FDA Issues Second Complete Response Letter to Xbrane's Ranibizumab Biosimilar Application

The U.S. Food and Drug Administration has issued a second Complete Response Letter (CRL) to Xbrane Biopharma查看公司主页 AB's Biologics License Application for its ranibizumab查看药品详情 biosimilar candidate, marking another regulatory setback for the Swedish company's efforts to bring a lower-cost alternative to Lucentis查看药品详情 to the American market.

The CRL, received over the weekend, references unresolved observations following a re-inspection of one of Xbrane's contract manufacturers, according to the company's announcement. The FDA provided no further specification regarding the nature of these manufacturing concerns, and no other issues related to the BLA were mentioned in the letter.

Manufacturing Challenges Persist Despite Corrective Measures

This latest regulatory hurdle represents the second CRL for Xbrane's ranibizumab查看药品详情 biosimilar program. The company had initially received a CRL in April 2024 due to observations following inspections at its contract manufacturers' production sites, prompting a resubmission in December 2024.

During the third quarter of 2025, the FDA conducted re-inspections of both production sites involved in manufacturing the drug substance and drug product. Both facilities had submitted thorough evidence of corrective actions addressing the previous observations in a timely manner to the FDA, according to Xbrane.

The company and its contract manufacturer are now awaiting additional communication from the FDA, which typically arrives at the production site within days of a CRL issuance, to better understand the specific approvability requirements.

European Success Demonstrates Product Viability

Despite the U.S. regulatory challenges, Xbrane's ranibizumab查看药品详情 biosimilar has demonstrated successful market performance in other regions. The European Medicines Agency and the UK's Medicines and Healthcare products Regulatory Agency approved the Lucentis查看药品详情 biosimilar in November 2022, with commercial launch beginning in March 2023.

The product has achieved significant market penetration, with close to 200,000 vials shipped to end-users without any reported issues, demonstrating the biosimilar's safety and efficacy profile in real-world clinical settings.

Company Response and Market Impact

"We are very disappointed about the FDA's decision to issue a CRL to our BLA," commented Martin Amark, Xbrane's CEO. "We believe US patients and payors would significantly benefit from a more cost-efficient alternative to existing approved treatments against retinal disorders (搜索)搜索该疾病 and we are committed to work swiftly towards a re-submission of the BLA."

The company currently lacks sufficient information to estimate the timing for resubmission but expects to gain clarity during the coming week. Xbrane plans to address related questions during its upcoming Q3 earnings webcast scheduled for October 24th.

Broader Implications for Biosimilar Access

The regulatory delays highlight the challenges biosimilar developers face in bringing cost-effective alternatives to market, particularly for specialized therapeutic areas like ophthalmology. Ranibizumab查看药品详情 biosimilars represent a significant opportunity to reduce healthcare costs for treating retinal disorders (搜索)搜索该疾病, conditions that require frequent, expensive injections.

Xbrane's biosimilar portfolio targets an estimated EUR 23 billion in annual peak sales of reference products, with the ranibizumab查看药品详情 candidate serving as a key component of this strategy. The company's patented platform technology is designed to provide significantly lower production costs compared to competing manufacturing systems.