Biocon Biologics’ Phase 3 Trials Highlight Interchangeability and Biosimilarity in Psoriasis Treatments

On September 25, 2024, Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, shared new dermatology findings at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam. 

Data from two key Phase 3 clinical trials confirmed that adalimumab and adalimumab-fkjp can be used interchangeably. The studies also highlighted the biosimilarity of bUstekinumab.

Uwe Gudat, M.D., Chief Medical Officer, Biocon Biologics, said, “The extensive range of new data being presented at EADV this year underscores Biocon Biologics’ commitment to a high-science portfolio of biosimilar medicines that meet the clinical needs of physicians and patients while providing important sustainability benefits to health systems. These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity without variation of clinical outputs in patients with chronic plaque psoriasis.”

This study looked at the pharmacokinetics (how the drug moves in the body), effectiveness, safety, and immune response in patients with moderate to severe chronic plaque psoriasis. Patients were either given adalimumab continuously or switched between the reference adalimumab and its biosimilar, adalimumab-fkjp. 

The main goal was to assess if the lower-concentration adalimumab-fkjp (40 mg/0.8ml) and the higher-concentration reference adalimumab (40 mg/0.4ml) could be used interchangeably by comparing how the drug levels stayed steady in the body between the two groups.

After 28 weeks, the results showed that the number of patients with improvements in their Psoriasis Area and Severity Index (PASI) and success in the static Physicians Global Assessment (sPGA) were very similar between the two groups. The rate of side effects was also comparable, with 29.8% of patients in the switching group and 34.2% in the non-switching group experiencing adverse events.

The study confirmed that switching between low-concentration adalimumab-fkjp and high-concentration adalimumab produced similar drug concentration levels as continuous use of the high-concentration version. This supports the interchangeability of the two forms of adalimumab.

A total of 384 patients were observed over 52 weeks, with the main goal being to measure the percentage change in the Psoriasis Area and Severity Index (PASI) from the start of the study to Week 12. By Week 28, both Bmab 1200 and ustekinumab showed equivalent effectiveness, and the results confirmed that Bmab 1200 is biosimilar to ustekinumab.

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