DailyMed
Cure8 regulatory brief
DailyMed label update for HADLIMA
Medications
Adalimumab
Anti-TNF
Biosimilars
Regulatory Update
Adult patients
Pediatric Patients
Clinicians
Why This Matters
This is an official drug‑label update for HADLIMA (adalimumab‑bwwd), a biosimilar to HUMIRA, which lists Crohn’s disease and ulcerative colitis among approved uses and includes important safety warnings relevant to people with IBD.
Who Should Pay Attention
Adults and pediatric patients with Crohn’s disease or ulcerative colitis, caregivers, and clinicians who prescribe or monitor anti‑TNF therapy.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Source depthMetadata only
What To Know
This DailyMed entry is an updated official drug label (HADLIMA, adalimumab‑bwwd), a biosimilar to HUMIRA.
The label lists FDA‑approved indications including Crohn’s disease and ulcerative colitis, dosing for adults and pediatric patients, boxed warnings about serious infections and malignancy (including hepatosplenic T‑cell lymphoma in young IBD patients), and standard precautions such as testing for latent tuberculosis prior to starting therapy.
The label provides induction and maintenance dosing schedules for Crohn’s disease and ulcerative colitis, pediatric weight‑based dosing for children 6 years and older with Crohn’s disease, and administration details for subcutaneous injection. It also notes dosage forms and recent updates to warnings and precautions.
If you are using or considering adalimumab/HADLIMA, consult your clinician and refer to the full prescribing information for complete safety, contraindications, and monitoring guidance. This note summarizes the updated label content provided on DailyMed and does not replace medical advice or the full label text.
Keep In Mind
This is the manufacturer’s updated prescribing information hosted on DailyMed (regulatory drug‑label record). It summarizes approved indications, dosing, and safety warnings; interpret with clinician guidance. The label includes boxed warnings and monitoring recommendations (e.g., latent TB testing).
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Evidence type derived from source or registry metadata.
PublicationDailyMed
Study typeDrug Label Update
Indexed viaDailyMed
Source typeDrug label record
PublishedOct 30, 2026, 12:00 AM
Content availableMetadata only
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
DailyMed label update for AMJEVITA
An updated drug label for AMJEVITA affects people with Crohn's disease, ulcerative colitis, and other immune conditions because it defines FDA‑approved uses, dosing schedules (including pediatric dosing), and safety...
Injection Site Pain and Adherence in Patients Switching from Reference Adalimumab to AVT02 - Ease Pain Trial (Full Analysis)
Injection site pain and local reactions can affect comfort and willingness to continue injectable biologic therapy.
DailyMed label update for ADALIMUMAB
This is an official prescribing-label update for an adalimumab biosimilar used to treat Crohn’s disease and ulcerative colitis, including pediatric indications and dosing. Changes to indications or pediatric dosing and...