Early study results indicate that STADA Arzneimittel and Xbrane Biopharma’s ranibizumab biosimilar is as safe and effective as the reference product, suggesting regulatory approval may be on the horizon.
STADA Arzneimittel and its partner Xbrane Biopharma said their ranibizumab biosimilar candidate (Xlucane) has demonstrated comparable efficacy to the originator (Lucentis) in a phase 3 clinical trial.
“We welcome this important step toward bringing a high-quality, cost-effective treatment option to ophthalmologists and their patients,” said Bryan Kim, global head of specialties at STADA, in a statement.
The positive trial results come after STADA launched its bevacizumab biosimilar, Oyavas, in Germany and The Netherlands in April 2021 for the treatment of colon, rectal, breast, epithelial ovarian, fallopian tube, cervical, primary peritoneal, and non-small cell lung cancers.
Ranibizumab is a vascular endothelial growth factor inhibitor used to treat wet age-related macular degeneration (wAMD) and diabetic macular edema.
The randomized, double-masked, multi-center study assessed the pharmacokinetic properties, safety, efficacy, and immunogenicity of the biosimilar in patients with wAMD. In total, 583 patients with wAMD were recruited for the study and randomized to receiving monthly injections of the biosimilar or the reference product for 1 year.
According to a statement from Xbrane, the patients were recruited from 140 clinics in 15 countries.
During the Xplore clinical trial, the biosimilar met the primary end point of equivalent efficacy in best corrected visual acuity after 8 weeks of treatment. Furthermore, there were no clinically meaningful differences between the drugs as measured by pharmacokinetic, immunogenicity, and safety profiles at 6 months.
Xbrane said it will collect additional data on secondary end points during the summer of 2021 and the complete dataset is expected to be published in a scientific journal or presented at a scientific conference as early as 2022.
STADA and Xbrane entered a codevelopment agreement for the biosimilar in July 2018 and per the terms of the agreement, will contribute equally to the development costs and share the profits after approval and marketing. STADA will oversee sales and marketing of the biosimilar in Europe and the companies’ commercialization partner Bausch + Lomb will be responsible for marketing in North America.
Xbrane and STADA are expected to submit an application for marketing authorization in Europe in the third quarter of 2021 and a Biologics License Application to the FDA during the fourth quarter of 2021, according to Xbrane.
“With ranibizumab, STADA’s growing biosimilars presence would extend beyond oncology, nephrology, osteoporosis, and autoimmune indications into the multi-billion-euro eyecare market. We look forward to continuing to work closely with our partner Xbrane on applying for regulatory approval of our biosimilar candidate in major markets,” said Kim.
If Xlucane is approved by European regulatory officials, it may have to compete alongside Samsung Bioepis and Biogen’s ranibizumab biosimilar, Byooviz (SB11), which recently received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use late last month.
STADA Arzneimittel is headquartered in Bad Vilbel, Germany, and Xbrane Biopharma is based in Stockholm, The Netherlands.
Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data
November 5th 2024Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Panelists Stress Stakeholder Education to Build Confidence in Biosimilars
October 31st 2024By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry
Published: October 29th 2024 | Updated: October 29th 2024Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector.