Alvotech Enters Licensing Agreement With BiosanaPharma for Development of Biosimilar for Xolair

Alvotech Holdings announced today it has entered into a global licensing agreement with BiosanaPharma for the co-development of a proposed biosimilar, AVT23, for the reference product Xolair (omalizumab). The announcement was made in a joint statement by the 2 companies.

Omalizumab is an antibody that targets free IgE and helps control of symptoms from several chronic conditions, including allergic asthma, long-term spontaneous urticaria (itchy rash) in patients with elevated IgE who do not respond to treatment with antihistamines, and nasal polyps in adults when corticosteroids do not offer enough relief.

Xolair, the only currently approved product containing omalizumab, was first approved in 2003. AVT23 is an investigational compound and has not received regulatory approval in any country.

The proposed biosimilar AVT23 would be produced using BiosanaPharma’s proprietary 3C process technology, which the companies said allows for “highly productive, low-cost manufacturing.”

“This transaction underscores Alvotech’s comprehensive approach to the biosimilars market,” Mark Levick, CEO of Alvotech, said. “Our pure-play biosimilars approach allows the Alvotech platform to be highly opportunistic in not only developing products in-house, but also through in-licensing and co-developing attractive products through partnerships with premier companies like BiosanaPharma.”

“We are delighted at this collaboration with Alvotech as their platform can enable global distribution of our lead product, if approved,” said Ard Tijsterman, CEO of BiosanaPharma. “Our 3C process technology is designed to make products more affordable and to improve patient access, a key goal for both BiosanaPharma and Alvotech.”

“The cooperation between our companies demonstrates the ability of our platform to rapidly scale our portfolio,” said Anil Okay, Chief Commercial Officer of Alvotech.“This product had been on our wish list for some time and expands the breadth and potential of our future offerings in primary care.”

Under the agreement, Alvotech will receive exclusive global rights for AVT23, a proposed biosimilar to Xolair. BiosanaPharma will receive an upfront payment and will be eligible for certain tiered royalties. BiosanaPharma and Alvotech will jointly continue development of AVT23, currently in late-stage development. BiosanaPharma has completed a pharmacokinetic (PK) study showing that AVT23’s bioavailability, safety, tolerability and immunogenicity were comparable to those of Xolair.

Global sales of Xolair are currently estimated at $3.3 billion.

Alvotech, based in Iceland, focuses on development and manufacture of biosimilar medicines. The company’s pipeline includes 8 candidates for treating autoimmune disorders, eye conditions, osteoporosis, and cancer. BiosanaPharma, with operations in Australia, the Netherlands, and Singapore, aims to increase affordability by using its proprietary 3C process.