Celltrion Healthcare set its sights on obtaining an interchangeability designation for its adalimumab biosimilar, and Formycon released positive findings from a phase 3 trial involving its ustekinumab biosimilar.
As many companies prepare for Humira (adalimumab) and Stelara (ustekinumab) to face biosimilar competition in next few years, Celltrion is looking to have its adalimumab biosimilar stand out from the rest and Formycon is making progress to get a slice of the Stelara pie.
Celltrion Healthcare Begins Process for Interchangeability
According to a report by Pulse, Celltrion Healthcare filed an investigational new drug application with the FDA for an international phase 3 clinical trial that would establish the interchangeability of the company’s adalimumab biosimilar (Yuflyma) with Humira.
Yuflyma is 1 of 3 biosimilars that have biologics license applications under review with FDA and if approved, it is expected to launch in July 2023, along with at least 5 other adalimumab biosimilars. So far, there are 7 FDA-approved adalimumab biosimilars. Currently, only 1 company (Boehringer Ingelheim) has obtained an interchangeability designation for an adalimumab biosimilar (Cyltezo), and 5 others, including Celltrion, are also seeking the designation.
The phase 3 study will compare the treatment outcomes of 366 patients with plaque psoriasis, who are administered Humira vs Yuflyma, and patients will be switched back and forth between the products to verify the pharmacokinetics, efficacy, and safety of Yuflyma after switching.
Yuflyma was the first high-concentration adalimumab biosimilar in the world and was granted marketing authorization in the European Union.
Formycon Shares Phase 3 Data on Ustekinumab Biosimilar
Munich, Germany–based Formycon announced positive safety and efficacy data from a phase 3 trial comparing its ustekinumab biosimilar (FYB202) with Stelara in patients with moderate to severe psoriasis vulgaris, also known as plaque psoriasis.
Ustekinumab is a human monoclonal antibody that targets interleukin (IL)-12 and IL-23. Stelara is indicated to treat several inflammatory conditions, including psoriasis and psoriatic arthritis. Plaque psoriasis accounts for 80% to 90% of all psoriasis cases, making it the most common type of psoriasis.
The multicenter, randomized, double-blinded, comparative clinical study demonstrated that FYB202 was comparable with the reference product. The biosimilar met the primary end point of percent improvement of the Psoriasis Area and Severity Index after 12 weeks of therapy. Additionally, no clinically meaningful differences regarding adverse events and immunogenicity were observed.
“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, in a company statement.