Hadlima (adalimumab-bwwd) — FDA-Approved Biosimilar to Humira (adalimumab)

TNF-alpha Inhibitor Biosimilar · Approved 2019 · $0–$35/mo for most insured patients

🔬 What Is Hadlima?

Hadlima (adalimumab-bwwd) is an FDA-approved biosimilar to Humira (adalimumab). A biosimilar is a biological medication that is highly similar to an already-approved reference biologic, with no clinically meaningful differences in safety, purity, or potency. Hadlima (adalimumab-bwwd) is an FDA-approved Humira biosimilar from Samsung Bioepis and Organon, available in a high-concentration citrate-free formulation. It offers the same therapeutic benefits as Humira for all approved indications at potentially lower cost.

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With Insurance

$0–$35/mo for most insured patients

Organon Patient Support

Uninsured / PAP

Free

Income-based assistance

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Hadlima Overview

Property	Details
Brand Name	Hadlima
Generic Name	adalimumab-bwwd
Reference Biologic	Humira (adalimumab)
Manufacturer	Samsung Bioepis/Organon
Drug Class	TNF-alpha Inhibitor Biosimilar
FDA Approval	2019
Route	Subcutaneous injection
Approved Conditions	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease, Ulcerative Colitis, JIA
Copay Program	Organon Patient Support — $0–$35/mo for most insured patients

Approved Conditions

✓Rheumatoid Arthritis✓Psoriatic Arthritis✓Ankylosing Spondylitis✓Plaque Psoriasis✓Crohn's Disease✓Ulcerative Colitis✓JIA

Hadlima vs Humira (adalimumab)

Hadlima has been demonstrated to be biosimilar to Humira (adalimumab) through comprehensive analytical, non-clinical, and clinical studies. The FDA requires that biosimilars have no clinically meaningful differences from the reference product. Patients who are stable on Humira (adalimumab) should discuss any potential switch to Hadlima with their prescriber.

Factor	Hadlima	Humira (adalimumab)
FDA Status	Biosimilar (approved 2019)	Reference biologic
Active Ingredient	adalimumab-bwwd	adalimumab
Mechanism	TNF-alpha Inhibitor	Same
Approved Indications	Same as Humira (adalimumab)	Multiple FDA-approved
Typical Patient Cost	$0–$35/mo for most insured patients	$0–$35/mo (varies by plan)

Yes. The FDA requires biosimilars to demonstrate there are no clinically meaningful differences in safety, purity, and potency compared to the reference product. Hadlima underwent rigorous clinical studies demonstrating biosimilarity to Humira (adalimumab). Your prescriber can discuss whether Hadlima is appropriate for your specific situation.

Many patients do switch from reference biologics to biosimilars. The decision should be made in consultation with your prescriber. Switching is generally safe for stable patients, but your doctor may want to monitor you during the transition. BiologicHealthPlus can coordinate the prior authorization for Hadlima and ensure a seamless supply transition.

Most commercial insurance plans and Medicare Part D cover Hadlima with prior authorization. In many cases, Hadlima may have a lower tier placement on formularies than Humira (adalimumab), potentially reducing your copay. BiologicHealthPlus verifies your insurance coverage, handles all prior authorization, and enrolls you in the Organon Patient Support copay program to minimize your out-of-pocket costs.

Without insurance, Hadlima costs approximately $1150/month at list price — lower than Humira (adalimumab)'s list price. Uninsured or underinsured patients may qualify for patient assistance through Organon Patient Support. BiologicHealthPlus will find every available savings option for you at no charge.

📚 Sources & Further Reading

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FDA Biosimilar ApprovalsFDA

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BiosimilarWikipedia

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ACR Biosimilar PositionACR

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Biosimilar DevelopmentNIH/NCBI

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Medicare Biosimilar CoverageCMS

Medical Disclaimer: Educational content reviewed by BiologicHealthPlus Clinical Team. Last reviewed: August 2026.

Medical Disclaimer: This page is for informational purposes only. Hadlima requires a valid prescription. Consult your physician before making any changes to your medication. Last updated: August 2026.