Adalimumab (adalimumab)

Adalimumab is a biologic: there is no AB-rated generic, no ANDA and no interchangeable 'generic' in the small-molecule sense. Follow-on products are biosimilars licensed under FDA 351(k) or the EMA biosimilar pathway and must demonstrate analytical, non-clinical and clinical similarity to the reference product; they are not pharmacy-substitutable for Humira unless the regulator grants interchangeability. Several adalimumab biosimilars (e.g. adalimumab-adbm/Cyltezo) hold FDA interchangeability status. Zydus Cadila's Exemptia is an Indian 'similar biologic' approved by the DCGI, not an FDA/EMA biosimilar, so it cannot be treated as a generic substitute. Manufacturers supplying adalimumab generic versions include Biocon Biologics, Celltrion, Cipla, Glenmark, Hetero Drugs, Mabwell / Junshi Biosciences, Sandoz, Torrent Pharmaceuticals. Brands registered in Bangladesh include Adali, Adalimab, Adimab, Advixa, Hyrimoz, Yuflyma.

Adalimumab (TNF blocker — recombinant fully human IgG1 monoclonal antibody against TNF-alpha (biologic DMARD / bDMARD), originally Humira (修美乐) by AbbVie (originally developed and marketed by Abbott Laboratories; initial U.S. approval 2002)) Adalimumab is a lab-made antibody that binds to TNF-alpha, a chemical messenger that drives inflammation. By blocking TNF-alpha it reduces joint swelling and pain and calms inflammation in the gut, skin and eyes. Adults (RA, PsA, AS): 40 mg subcutaneous every other week. Some RA patients not receiving methotrexate may increase to 40 mg every week or 80 mg every other week. Plaque psoriasis and adult uveitis: 80 mg initial dose, then 40 mg every other week starting one week later. Crohn's disease: 160 mg on Day 1, 80 mg on Day 15, then 40 mg every other week from Day 29. Ulcerative colitis: same 160/80/40 m

Bangladesh unit prices for adalimumab are not published per unit; the registry lists pack prices only. Prices move with pack size, pharmacy and the exchange rate — confirm current stock and price with a licensed importer before ordering.

Standard dosing for adalimumab: Adults (RA, PsA, AS): 40 mg subcutaneous every other week. Some RA patients not receiving methotrexate may increase to 40 mg every week or 80 mg every other week. Plaque psoriasis and adult uveitis: 80 mg initial dose, then 40 mg every other week starting one week later. Crohn's disease: 160 mg on Day 1, 80 mg on Day 15, then 40 mg every other week from Day 29. Ulcerative colitis: same 160/80/40 mg regimen; discontinue if no clinical remission by week 8 (Day 57). Hidradenitis suppurativa: 160 mg Day 1, 80 mg Day 15, then 40 mg every week or 80 mg every other week from Day 29. Dose adjustments: Pediatric dosing is weight-based (10 kg to <15 kg: 10 mg every other week; 15 kg to <30 kg: 20 mg every other week; 30 kg and greater: 40 mg every other week for JIA/pediatric uveitis). The FDA label states that no pharmacokinetic data are available in patients with hepatic or renal impairment, and no renal- or hepatic-impairment dose adjustment is specified in the label.

Adalimumab is a biologic: there is no AB-rated generic, no ANDA and no interchangeable 'generic' in the small-molecule sense. Follow-on products are biosimilars licensed under FDA 351(k) or the EMA biosimilar pathway and must demonstrate analytical, non-clinical and clinical similarity to the reference product; they are not pharmacy-substitutable for Humira unless the regulator grants interchangeability. Several adalimumab biosimilars (e.g. adalimumab-adbm/Cyltezo) hold FDA interchangeability status. Zydus Cadila's Exemptia is an Indian 'similar biologic' approved by the DCGI, not an FDA/EMA biosimilar, so it cannot be treated as a generic substitute. Manufacturers supplying adalimumab generic versions include Biocon Biologics, Celltrion, Cipla, Glenmark, Hetero Drugs, Mabwell / Junshi Biosciences, Sandoz, Torrent Pharmaceuticals. Brands registered in Bangladesh include Adali, Adalimab, Adimab, Advixa, Hyrimoz, Yuflyma.

