One of the more confusing situations in the world of the biosimilar pipeline was the status of Kashiv BioScience’s omalizumab biosimilar candidate. On July 2, the company announced that Amneal Pharmaceuticals has agreed to commercialize ADL018 once approved in the US.
We reported in November 2023 on the progress of omalizumab biosimilars through research and development. There was a tangled web of nomenclature as well as relationships for Kashiv’s ADL018, foremost being between Kashiv and Alvotech, which signed an agreement for the marketing rights to this Xolair® biosimilar outside of the US. Alvotech refers to the investigational product as AVT23. Interestingly, Alvotech also had a global licensing agreement to market another company’s omalizumab biosimilar (BP001 by Biosana), which Alvotech also referred to as AVT23. The phase 3 clinical trial of ADL018 is scheduled to be completed in the second quarter of 2025.
Conveniently, Amneal actively markets two biosimilars for Kashiv in the US—Releuko® (a filgrastim biosimilar) and Fylnetra® (a pegfilgrastim biosimilar). In a press release, Sean McGowan, Vice President, Biosimilars and Branded Oncology of Amneal said, “We are excited to further grow our biosimilar pipeline with the addition of omalizumab and expand into a new therapeutic area beyond oncology. We are building on the strong success of our first commercial biosimilars. Amneal is committed to providing affordable biologic medicines which will increase access and choice to patients and providers, and drive cost savings to the US healthcare system.”
Roche reported US 2023 revenues of Xolair to be $2.4 billion, which does not represent sales based on a new, significant indication: the treatment of food allergy.
For Amneal, this marks the eighth biosimilar in its portfolio of approved products and investigational drug candidates.
