STADA and Xbrane weigh options for ranibizumab biosimilar candidate

Wednesday, July 26, 2023, 

STADA Arzneimittel AG and Xbrane Biopharma AB are considering options, including out-licensing, for their co-developed ranibizumab biosimilar candidate in North America.

The two companies and previous commercialization partner, Bausch + Lomb, have mutually agreed to discontinue their license agreement for North America. Bausch + Lomb will now focus on other strategic priorities. An upfront payment of US$ 5 million made by Bausch + Lomb in 2020 is non-refundable, but no further payments will be made to STADA and Xbrane.

Having already launched their cost-effective biosimilar ranibizumab in several European markets following EU approval in November 2022 under the Ximluci brand name, STADA and Xbrane remain fully committed to making this medicine available to patients and ophthalmologists in the US. The partners are currently exploring all options, including licensing to an external commercial partner, as well as commercializing the product themselves.

“Our focus is on working with the US regulatory authorities to obtain marketing authorization for ranibizumab and enabling patient access,” explained STADA’s head of global specialty, Bryan Kim. “At the same time, we are accelerating the launch of our Ximluci ranibizumab biosimilar in Europe.”

In the US, the partners’ biosimilar ranibizumab candidate, which references the Lucentis brand, was filed with the US Food and Drug Administration (FDA) in June 2023, with a Biosimilar User Fee Amendments (BsUFA) action date of 21 April 2024.

“Given that biosimilar competition is just forming in the approximately US$ 8 billion anti-VEGF market for retinal disorders in North America, we see significant opportunities to improve patient access,” stated Xbrane’s CEO, Martin Åmark. “We are confident that our ranibizumab biosimilar candidate leveraging Xbrane’s patented platform technology has high production yields that can minimize manufacturing costs and ensure a cost-competitive, high-quality therapeutic option.”

In Europe, where the ranibizumab biosimilar in November 2022 received a marketing authorization valid throughout the European Union under the Ximluci brand name, STADA and Xbrane continue to facilitate patient access. The product has already been launched in several European countries, with more to be added over the coming months.

STADA Arzneimittel is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of generics, specialty pharma and consumer healthcare products.

Xbrane Biopharma AB develops biological drugs based on a patented platform technology that provides significantly lower production costs compared to competing systems.

PHARMABIZ.com