Celltrion Healthcare is seeking interchangeability designation for its adalimumab biosimilar, Yuflyma, while Formycon reports positive Phase 3 results for its ustekinumab biosimilar, FYB202. These developments occur as the market anticipates increased biosimilar competition for Humira (adalimumab) and Stelara (ustekinumab) in the coming years.
Celltrion's Interchangeability Study for Yuflyma
Celltrion Healthcare has initiated the process to secure interchangeability status for Yuflyma, its biosimilar to Humira. The company has filed an investigational new drug application with the FDA for an international Phase 3 clinical trial. This trial aims to demonstrate that Yuflyma can be substituted for Humira without any reduction in efficacy or increase in safety risks.
The Phase 3 study will enroll 366 patients with plaque psoriasis. Participants will be administered either Humira or Yuflyma, with some patients being switched between the two products. The study will assess pharmacokinetics, efficacy, and safety after these switches to confirm Yuflyma's interchangeability. Yuflyma is already approved in the European Union as the first high-concentration adalimumab biosimilar.
Currently, seven adalimumab biosimilars have been FDA-approved, with Yuflyma potentially launching in July 2023 alongside at least five others. Boehringer Ingelheim's Cyltezo is the only adalimumab biosimilar with an interchangeability designation, making Celltrion's pursuit a significant competitive move.
Formycon's Ustekinumab Biosimilar Shows Promise
Formycon, based in Munich, Germany, has announced positive safety and efficacy data from a Phase 3 trial of its ustekinumab biosimilar, FYB202, compared to Stelara. The study focused on patients with moderate to severe psoriasis vulgaris, the most common type of psoriasis, accounting for 80% to 90% of cases.
The multicenter, randomized, double-blinded study demonstrated that FYB202 is comparable to Stelara. The biosimilar met the primary endpoint, showing a similar percent improvement in the Psoriasis Area and Severity Index (PASI) after 12 weeks of treatment. Furthermore, the trial found no clinically meaningful differences in adverse events or immunogenicity between FYB202 and Stelara.
Ustekinumab, the target of both Stelara and FYB202, is a human monoclonal antibody that targets interleukin (IL)-12 and IL-23, cytokines involved in inflammatory processes. Stelara is indicated for various inflammatory conditions, including psoriasis and psoriatic arthritis.
"With FYB202 we have a promising biosimilar candidate and are addressing an important and growing market in the inflammatory diseases segment. The positive interim phase III study results mark an important milestone and underline our expertise in the development of high-quality biosimilars," said Stefan Glombitza, PhD, CEO of Formycon.
