Xbrane Biopharma AB has resubmitted its Biologics License Application (BLA) for its ranibizumab biosimilar candidate to the U.S. Food and Drug Administration (FDA), addressing concerns raised in a previous Complete Response Letter (CRL).
The Swedish biopharmaceutical company initially submitted the BLA for its LUCENTIS (ranibizumab) biosimilar in April 2023 but received a CRL from the FDA in April 2024. The regulatory agency requested additional information regarding the reference standard and follow-up actions from pre-approval inspections conducted at manufacturing partners' facilities.
In response, Xbrane has qualified a new reference standard after alignment with the FDA and collaborated with its contract manufacturers to complete the requested follow-up actions. The typical review cycle for a resubmitted BLA is approximately six months, potentially positioning the company for a decision by early 2025.
Addressing Regulatory Requirements
The resubmission represents a critical milestone in Xbrane's development program for its ranibizumab biosimilar. Biosimilar approval processes are rigorous, requiring manufacturers to demonstrate that their products are highly similar to the reference product with no clinically meaningful differences in terms of safety, purity, and potency.
"We have worked diligently to address the FDA's requests regarding the reference standard and manufacturing site inspections," said a representative from Xbrane Biopharma. "Our team has collaborated closely with regulatory authorities and manufacturing partners to ensure all requirements are met for this resubmission."
Market Impact and Patient Benefits
Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor used to treat several serious eye conditions. The original product, LUCENTIS, developed by Genentech (a member of the Roche Group), has been a mainstay treatment for retinal disorders since its approval.
If approved, Xbrane's biosimilar would provide a cost-effective alternative for patients suffering from age-related macular degeneration (AMD), retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV). These conditions affect millions of patients globally, with AMD alone being a leading cause of vision loss in people over 50.
The introduction of biosimilars to the ophthalmology market could significantly reduce treatment costs while maintaining efficacy and safety profiles comparable to the reference product. This is particularly important for conditions like AMD that require regular injections over extended periods.
Biosimilar Landscape in Ophthalmology
The ophthalmology market has seen increasing interest in biosimilar development as patents for original biologics expire. Ranibizumab biosimilars represent an important addition to the treatment landscape, potentially increasing access to sight-saving therapies.
Biosimilars typically enter the market at prices 15-30% lower than reference products, though the actual cost savings can vary based on market dynamics and healthcare systems. For chronic conditions requiring ongoing treatment, these savings can be substantial for both patients and healthcare systems.
Xbrane has positioned itself as a developer of high-quality, cost-effective biosimilars, with its ranibizumab candidate being a key asset in its portfolio. The company utilizes its patented protein expression platform to develop biosimilars with high yield and quality.
Looking Forward
With the resubmission complete, Xbrane now awaits the FDA's review, which typically takes approximately six months for resubmitted applications. The company has expressed its commitment to advancing the biosimilar candidate toward approval in the United States as quickly as possible.
If approved, the product would join a growing market of ophthalmic biosimilars aimed at expanding treatment options while reducing healthcare costs. For patients with serious retinal conditions, the availability of additional treatment options could improve access to sight-preserving therapies.
The development and potential approval of Xbrane's ranibizumab biosimilar highlights the evolving landscape of biosimilar medications and their increasing importance in specialty therapeutic areas like ophthalmology.
