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Alvotech's Ustekinumab Candidate Reaches Clinical Trial Milestone
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.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Health Canada Approves First Omalizumab Biosimilar
December 16th 2024Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
