Omalizumab is a versatile IgE inhibitor used to treat three indicated conditions: chronic urticaria (a systemic allergic reaction manifested by hives), rhinosinusitis with nasal polyps, and persistent and severe symptoms of allergic asthma.
According to the reference product manufacturer, Genentech (a subsidiary of Roche), Xolair’s 2022 US revenues were $2.5 billion, a 9% increase over 2021. Globally, sales are approximately $3.8 billion, with Novartis promoting the agent in the EU.
First approved in 2003, the main composition of matter patent has already expired, but the patent governing the formulation of this product, a subcutaneous injectable, will expire in November 2025 in the US. This suggests that the first omalizumab biosimilar will be available sometime in 2026 and be covered under the pharmacy benefit.
This product’s profile may sound enticing to biosimilar manufacturers, though relatively few have pressed along with their development programs. Here is a description of the publicly declared players so far.
It seems that biosimilar veteran Celltrion has a bit of a lead in the race to be first to file for approval. In June 2023, Celltrion successfully completed its phase 3 study of CT-P39 in more than 600 patients with chronic urticaria. A 351(k) application may be filed within the first half of 2024. If approved at that juncture, Celltrion could be positioned for a spell as the only biosimilar entrant to the class.
According to the latest update from ClinicalTrials.gov, Teva’s phase 3 study is expected to be completed in June 2024. Assuming a successful outcome, that may signal an FDA submission in the first or second quarter of 2025.
Kashiv’s ADL018, Alvotech’s AVT23, or Who?
Bear with me here, this is a weird situation, which will take some explanation. A phase 3 trial of Kashiv Bioscience’s ADL018 is slated to be completed in April 2025, which means it may be one of the last to file for approval (perhaps in 2026, after the others have launched). A phase 1 trial of ADL018 was completed in June 2023. A second, smaller phase 1 study was scheduled for completion in August 2023.
In preparation for commercialization, Alvotech signed an agreement October 3, 2023 with Kashiv Biosciences to market ADL018 in most of the world outside of the US. Alvotech refers to the product as AVT23. However, which of its US partners (if any) would market ADL018? Currently, Amneal Pharmaceuticals markets Kashiv’s approved pegfilgrastim and filgrastim biosimilars. Teva, which has an agreement with Alvotech to market the latter’s prospective biosimilars in the US, would be unlikely to compete against its own omalizumab biosimilar by signing an agreement with Kashiv.
Complicating matters further, Alvotech had signed a global licensing agreement in February 2022 with BiosanaPharma to co-develop Biosana’s BP001, which Alvotech also referred to as AVT23. There is no record of BP001 on ClinicalTrials.gov, but there was an allusion to this being a phase 3 product. Something seems wrong here, and it may be my understanding of the situation. BiosanaPharma’s website does not list any financial information (and it may be a privately held company), but its website has no postings since the February 2022 announcement. Will the real AVT24 please stand up?
Aurobindo, primarily a manufacturer of generics, has yet to enter the biosimilar fray in the US. Its phase 1 study is slated to be completed this month. If FDA requires a phase 3 trial for this product, which we think is likely, an initial filing will not be possible before late 2025 (at the earliest).
Glenmark’s GBR 310
A phase 1 investigation was completed in 2018, but Glenmark, a generics maker, has not conducted a later-stage study. It is unclear, based on a July 2018 press release, whether the FDA agreed that the pharmacokinetic and pharmacodynamic study was successful. The product is still listed on Glenmark’s R&D pipeline, but still at the phase 1 stage. One can only assume that this investigational biosimilar is in a holding pattern. Any prediction of progress will have to await a public announcement (no mention of GBR 310 was made on the India-based company’s earnings report).
Barring additional updates, this leaves Celltrion and perhaps Teva as vying for launch in 2026.