Biocon Biologics's Hulio biosimilar to Humira, now available in US

Biocon Biologics, which recently announced its acquisition of Viatris’ global biosimilars business, has secured multiple biosimilar approvals in the U.S., Europe, and over 100 countries across the globe.

“The launch of HULIO, our biosimilar adalimumab, in the United States is an important milestone for Biocon Biologics as it expands our well-known biosimilar product offering to patients in the United States. This launch builds on our strong presence in oncology and diabetes and re-affirms our commitment to enabling affordable access to biologics,” said Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd.

“Biocon Biologics is pleased to make HULIO, a patient-friendly, 2-click, prefilled pen available in the United States for patients with certain inflammatory diseases. There are no buttons to push. Patients remove the cap and push the device against their skin to trigger their injection. Designed and built with patients in mind, healthcare professionals and patients don’t have to miss a beat with HULIO; they simply, ‘Click, Click, Go,’” said Mathew Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics Ltd.

"To provide broad access for patients, Biocon Biologics is offering two options to health plans and pharmacy benefit managers," the company stated. HULIOis available at a list price (Wholesale Acquisition Cost) of 5% below the current Humira list price. Adalimumab-fkjp is also available at a list price of approximately 85% below the current Humira list price.

HULIO meets the rigorous biosimilar approval standards of the FDA. Like Humira, HULIO is citrate-free and is made without natural rubber latex (to help reduce hypersensitivity reactions). Biocon Biologics also offers HULIO360, a robust patient support program, which includes benefits verification and prior authorization support, copay assistance, a bridge program for eligible patients, and at-home nurse injection training.

HULIO is a registered trademark of Fujifilm Kyowa Kirin Biologics Co., Ltd., licensed to the Viatris Companies. Effective November 29, 2022, Viatris completed the sale of substantially all of its biosimilars portfolio (including related product trademarks) to Biocon Biologics Limited and its subsidiaries (“Biocon”) and the relevant marketing authorizations are in the process of being transferred. Viatris Inc. and its subsidiaries are not affiliates of Biocon but are providing certain transition services to Biocon following the transaction completion date, such as operating websites (including this site) relating to the biosimilars portfolio on Biocon’s behalf.

Hulio360 is a trademark of Fujifilm Kyowa Kirin Biologics Co., Ltd., licensed to Biosimilar Collaborations Ireland Ltd., a Biocon Biologics company.

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