Seeking to become the second omalizumab biosimilar to be approved in the US, Amneal Biosciences and Kashiv BioSciences announced on September 26 that they had filed a biologic licensing application for the approval of their biosimilar candidate ADL-018.
“The earlier-than-expected BLA submission for this important therapeutic is excellent news for Amneal, as this product represents a significant potential growth catalyst in the coming years,” said Andy Boyer, Executive Vice President and Chief Commercial Officer, Affordable Medicines at Amneal Pharmaceuticals. “We are excited about the opportunity to be part of the first wave of omalizumab biosimilars in this large and attractive market. Alongside our three marketed biosimilars, we expect another five biosimilar launches from 2026 to 2027, including our biosimilar to XOLAIR, positioning biosimilars as a key growth driver for Amneal.”
The first omalizumab launch is not expected until September 2026, based on Celltrion’s settlement for its product Omlyclo with reference drug maker Genentech.
In Other Biosimilar News
Celltrion announced on October 2 that it has launched its intravenous (IV) formulation of Avtozma, a tocilizumab biosimilar. BR&R confirmed with Celltrion that the subcutaneous form, which is also approved by the FDA, has not yet launched; Celltrion has an undisclosed, agreed-upon launch date for the subcutaneous form of Avtozma, as part of the settlement with the reference manufacturer. There are currently three tocilizumab biosimilars available.
Formycon AG reached a settlement with Regeneron, which will allow it to launch Ahzantive, its aflibercept biosimilar no later than the fourth quarter of 2026. At least two other biosimilar makers have approved aflibercept biosimilars that will launch in the latter half of 2026 on the basis of patent agreements; however, Amgen’s Pavblu has been marketed since October 2024.
(Editor’s Note: This post was updated on October 3, with further information from Celltrion.)
