Is the biosimilar BCD-055 as effective as infliximab?

This study investigated the safety and effectiveness of BCD-055 (BCD), a biosimilar of infliximab (IFX; Remicade).

They found that the safety and effectiveness of BCD were similar to IFX. 

Rheumatoid arthritis (RA) is a chronic condition. It is caused by painful inflammation in the joints. RA is treated with disease-modifying anti-rheumatic drugs (DMARDs). DMARDs can be synthetic or biological drugs (bDMARDs). bDMARDs usually work by blocking chemicals that cause inflammation. Infliximab (IFX) is a bDMARD that blocks tumor necrosis factor alpha (TNFα). 

IFX is an effective treatment for RA. It has been on the market for several years. Other companies have developed generic forms of IFX. Generic bDMARDs are called biosimilars. Biosimilars must be tested in patients to ensure they are just as safe and effective as the original drug. BCD-055 is a biosimilar of IFX. It is unclear if BCD-055is as safe and effective as IFX.

This study included 426 patients with RA. Patients were randomly assigned to either BCD or IFX. The dose of either BCD or IFX was 3 mg/kg via intravenous administration. The administration was on week 0, 2, 6 and every 8 weeks thereafter. RA symptoms were measured using the disease activity score 28 (DAS28). Side effects were also recorded during the study. 

At week 14 the disease response for BCD-treated patients was 71.2%. This compared to 67.9% in the IFX group. Disease response scores were similar at all other time points. The rates of side effects were similar in both groups (BCD: 74.64%; IFX: 66.67%). Antibody levels were similar in both groups (BCD: 28.46%; IFX: 26.56%).

The authors concluded that the safety and effectiveness of BCD were similar to IFX.

The patients in this study were not treated with bDMARDs before. It is unclear if BCD is as effective as IFX in patients previously treated with IFX.

If you have any concerns regarding biosimilars and RA please consult with your physician.