Studies comparing several investigational biosimilar candidates to Humira (adalimumab) were presented at the American College of Rheumatology’s annual meeting this week and found clinical similarities to the widely-used biologic.
Findings from studies for biosimilar candidates from Amgen, ABP 501, and Boehringer Ingelheim (BI), BI695501, showed that both are similar to adalimumab in either make-up or effectiveness and regarding safety and tolerability profiles.
A phase 3 study comparing its biosimilar candidate ABP 501 to adalimumab in patients with moderate-to-severe rheumatoid arthritis (RA) found that ABP 501 demonstrated clinical equivalence with adalimumab:
- Almost 75 percent of patients treated with APB 501 achieved a 20 percent improvement in RA symptoms compared to 72.4 percent of patients treated with adalimumab.
- 49.2 percent of patients in the APB 501 treatment group achieved a 50 percent improvement in RA symptoms compared to 52 percent in the adalimumab group.
- 26 percent of patients treated with ABP 501 achieved a 70 percent improvement in RA symptoms compared to 22.9 percent in the adalimumab group.
The findings also showed treatment-related adverse events, including common cold, headaches, joint pain, cough and upper respiratory infection, were reported at similar levels for both treatments.
According to a company press release, overall, Amgen has nine biosimilars in development and plans to launch these treatments still under investigation currently starting in 2017.
In an earlier stage (Phase 1) study presented at the ACR meeting, BI’s biosimilar BI695501demonostrated pharmacokinetic bioequivalence with both the U.S. and EU-approved versions of adalimumab, which signifies similarity in the way the treatments are absorbed, metabolized and excreted from the body. The study abstract noted there were no noticeable differences in safety between BI695501 and adalimumab.
BI issued a press release yesterday announcing enrollment for a Phase 3 study of this investigational biosimilar is now completed. The randomized, double-blind, parallel arm, multiple dose study will include patients who have been diagnosed with moderate-to-severe RA and are currently being treated with methotrexate. Each participant is randomized to receive either BI695501 or the U.S.-licensed reference product every two weeks for 48 weeks.