The US pharmaceutical landscape witnessed a significant shift as four new biosimilars to AbbVie's blockbuster drug Humira (adalimumab) entered the market in July, promising substantial cost savings for patients. This marks a pivotal moment for the healthcare industry, as Humira stands as the highest-grossing pharmaceutical product in history, with over $200 billion in global sales since its 2002 approval.
Market Entry and Pricing Strategy
Organon and Samsung Bioepis led the wave of launches on July 1st with their biosimilar Hadlima (adalimumab-bwwd), priced at $1,038 per carton containing two pre-filled pens or syringes - representing an 85% reduction from Humira's list price. The original Humira typically costs between $7,299 to $14,588 for two subcutaneous kits, depending on dosage.
Sandoz followed with Hyrimoz (adalimumab-adaz), featuring a citrate-free high concentration formulation that reduces injection volume by half. The company is supporting patient access through its Sandoz One Source program, which provides educational resources and reimbursement assistance.
Innovation in Biosimilar Development
Boehringer Ingelheim achieved a notable milestone with Cyltezo (adaliumam-adbm), securing status as the first and only FDA-approved interchangeable biosimilar to Humira. "This interchangeability designation allows pharmacists to substitute Cyltezo for Humira without requiring a new prescription, while maintaining safety and efficacy," explains Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim.
Celltrion rounded out the launches on July 3rd with Yuflyma (adalimumab-aaty), offering both auto-injector and pre-filled syringe options at a monthly list price of $6,576.50.
Therapeutic Applications and Market Impact
All four biosimilars are approved for treating multiple conditions where Humira's exclusivity has expired, including:
- Rheumatoid arthritis
- Crohn's disease
- Plaque psoriasis
- Ulcerative colitis
- Hidradenitis suppurativa
The impact of biosimilar competition is already evident in AbbVie's financial performance, with Humira's international sales declining 22% in late 2022 and further dropping 25% in the first quarter of 2023. This trend aligns with findings from the Leonard D Shaeffer Center for Health Policy & Economics at USC, which confirms that biosimilar entry promotes market competition and price reduction.
