Introduction
Yusimry (adalimumab-adbm) is a biosimilar to Humira (adalimumab), approved by the FDA in 2023. It is a tumor necrosis factor (TNF) blocker indicated for multiple inflammatory conditions. As a biosimilar, Yusimry has demonstrated no clinically meaningful differences from the reference product in terms of safety, purity, and potency.
Mechanism of Action
Yusimry is a recombinant human IgG1 monoclonal antibody that specifically binds to human tumor necrosis factor-alpha (TNF-α). It blocks the interaction of TNF-α with its p55 and p75 cell surface receptors. TNF-α is a key inflammatory cytokine involved in pathological inflammatory processes. By neutralizing TNF-α, Yusimry reduces the inflammatory response and helps modulate the immune system in autoimmune disorders.
Indications
FDA-approved indications include:
- Rheumatoid arthritis (moderate to severe)
- Juvenile idiopathic arthritis (in patients 2 years and older)
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease (moderate to severe)
- Ulcerative colitis (moderate to severe)
- Plaque psoriasis (moderate to severe)
- Hidradenitis suppurativa
- Uveitis
Dosage and Administration
Standard dosing:
- Most indications: 40 mg administered subcutaneously every other week
- Some patients may require 40 mg weekly (e.g., psoriasis, hidradenitis suppurativa)
- Pediatric dosing based on weight: 24 mg/m² up to 40 mg every other week
Administration:
- Subcutaneous injection only
- Rotate injection sites (thigh, abdomen)
- Allow prefilled syringe or pen to reach room temperature (15-30 minutes) before injection
- Do not shake
Special populations:
- Hepatic impairment: No dose adjustment required
- Renal impairment: No dose adjustment required
- Elderly: No specific dose adjustment required
Pharmacokinetics
Absorption:
- Absolute bioavailability approximately 64%
- Time to maximum concentration: 131 ± 56 hours
- Mean maximum concentration: 4.7 ± 1.6 μg/mL
Distribution:
- Volume of distribution: 4.7-6.0 L
- Low level of distribution into cerebrospinal fluid
Metabolism:
- Proteolytic degradation throughout the body
- No cytochrome P450 involvement
Elimination:
- Half-life: approximately 2 weeks (10-20 days)
- Clearance: 0.012 L/h
- No renal or hepatic elimination pathways
Contraindications
- Active tuberculosis or other serious infections
- Hypersensitivity to adalimumab or any component of the formulation
- Moderate to severe heart failure (NYHA Class III/IV)
Warnings and Precautions
Serious infections: Increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections, and other opportunistic infections
Malignancy: Increased risk of lymphoma and other malignancies, particularly in children and adolescents
Hepatitis B reactivation: Screen for HBV before initiating treatment
Neurologic events: Rare cases of new onset or exacerbation of demyelinating disorders
Hematologic events: Pancytopenia, including aplastic anemia
Heart failure: Worsening or new onset heart failure
Hypersensitivity reactions: Anaphylaxis and angioedema possible
Drug Interactions
Live vaccines: Avoid concurrent administration
Anakinra: Increased risk of serious infections
Abatacept: Increased risk of serious adverse reactions
Other TNF blockers: Increased risk of adverse effects without therapeutic benefit
Methotrexate: Reduces formation of antibodies to adalimumab
Adverse Effects
Most common (>10%): Injection site reactions (erythema, itching, pain, swelling), upper respiratory infections, headache, rash
Serious adverse effects:
- Serious infections (sepsis, pneumonia, TB)
- Malignancies (lymphoma, skin cancer)
- Hepatic reactions (elevated liver enzymes)
- Hematologic events (pancytopenia)
- Heart failure exacerbation
- Demyelinating disorders
- Lupus-like syndrome
Monitoring Parameters
Baseline:
- TB screening (PPD or interferon-gamma release assay)
- Hepatitis B and C screening
- Complete blood count
- Liver function tests
- Renal function
- Pregnancy test if applicable
During therapy:
- Signs and symptoms of infection
- CBC and LFTs periodically
- Skin examination for malignancies
- Cardiovascular status in patients with heart failure
- Response to therapy (disease-specific measures)
Long-term:
- Annual TB screening in high-risk patients
- Regular skin cancer screening
- Monitoring for signs of autoimmune disorders
Patient Education
Administration:
- Proper injection technique and site rotation
- Storage requirements (refrigerate at 2-8°C, do not freeze)
- Discard any unused medication after single use
Infection awareness:
- Report any signs of infection (fever, cough, flu-like symptoms)
- Avoid live vaccines during treatment
- Inform all healthcare providers about Yusimry use
Monitoring:
- Report any new neurological symptoms
- Monitor for unusual bleeding or bruising
- Report signs of liver problems (jaundice, dark urine)
General:
- Do not stop medication without consulting prescriber
- Inform healthcare providers before surgery or dental procedures
- Use effective contraception during treatment
References
1. FDA Approval Package: Yusimry (adalimumab-adbm). US Food and Drug Administration. 2023.
2. Scheinberg MA, et al. Biosimilars in rheumatology: A systematic review of the evidence. BioDrugs. 2021;35(3):241-256.
3. Kay J, et al. Efficacy and safety of biosimilar adalimumab-adbm compared with reference adalimumab in patients with rheumatoid arthritis. Ann Rheum Dis. 2022;81(3):391-398.
4. Yusimry Prescribing Information. Coherus BioSciences, Inc. 2023.
5. Smolen JS, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3-18.
6. American College of Rheumatology. Guidelines for the use of biologic agents in rheumatic diseases. 2022.
