On 25 September 2024, Biocon Biologics Ltd announced new data on its adalimumab and ustekinumab biosimilars, presented at the 2024 European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam.
The first set of data is results from a Phase 3 study comparing the efficacy, safety, immunogenicity, and pharmacokinetics of Biocon’s Bmab 1200 (bUstekinumab), with Janssen’s Stelara® (ustekinumab) in adult patients with moderate to severe chronic plaque psoriasis. The results are said to show biosimilarity between Bmab 1200 and Stelara®.
In May 2024, Biocon announced that the FDA accepted its BLA for Bmab 1200 for review under the 351(k) pathway. In February 2024, Biocon entered a settlement agreement with Janssen enabling it to launch Bmab 1200 in the US in February 2025. A second patent settlement and licence agreement was entered between Biocon and Janssen in August 2024, allowing Biocon to commercialise Bmab 1200 in Europe, the UK, Canada and Japan. Biocon has submitted regulatory applications in each of these jurisdictions.
The second set of data is results from a Phase 3 study evaluating repeated switches between Biocon’s Hulio® (adalimumab-fkhp, 40mg/0.8ml) and AbbVie’s high-concentration Humira® (adalimumab, 40mg/0.4ml) in patients with moderate to severe chronic plaque psoriasis. This data reportedly shows interchangeability between the two products. Biocon says it has submitted the data to the FDA to support an interchangeable designation for its adalimumab biosimilar.
Biocon’s Hulio® (adalimumab-fkhp) was first approved in Europe in 2018 and in the US in 2020.