Title: Biocon and Viatris Encounter Hurdles in Approving Bevacizumab BLA
Introduction:
Biocon and Viatris’ application for the biologics license of Bevacizumab, a cancer-treating drug, faced a setback with the issuance of a Complete Response Letter (CRL) by the FDA. In this blog post, we will look into what the CRL means, the reasons behind the delay, and what it means for Biocon and Viatris.
Key Points:
- The Issuance of a Complete Response Letter:
The FDA issues a Complete Response Letter (CRL) to indicate that its review is complete, but the application cannot be approved in its present form. The CRL could arise due to deficiencies in the application, unanswered questions, or inadequate trials to support safety and efficacy. - Reason for CRL:
The CRL issued by the FDA addressed specific deficiencies in the application and is not related to the product’s shortcomings. Viatris, a global healthcare firm, and Biocon, an Indian biopharmaceutical company, had difficulty answering concerns about specific plant inspections, the pandemic’s impact on the manufacturing process, and the product’s quality and control system. - Deadline for Resubmission:
Biocon and Viatris will be required to respond to the FDA’s request for supplemental information to address concerns raised by the regulators, resulting in a delay in the approval process. They aim to comply with the FDA’s request promptly to be able to resubmit the application. - Implications of CRL:
Biocon and Viatris have invested significant resources into the development and production of the biosimilar, and the delay in the FDA approval process is a disadvantage. The delay could also provide an opportunity for competitors who may enter the market and gain an advantage. - Future Perspectives:
The issuance of a Complete Response Letter is not uncommon, and resubmission of the application with supplemental data is a normal process. Biocon and Viatris will collaborate closely with the FDA to address any concerns and work towards FDA approval. If successful, Bevacizumab would be a boost to cancer patients in the US who could benefit from the biosimilar’s unique properties. - Conclusion:
Biocon and Viatris faced a delay in their bid to license Bevacizumab due to the issuance of a Complete Response Letter. The delay is due to issues with application deficient as well as challenges caused by pandemic-related production issues. The resubmission process will take time, but the end results are expected to be a boost to patients as the biosimilar is known to be effective in treating cancer.