Current Edition

Stada and Xbrane gain EU approval for biosimilar Ximluci

The partnership combines Xbrane’s protein-expression system with Stada’s management teams.

Xbrane and Stada have announced that the European Commission has granted marketing authorisation for biosimilar candidate, Ximluci – also known as ranibizumab – which also references Lucentis.

The news follows the positive opinion issued by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) in September this year.

The partnership combines Xbrane’s patented protein-expression system and Europe-based production platform with Stada’s clinical salesforce and key-account management teams.

In 2018, the companies agreed to joint responsibility for the development and manufacturing of the product. Stada holds the marketing authorisations and the commercial rights to the biosimilar across all territories included in the agreement, which covers Europe, the US, several countries in the Middle East and North Africa region, and selected Asia-Pacific markets.

Meanwhile, the centralised marketing authorisation for Ximluci 10mg/ml solution for injection is also held by Stada and is valid in all 27 EU member states, in addition to Iceland, Norway, and Liechtenstein, while the partners are preparing for launches in selected European markets early next year.

Ximluci is a vascular endothelial growth factor that treats retinal vascular disorders, which are a leading cause of blindness globally. The therapy has been approved in the EU for the treatment of wet age-related macular degeneration, diabetic macular oedema, diabetic retinopathy, retinal vein occlusion, and visual impairment in adults.

Stada chief executive officer Peter Goldschmidt reflected: “Having already successfully launched five biosimilars, we are excited to take our rapidly expanding Specialty Care portfolio into an important and growing therapeutic category – ophthalmology. This product authorised through Stada’s strategic partnership with Xbrane will help to increase patient access to biological treatments and optimise the use of healthcare resources.”

“We are proud to have worked with Stada to take this molecule, developed under the XlucaneTM name, from cell-line development to approval and manufacturing via our patented expression system in Europe,” concluded Martin Åmark, chief executive officer of Xbrane. “Clinicians can prescribe Ximluci with the confidence of producing comparable clinical outcomes to the reference product, Lucentis, based on extensive comparative quality studies and clinical data.”

Ranibizumab is the sixth biosimilar approved within Stada’s specialty care portfolio. The other five are adalimumab, bevacizumab, epoetin zeta, pegfilgrastim, and teriparatide.