Our portfolio of proposed biosimilars


Xbrane develops biosimilars on originator products where we believe we can make a significant difference in terms of improved accessibility with lower pricing. Xbrane has a portfolio of four biosimilar candidates for a range of treatment areas, three of which are under active development. This includes several serious eye diseases, several different types of cancer and, among others, rheumatoid arthritis, psoriasis and Crohn’s disease.

Biosimilar candidateOriginial drugPrimary indicationEstimated annual peak year sales of original drug*Patent expiry of original drugDevelopment phase
Ximluci®Ranibizumab (Lucentis®)Wet age-related macular degeneration, diabetes-related eye damage and retinal vein occlusion.EUR 3 bn*2020 (USA) 2022 (Europe)Launch phase
BIIB801 Certolizumab pegol (Cimzia®)Rheumatoid arthritis, axial spondylitis, psoratic arthritis.EUR 2 bn*2024 (USA) 2025 (Europe)Preclinical phase
Xdivane™Nivolumab (Opdivo®)Skin cancer, lung cancer, renal cell cancer, head and neck cancer and bladder and urinary tract cancer.EUR 13 bn*2026 - 2031 depending on countryPreclinical phase
Xdarzane™Daratumumab (Darzalex®)Multiple melanoma.EUR 9 bn*2029 - 2031 depending on countryPreclinical phase

1Source: *Evaluate Pharma; "Originator Peak Sales Estimate 2026"

Ximluci®


Ximluci® is a biosimilar candidate to ranibizumab, the original drug Lucentis®, a VEGFa inhibitor used to treat a number of serious eye diseases. Ximluci® addresses a market of around EUR 13 bn1 per year. The European Medicines Agency (EMA) approved the European Commission’s recommendation in November 2022 to approve Ximluci® for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), proliferative diabetic retinopathy (POR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV) in 27 mem­ber states in Europe. Ximluci® was launched by Xbrane’s partner STADA Arzneimittel AG (STADA) in Europe during 01 2023. Xbrane submitted a marketing authorization application to the Food and Drug Administration (FDA) and the date of decision on the approval, known as the BsUFA date, is set for April 21, 2024. A marketing authorization application has also been submitted to the regulatory authority in Saudi Arabia. STADA is also actively working to take Ximluci® to other regions such as the Middle East, Latin America and Southeast Asia. Ximluci® is approved in Europe with a vial containing the active substance, from which the ophthalmologist extracts the product into a syringe for injection into the eye. Xbrane is also developing Ximluci® as a prefilled syringe, forwhich additional approval will be sought in the future.

BIIB801


BIIB801 is a biosimilar candidate to certolizumab pegol, original drug Cimzia®, a TNFalpha inhibitor particularly used in the treat­ ment of rheumatoid arthritis and psoriasis. Cimizia®has sales of EUR 2 bn1) and will lose ils patent protection in 2024 in the US and 2025 in Europe. BlIB801is undergoing preclinical development and a cost­ effective production process has been established. An agreement has been signed with AGC Biologics for the manufacture of BIIB801 forfuture clinical studies. In 2022, Xbrane signed a development and commercialization agreement with Biogen lnc., in which Biogen receives full global rights to the product. The agreement means that Biogen has made an up-front payment of USD 8 m and will pay an additional USD 80 m in development and sales-based payments as well as royalties on sales.

Xdivane™


Xdivane™ is a biosimilar candidate to nivolumab, original drug Opdivo®, a PD1 inhibitor for the treatment of various types of cancer. Opdivo® is expected to generate sales of EUR 13 bn and lose its patent protection during 2026–2031 depending on the country. The pilot-scale production process for Xdivane™ is complete and work on transferring and upscaling for the contracted manufacturer is continuing.

Xdarzane™


Xdarzane™ is a biosimilar candidate to daratumumab, original drug Darzalex®, an antibody that binds to CD38 for the treatment of multiple melanomas (around EUR 9 bn in estimated sales). The patent protection of Darzalex® is expected to expire in 2029-2031 depending on the country. Xdarzane™ is at the preclinical development stage with a focus on developing a cost-effective production process and demonstrating a biochemical similarity to the original drug.

Xtrudane™


Xtrudane™ is a biosimilar candidate to pembrolizumab, original drug Keytruda®, a PD1 inhibitor for the treatment of various types of cancer. Development of Xtrudane™ was terminated in November 2023 as a measure to improve the outlook for a positive cash flow.