AVT04 (ustekinumab) if approved would be targeted at an estimated $7.7 billion market for the reference product, Stelara.
Reykjavik, Iceland-based company Alvotech said it has begun clinical evaluation of a potential ustekinumab biosimilar (AVT04), referencing Stelara, in patients with moderate-to-severe plaque psoriasis.
Recruitment has begun for a confirmatory efficacy and safety study (N = 530) in Central and Eastern Europe and a separate, pharmacokinetic (PK) comparability study (N = 294) in New Zealand and Australia. The latter study also will evaluate for safety and tolerability.
Alvotech noted in a statement that the ustekinumab market represents a lucrative opportunity. The reference product had global sales of $7.7 billion in 2020. Janssen Biotech discovered ustekinumab and holds exclusive US rights to distribution.
This marks the second Alvotech biosimilar candidate to enter clinical studies. The first was AVT02, an adalimumab candidate referencing a high-concentration form of Humira. Alvotech said a switching study is underway to support an interchangeable designation for AVT02 in the United States. The company said in June 2021 that it had reached the point where findings from the study could be reported to the FDA.
Biosimilars are approved as being equally safe and efficacious as originator drugs but the interchangeability designation would allow pharmacists to dispense the biosimilar in place of Humira without consulting the prescribing physician.
There are currently no interchangeable biosimilars approved in the United States, although at least 1 interchangeable insulin approval is anticipated in 2021. In Europe, where biosimilars are more widely used and accepted, pharmacists are sometimes directed to dispense biosimilars instead of originator products.
The FDA and the European Medicines Agency accepted regulatory approval applications for AVT02 in 2020. The company anticipates an FDA decision for AVT02 in September 2021 and an EMA decision in the fourth quarter of 2021.
For a recent interview with Alvotech's chief commercial officer about the prospects for AVT02, click here.