Biocon Biologics (BBL) presented positive results from two Phase-III clinical studies at the European Academy of Dermatology and Venereology (EADV) Congress 2024. The studies focused on Biocon’s biosimilar versions of adalimumab and ustekinumab, used to treat chronic plaque psoriasis.
Two Phase-III studies have demonstrated that patients can safely switch between adalimumab, a well-known biologic therapy, and its biosimilar, adalimumab-fkjp, without compromising treatment outcomes. Additionally, the studies affirm the biosimilarity of Bmab 1200 to ustekinumab, another standard treatment for moderate to severe psoriasis.
This suggests that the potential for interchangeability is significant. If approved, it could lead to greater patient access to effective treatments and lower healthcare costs, benefiting both patients and healthcare systems alike. Doctors could now prescribe either medication with confidence, potentially offering greater treatment flexibility.
Speaking on this, Uwe Gudat, chief medical officer of Biocon Biologics, emphasised the implications of these findings. “Our data indicates that adalimumab-fkjp and reference adalimumab can be used interchangeably. This interchangeability could greatly enhance patient treatment flexibility and reduce costs without sacrificing efficacy or safety,” he stated.
The first study, which examined multiple switches between low-concentration adalimumab-fkjp and high-concentration adalimumab, found no significant differences in pharmacokinetics (PK), safety, or efficacy. At the 28-week mark, the Psoriasis Area and Severity Index (PASI) responses and static Physician’s Global Assessment (sPGA) success rates were nearly identical between patients who switched treatments and those who remained on the reference drug. These results meet the US Food and Drug Administration (FDA) requirements for a product to be classified as “interchangeable.”
The second study focused on Bmab 1200 and compared its effects with those of ustekinumab. Over 384 patients were evaluated for 52 weeks, with the primary endpoint showing equivalent efficacy between the two treatments. Gudat remarked, “This study fulfils the safety and efficacy expectations for a biosimilar, promising improved access to treatments for patients who qualify for ustekinumab.”
Biocon Biologics plans to submit the findings to the FDA for further review. Biocon is already a recognised player in the biosimilars market, with eight biosimilars commercialised across various regions.
As the conversation around biosimilars continues to evolve, these findings could reshape treatment protocols for chronic plaque psoriasis, offering new hope to patients and healthcare providers alike.
First Published: Sep 25 2024 | 5:41 PM IST
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