Adalimumab (TNF blocker — recombinant fully human IgG1 monoclonal antibody against TNF-alpha (biologic DMARD / bDMARD), originally Humira (修美乐) by AbbVie (originally developed and marketed by Abbott Laboratories; initial U.S. approval 2002)) Adalimumab is a lab-made antibody that binds to TNF-alpha, a chemical messenger that drives inflammation. By blocking TNF-alpha it reduces joint swelling and pain and calms inflammation in the gut, skin and eyes. Adults (RA, PsA, AS): 40 mg subcutaneous every other week. Some RA patients not receiving methotrexate may increase to 40 mg every week or 80 mg every other week. Plaque psoriasis and adult uveitis: 80 mg initial dose, then 40 mg every other week starting one week later. Crohn's disease: 160 mg on Day 1, 80 mg on Day 15, then 40 mg every other week from Day 29. Ulcerative colitis: same 160/80/40 m

Storage: Store in a refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton until use to protect from light. Do not freeze. If needed (for example when travelling), Humira may be stored at room temperature up to 77°F (25°C) for up to 14 days. Do not use if the liquid has flakes or particles, has been frozen, or is past expiry. Keep the product in its original packaging and check the expiry date printed on the pack.

Recommended monitoring for adalimumab: Test for latent TB before starting and during therapy; treat latent TB before starting; monitor for active TB throughout; Monitor closely for signs and symptoms of serious infection during and after treatment; Monitor for hepatitis B virus reactivation in HBV carriers; Monitor for new-onset or worsening heart failure and discontinue if it occurs; Monitor for neurologic symptoms suggestive of demyelinating disease; Monitor blood counts for cytopenias and monitor for hypersensitivity/injection reactions; Monitor for malignancy during and after treatment

Standard dosing for adalimumab: Adults (RA, PsA, AS): 40 mg subcutaneous every other week. Some RA patients not receiving methotrexate may increase to 40 mg every week or 80 mg every other week. Plaque psoriasis and adult uveitis: 80 mg initial dose, then 40 mg every other week starting one week later. Crohn's disease: 160 mg on Day 1, 80 mg on Day 15, then 40 mg every other week from Day 29. Ulcerative colitis: same 160/80/40 mg regimen; discontinue if no clinical remission by week 8 (Day 57). Hidradenitis suppurativa: 160 mg Day 1, 80 mg Day 15, then 40 mg every week or 80 mg every other week from Day 29. Dose adjustments: Pediatric dosing is weight-based (10 kg to <15 kg: 10 mg every other week; 15 kg to <30 kg: 20 mg every other week; 30 kg and greater: 40 mg every other week for JIA/pediatric uveitis). The FDA label states that no pharmacokinetic data are available in patients with hepatic or renal impairment, and no renal- or hepatic-impairment dose adjustment is specified in the label.

Adalimumab is approved for: Rheumatoid arthritis: moderately to severely active RA in adults — reduces signs/symptoms, induces major clinical response, inhibits progression of structural damage, improves physical function; Polyarticular juvenile idiopathic arthritis: moderately to severely active pJIA in patients 2 years of age and older; Psoriatic arthritis: active PsA in adults — reduces signs/symptoms, inhibits structural damage progression, improves physical function; Ankylosing spondylitis: active AS in adults — reduces signs and symptoms; Crohn's disease: moderately to severely active CD in adults and pediatric patients 6 years and older. It is a adalimumab (TNF blocker — recombinant fully human IgG1 monoclonal antibody against TNF-alpha), originally marketed as Humira (修美乐) by AbbVie (originally developed and marketed by Abbott Laboratories; initial U.S. approval 2002).