Dalibra (adalimumab biosimilar) / Biocad - LARVOL DELTA

A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects (clinicaltrials.gov) - P1 | N=444 | Completed | Sponsor: Biocad | Recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ Feb 2026 | Trial primary completion date: Nov 2025 ➔ Feb 2026

Trial completion • Trial completion date • Trial primary completion date

A Double-Blind, Comparative, Randomized Clinical Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL After a Single Subcutaneous Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=413 | Recruiting | Sponsor: Biocad

New P1 trial

Long-term data on the proposed adalimumab biosimilar BCD-057 in patients with moderate to severe psoriasis: A randomized controlled trial. (PubMed, PLoS One) - P3 | "Obtained data demonstrate that BCD-057 and iADA are highly similar in clinical efficacy, pharmacokinetics, safety, and immunogenicity in patients with moderate to severe plaque psoriasis."

Journal • Dermatology • Immunology • Psoriasis

CALYPSO: Comparative Clinical Trial of Efficacy and Safety of BCD-057 and Humira® in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3; N=344; Completed; Sponsor: Biocad; Active, not recruiting ➔ Completed

Clinical • Trial completion • Dermatology • Immunology • Psoriasis

[VIRTUAL] Health-Economic Analysis of Tocilizumab in Patients with Rheumatoid Arthritis and Systemic Juvenile Arthritis (ISPOR-EU 2020) - "RESULTS Cost minimizing ratio of tocilizumab (subcutaneous form) in RA patients comparing to adalimumab (Humira), сertolizumab pegol, golimumab were 111536 RUR; 129094 RUR; 85244 RUR, consequently favor to tocilizumab. Tocilizumab was less costly comparing to adalimumab (Humira), certolizumab pegol, golimumab by 12.8%, 14.5%, 10,0%, consequently...Tocilizumab was more costly comparing to adalimumab (Dalibra) etanercept, infliximab (Remicade) by 5.6%, 7.7%, 3.9 %, consequently...The share of bDMARDs in total costs structure was 84%-96%. CONCLUSIONS Tocilizumab is economically reasonable comparing to others TNF-α inhibitors in patients with RA and sJA."

Clinical • HEOR • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • Tuberculosis

The adalimumab biosimilar BCD-057 vs. innovator adalimumab in patients with moderate-to-severe plaque psoriasis: 55-week results from Phase 3/CALYPSO study (EADV 2019) - No abstract available.

Clinical • P3 data

Biocad plans to launch biosimilar of Humira in Russia (The Pharma Letter) - "Russian‘s leading drugmaker Biocad has registered a biosimilar of Humira (adalimumab), the world’s best-selling drug, used for the treatment of rheumatoid arthritis and psoriasis, among other inflammatory conditions, according to the company....The new biosimilar registered by Biocad is known as Dalibra....Dalibra to be priced at around 30% lower than Humira. Biocad expects the new biosimilar, which has been under development by the company since 2013, will enter the market as early as 2019."

Biosimilar launch • Non-US regulatory • Pricing