regardless of any future changes to how interchangeability is treated, Truxima remains the only rituximab biosimilar to have secured the status to date, a point of differentiation Celltrion believes will continue to support its competitiveness in the market.

Market Leadership in U.S. Rituximab

Truxima has established a strong commercial position since its U.S. launch. According to market data from IQVIA, the product held a 35.8% share of the U.S. rituximab market by prescription volume as of February this year, ranking first, the first time a Korean-developed biosimilar has led a U.S. market segment. That performance has come against competition from global pharmaceutical companies, including the originator product.

The commercial momentum is reflected in revenue. Celltrion reported that Truxima generated more than KRW 300 billion across North America last year, representing year-on-year growth of over 40%, and has become one of the company's core revenue drivers.

Building the Oncology Biosimilar Portfolio

Celltrion said it intends to use the interchangeability milestone to reinforce Truxima's competitiveness in the U.S. rituximab market and to strengthen the positioning of its wider portfolio of follow-on oncology biosimilars.

A Celltrion spokesperson said Truxima had already proven its competitiveness by reaching the top of the U.S. rituximab prescribing rankings, and that securing interchangeability further cemented its standing. The company added that, even against shifting U.S. regulatory trends, it would draw on Truxima's established clinical data and prescribing record to improve treatment access for patients and help reduce healthcare costs.

Outlook

For the biosimilars sector, Truxima's interchangeability designation is a further signal of the growing maturity and competitiveness of the U.S. market, and of the role well-established biosimilars can play in broadening access to complex biologic therapies. As regulators, payers and providers continue to weigh how best to encourage biosimilar uptake, Celltrion's achievement positions the company as a notable presence in the oncology biosimilar space heading into the second half of 2026.

Editor’s Corner



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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