Hadlima Shortage: What Providers and Prescribers Need to Know in 2026

Updated:

March 12, 2026

Author:

Peter Daggett

Summarize this blog with AI:

A clinical briefing on Hadlima availability in 2026 for providers and prescribers. Covers supply status, formulary shifts, prescribing strategies, and tools.

Provider Briefing: Hadlima Availability in 2026

If your patients are reporting difficulty filling Hadlima (Adalimumab-bwwd) prescriptions, you're hearing a real and growing concern. While Hadlima is not currently listed on the FDA's drug shortage database, practical availability at the pharmacy level remains inconsistent across the country.

This article provides a clinical and logistical overview for physicians, nurse practitioners, physician assistants, and other prescribers who manage patients on Hadlima or are considering prescribing it. We'll cover the current supply landscape, formulary trends, prescribing implications, and resources to help you and your patients navigate access challenges.

Timeline: Hadlima's Entry Into the US Market

Understanding Hadlima's market history helps contextualize the current availability picture:

  • July 2019: FDA approves Hadlima (Adalimumab-bwwd) as a biosimilar to Humira
  • July 2023: Hadlima launches commercially in the US following patent litigation settlement with AbbVie
  • January 2023: Amjevita (Adalimumab-atto) becomes the first Adalimumab biosimilar available in the US
  • 2023-2024: Multiple additional biosimilars launch — Hyrimoz, Cyltezo, Yusimry, Abrilada, and others
  • 2025-2026: Insurance formularies increasingly prefer biosimilars; market share shifts accelerate

Hadlima entered a competitive market with roughly a dozen Adalimumab biosimilars approved or launching. This competition benefits patients through lower pricing but creates fragmentation in pharmacy stocking.

Prescribing Implications

For providers, the biosimilar landscape introduces several prescribing considerations:

Formulary Variability

Different payers prefer different biosimilars based on contract negotiations. A prescription for Hadlima may be covered under one patient's plan but not another's. Before prescribing, consider:

  • Checking the patient's formulary or asking them to verify with their insurance
  • Writing "adalimumab biosimilar — dispense as formulary allows" when clinically appropriate
  • Maintaining familiarity with 2-3 preferred biosimilars across major payers in your region

Prior Authorization Requirements

Virtually all payers require prior authorization for Adalimumab products, including biosimilars. Key considerations:

  • PA criteria are generally identical across Adalimumab biosimilars — step therapy through conventional DMARDs is standard
  • Some plans have streamlined PA for biosimilar-naive patients starting on a preferred biosimilar
  • Switching from Humira to a biosimilar may require a new PA but is often expedited

Biosimilar Switching

Clinical data supports the safety of switching between Adalimumab products. The NOR-SWITCH trial and subsequent studies have demonstrated no increase in adverse events, immunogenicity, or loss of efficacy when switching from the reference product to a biosimilar. For patients stable on Humira, switching to Hadlima or another biosimilar is clinically appropriate when driven by formulary or cost considerations.

Current Availability Picture

As of early 2026, Hadlima's availability varies significantly by distribution channel:

Specialty Pharmacies

This is the primary channel for Hadlima distribution. Major specialty pharmacies (Accredo, CVS Specialty, OptumRx, AllianceRx Walgreens) generally maintain adequate stock. Patients enrolled with a specialty pharmacy typically receive home delivery within 3-5 business days.

Retail Pharmacies

Retail pharmacy stocking of Hadlima remains inconsistent. Many chain pharmacies stock only their formulary-preferred biosimilar (which varies by pharmacy benefit manager). Independent pharmacies can special-order Hadlima but may not carry it routinely.

Hospital and Clinic Pharmacies

Institutional settings that administer biologics (e.g., infusion centers, though Adalimumab is subcutaneous) may stock Hadlima's institutional vial presentation (40 mg/0.8 mL single-dose vial). Availability depends on the institution's formulary decisions.

Cost and Access Considerations

Hadlima's pricing is among the most competitive in the Adalimumab biosimilar class:

  • WAC: approximately $1,038 per carton (single 40 mg dose) — roughly 85% below Humira's WAC of $6,922
  • Insured patients: Out-of-pocket costs depend on plan design (co-pay vs. coinsurance, specialty tier placement)
  • Organon $0 co-pay card: Available for eligible commercially insured patients
  • Patient assistance: Organon Assist program available for uninsured/underinsured patients

For a detailed breakdown of savings options to share with patients, see how to save money on Hadlima. For provider-specific cost guidance, see our provider's guide to helping patients save on Hadlima.

Tools and Resources for Providers

Several resources can help you and your care team address Hadlima access issues:

Medfinder for Providers

Medfinder allows providers to check real-time pharmacy availability for Hadlima and other medications. This can be incorporated into your prescribing workflow — before sending a prescription, verify that the destination pharmacy has stock.

Organon Provider Resources

Organon offers provider-facing materials including:

  • Prescribing information and medication guides
  • Patient enrollment forms for the $0 co-pay program
  • Contact information for Organon's medical affairs team

Electronic Prescribing Tips

When e-prescribing Hadlima, ensure you:

  • Select the correct NDC — Hadlima has multiple presentations (0.8 mL and 0.4 mL, syringe and autoinjector)
  • Specify the patient's preferred delivery device (prefilled syringe vs. PushTouch autoinjector)
  • Send the prescription to the patient's specialty pharmacy if required by their plan

Peer Resources

For clinical questions about Adalimumab biosimilars, the following may be helpful:

  • ACR (American College of Rheumatology) biosimilar position statements
  • AGA (American Gastroenterological Association) biosimilar guidance
  • AAD (American Academy of Dermatology) biosimilar resources

Looking Ahead

The Adalimumab biosimilar market is expected to continue maturing through 2026 and beyond. Key trends to watch:

  • Formulary consolidation: Payers may narrow preferred biosimilar lists, which could improve availability for preferred products but create access issues for non-preferred ones
  • Interchangeability expansion: As more biosimilars gain interchangeable status (Cyltezo already has it), pharmacy-level substitution may become more common
  • Price competition: Continued downward pressure on WAC pricing benefits patients and the healthcare system
  • Patient familiarity: As more patients use biosimilars successfully, adoption resistance decreases

For patient-facing information you can share, see our patient shortage update. For hands-on guidance about helping patients find this medication, read our provider's guide to helping patients find Hadlima.

Final Thoughts

Hadlima is a safe, effective, and significantly more affordable alternative to Humira. The primary barrier for patients is not clinical — it's logistical. As prescribers, we can help by:

  • Understanding which biosimilars are preferred on our patients' formularies
  • Proactively directing prescriptions to specialty pharmacies when required
  • Educating patients about biosimilar safety and equivalence
  • Utilizing tools like Medfinder to verify availability before prescribing
  • Connecting patients with manufacturer savings programs and patient assistance

The biosimilar transition represents one of the most significant cost-reduction opportunities in specialty pharmacy. By staying informed and proactive, providers can ensure their patients benefit from it.

Is it safe to switch patients from Humira to Hadlima?

Yes. Clinical studies, including the NOR-SWITCH trial, have demonstrated that switching from reference Adalimumab to biosimilars does not increase the risk of adverse events, immunogenicity, or loss of efficacy. Hadlima has been shown to be highly similar to Humira with no clinically meaningful differences.

Does Hadlima require a separate prior authorization from other Adalimumab biosimilars?

Yes, each Adalimumab product requires its own prior authorization, though the clinical criteria are generally the same across products. Some payers have streamlined the PA process for their preferred biosimilar, so switching to the formulary-preferred product may result in faster approval.

What dosage forms does Hadlima come in?

Hadlima is available as a 40 mg/0.8 mL and 40 mg/0.4 mL (citrate-free) in both prefilled glass syringes and the Hadlima PushTouch autoinjector. There is also a 40 mg/0.8 mL single-dose glass vial for institutional use only. Dosing follows the same schedule as Humira for all approved indications.

How can I help patients who can't find Hadlima at their pharmacy?

Direct them to their insurance company's preferred specialty pharmacy, which is the primary distribution channel for biologics. You can also use Medfinder at medfinder.com/providers to check pharmacy stock, connect patients with Organon's patient support program, or consider prescribing an alternative biosimilar that may be more readily available on the patient's formulary.

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