Eye on Pharma: Xbrane and STADA to Develop Ranibizumab Biosimilar

Xbrane Biopharma and STADA have announced that they have entered into a collaboration agreement for the development of a ranibizumab biosimilar, referencing Lucentis, which will prospectively be sold as Xlucane, in the US, European, and other markets.

The agreement stipulates that each organization must equally contribute to development expenses and share profits from commercialization of the potential biosimilar in an equal split. Additionally, STADA will make an upfront payment to Xbrane of approximately $8.7 million (€7.5 million).

“The co-development deal with STADA is a significant achievement and opportunity for Xbrane which confirms Xbrane’s unique capabilities and competencies in biosimilar development,” said Anders Tullgren, chairman of the board of directors at Xbrane, in a prepared statement.

Xbrane will be responsible for developing the biosimilar until submissions for regulatory approval are made to the European Medicine’s Agency (EMA) and the FDA. STADA will hold the marketing authorizations and will also be accountable for the sales and marketing of the product across all territories included in the agreement (Europe, the United States, the Middle East and North Africa, and Asia).

The organizations have indicated that they are ready to move forward with the initiation of a phase 1 and phase 3 clinical trial, and say that they have agreed on the study design with both the EMA and FDA. The study will enroll patients with wet age-related macular degeneration across 16 countries.

“The deal will contribute significant funding and expertise for the development and commercialization of Xulcane and will help to accelerate the development of our pipeline of biosimilars, as well as the transformation of Xbrane into a major player in the fast-growing global biosimilars market,” said Tullgren.