The sword refers to the successful phase III clinical trial of Johnson & Johnson's Stelara Amgen biosimilar drug ABP 654!

Recently, Amgen announced the preliminary results of a Phase 3 clinical study
.
This is a multicenter, randomized, double-blind, comparative clinical study (Study ID: 04607980) evaluating the biosimilar ABP 654 versus Stelara (hi Dano, ustekinumab, ustekinumab) efficacy and safety
.
A total of 563 patients were enrolled in the study, including 281 in the ABP 654 treatment group and 282 in the Stelara treatment group
.
Results showed that the study met its primary efficacy endpoint: no clinically meaningful difference between ABP 654 and Stelara
.
This preliminary assessment analyzed percent improvement in the Psoriasis Area and Severity Index (PASI) from baseline to Week 12 of treatment
.
The data showed a mean difference in percent improvement in PASI between ABP 654 and Stelara of 0.
14, which was within a pre-specified cut-off value
.
ABP 654 is comparable in security to Stelara
.
ABP 654 is currently being developed as a biosimilar to Stelara, which is identical to Stelara in dosage form, dose strength, route of administration and dosing schedule
.
Stelara is an old-fashioned anti-inflammatory drug from Johnson & Johnson, which is the world's first biological agent that can selectively target IL-12 and IL-23 at the same time
.
IL-12 and IL-23 are two naturally occurring cytokines with key roles in immune-mediated inflammatory diseases, including plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative Colitis,
etc.
Stelara specifically binds to the p40 subunit shared by IL-12 and IL-23 with high affinity, preventing its binding to cell surface receptors, thereby disrupting IL-12 and IL-23-mediated signaling and cytokine effects
.
It is understood that Stelara was launched in 2009 and has been approved for multiple indications, including: (1) Adult and pediatric patients with moderate to severe plaque psoriasis (≥6 years old) suitable for phototherapy or systemic therapy; ( 2) for the treatment of adults with active psoriatic arthritis; (3) for the treatment of adults with moderately to severely active Crohn's disease; (4) for the treatment of adults with moderately to severely active ulcerative colitis
.
It is worth noting that Stelara plays a mainstay role in Johnson & Johnson's pharmaceutical business segment
.
According to the company's financial report, Stelara's global sales in 2021 will reach US$9.
134 billion, an increase of 18.
5% over the previous year, accounting for 28% of its entire pharmaceutical business segment
.
However, Stelara's main U.
S.
patent will expire in 2023, and several companies are currently developing related biosimilars
.