Co-development agreement forms for Lucentis biosimilar

A co-development agreement has been formed by Xbrane Biopharma and STADA Arzeneimittel for the development of Xlucane — a biosimilar to Lucentis (ranibizumab), which is mainly used for the treatment of wet age-related macular degeneration (AMD).

Under the terms of this agreement, Xbrane will be responsible for the development of the product until completion of the marketing authorisation applications to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) and for the supply of the finished pharmaceutical product.

STADA will hold the marketing authorisations and be responsible for sales and marketing of the product across all territories that are included within the agreement — Europe, US and a variety of MENA and APAC markets.

To enter the agreement, STADA was required to make an upfront payment to Xbrane of €7.5 million.

“We are very excited to enter into this co-development partnership with STADA,” said Martin Åmark, CEO of Xbrane. “STADA is a strong player and has long experience in distributing and marketing biosimilars. We could not have found a better partner to help develop and commercialize Xlucane.”

“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,” commented Anders Tullgren, chairman of the board of directors at Xbrane. “The deal will contribute significant funding and expertise for the development and commercialisation of Xlucane 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.”

“The collaboration with Xbrane, with its team of very experienced development experts, is a great opportunity for STADA to accelerate the expansion of our biosimilar portfolio and to strengthen our market position in this segment,” added STADA CEO Dr Claudio Albrecht.

Xbrane is a biopharmaceutical company that specialises in high demand biosimilars and long acting injectables. STADA is an international company that focuses on the healthcare market.