Celltrion’s YUFLYMA® Secures Full FDA Interchangeability Status Across All Approved Forms and Strengths, Reinforcing Market Leadership and Commitment to Affordable Biologics
Celltrion, Inc., a global biopharmaceutical company headquartered in South Korea, announced a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting an expanded interchangeability designation for its high-concentration biosimilar YUFLYMA® (adalimumab-aaty). The designation now covers all available dosage forms and strengths of the product, including the prefilled syringes (40mg) and autoinjectors (40mg and 80mg). This achievement confirms that YUFLYMA is fully interchangeable with the reference biologic, Humira® (adalimumab), for all FDA-approved presentations.
The FDA’s interchangeability status is highly coveted in the biosimilars landscape as it allows for pharmacy-level substitution of the biosimilar in place of the reference product without the need for intervention from the prescribing healthcare provider—subject to state laws. This expanded designation places YUFLYMA among the limited number of biosimilars in the U.S. market that meet this elevated regulatory standard, and even fewer that do so across all marketed forms and strengths.
A Major Step Forward in Biosimilar Adoption
YUFLYMA is a high-concentration, citrate-free biosimilar formulation of adalimumab. It is approved for the treatment of a wide array of inflammatory and autoimmune conditions, offering therapeutic options for patients diagnosed with diseases such as:
- Rheumatoid arthritis (RA)
- Psoriatic arthritis (PsA)
- Ankylosing spondylitis (AS)
- Ulcerative colitis (UC)
- Plaque psoriasis (Ps)
- Hidradenitis suppurativa (HS)
- Uveitis (UV)
- Crohn’s disease (CD) in adults and pediatric patients aged 6 years and older
- Juvenile idiopathic arthritis (JIA) in patients aged 2 years and older
These approvals mirror the range of indications granted to Humira, further solidifying YUFLYMA’s therapeutic equivalence in clinical application.
YUFLYMA’s latest milestone marks a turning point in the company’s broader strategic efforts to compete in the U.S. biosimilars market, particularly as the space heats up with numerous entrants seeking to challenge Humira’s decades-long market dominance. Since its U.S. launch in July 2023, Celltrion has positioned YUFLYMA as a strong competitor by emphasizing clinical parity, patient convenience, and affordability.
Clinical Data Validates Switchability and Efficacy
The FDA’s decision to expand YUFLYMA’s interchangeability designation is underpinned by robust clinical data from a pivotal Phase III study. This study examined the outcomes of patients with moderate to severe plaque psoriasis who either continued on the reference product, Humira, or alternated between Humira and YUFLYMA during treatment intervals.
Key findings from the trial showed no clinically meaningful differences in pharmacokinetics, efficacy, safety, or immunogenicity between the two patient groups. These results confirmed that patients can transition between the originator biologic and the biosimilar without compromising treatment outcomes. The study’s findings were presented at the European Academy of Dermatology and Venereology (EADV) Congress in September 2024 in the Netherlands, where it was well received by the medical and scientific community.
The interchangeability study is critical because FDA standards for such a designation are higher than those for biosimilarity alone. Interchangeable products must demonstrate that switching between the biosimilar and the reference product poses no greater risk than remaining on the reference product. With this validation, healthcare providers and pharmacists can now be more confident in recommending or dispensing YUFLYMA as a clinically proven substitute for Humira.
Commitment to Cost Reduction and Patient Access
In addition to its regulatory success, Celltrion has moved decisively to align its pricing strategy with broader federal and market efforts aimed at reducing drug costs. Effective immediately, the wholesale acquisition cost (WAC) for YUFLYMA has been reduced to $948 per syringe. This pricing update has already been reflected in national pricing databases, ensuring transparency and immediate applicability.
This move underscores Celltrion’s commitment to making biologics more affordable and accessible. As drug pricing continues to be a major concern for patients, providers, and policymakers alike, the company’s decision to lower the cost of its biosimilar offerings is expected to have a meaningful impact on healthcare budgets and patient out-of-pocket expenses.
“With this full interchangeability designation, we’re meeting a critical moment in the biosimilars market,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “YUFLYMA is a high-concentration, citrate-free adalimumab biosimilar that’s now interchangeable with Humira across all marketed forms. Our decision to reduce the list price is an extension of our long-standing commitment to improving affordability, enhancing access, and putting patients first.”
Dual Branding and Flexible Pricing Model
In order to meet a diverse range of patient and payer needs, Celltrion offers YUFLYMA in both branded and unbranded formats. This approach enables the company to tailor its pricing and reimbursement strategy depending on the clinical setting, insurance coverage, and purchasing channel.
Currently, YUFLYMA is available in multiple presentations, including:
- 20mg, 40mg, and 80mg solution for injection in prefilled syringes
- 40mg and 80mg autoinjectors
These options allow clinicians and patients to select the most suitable formulation based on patient preference, disease severity, and treatment administration convenience. The inclusion of both autoinjectors and prefilled syringes caters to a broad patient demographic, from younger individuals to older adults who may have difficulties with manual dexterity.
Implications for the Broader Biosimilar Landscape
Celltrion’s achievement comes at a pivotal time in the evolution of the U.S. biosimilar market. While Humira has long stood as the top-selling drug globally, the expiration of its patent exclusivity opened the door for biosimilar competition. However, widespread adoption of biosimilars in the U.S. has been gradual, due in part to complexities around interchangeability, provider confidence, and pricing dynamics.
With a full interchangeability designation, YUFLYMA is now better positioned to compete not only on price and convenience, but also on the regulatory assurance that it meets the highest standards of clinical equivalence to Humira. This distinction may help accelerate uptake among prescribers and pharmacies, thereby improving biosimilar adoption rates and helping reduce national spending on biologic therapies.
Looking ahead, Celltrion’s successful U.S. market strategy for YUFLYMA may serve as a model for other biosimilar developers seeking to gain a foothold in competitive therapeutic areas. By combining clinical rigor, regulatory strategy, and patient-centered pricing, the company has demonstrated how biosimilars can thrive in even the most entrenched drug categories.
The FDA’s expanded interchangeability designation for YUFLYMA marks a watershed moment for Celltrion and the U.S. biosimilars market. By achieving full regulatory parity with Humira across all approved forms and strengths, YUFLYMA now stands as a compelling alternative for patients and providers alike. Coupled with a strategic price reduction and flexible branding, Celltrion has positioned YUFLYMA to drive increased access to life-changing therapies for inflammatory and autoimmune diseases—ushering in a new era of value-based biologic treatment in the U.S.
As the biosimilar field continues to mature, Celltrion’s achievement underscores the power of innovation, clinical evidence, and patient-focused strategy in transforming healthcare affordability and accessibility.
