FDA rejects Biocon insulin biosimilar over data, manufacturing concerns

Biocon, an Indian biopharmaceutical company, has received a setback as its insulin biosimilar, Semglee, has been rejected by the U.S. Food and Drug Administration (FDA) over data and manufacturing concerns. Semglee, a biosimilar of Sanofi’s Lantus, is intended to treat Type 1 and Type 2 diabetes by controlling blood sugar levels. This rejection highlights the critical role of data and manufacturing quality in gaining approval for biosimilars. In this blog, we will focus on the key points surrounding the FDA’s rejection of Biocon’s Semglee insulin biosimilar.

Key Points

Here are the key points regarding the FDA’s rejection of Biocon’s insulin biosimilar, Semglee:

1. Biosimilar Overview:

Biosimilars are biological drugs that are similar to existing approved reference biologics, with demonstrated comparable quality, safety, and efficacy. Biosimilars are developed to offer lower-cost alternatives to existing biologics.

2. Biocon’s Semglee:

Biocon’s Semglee is a biosimilar version of Sanofi’s Lantus insulin, a long-acting insulin used to treat diabetes. Semglee was intended to offer a lower-cost alternative to Lantus for diabetes patients.

3. FDA Rejection:

The FDA has rejected Biocon’s application for Semglee, citing data and manufacturing concerns. The decision was based on review of the clinical data submitted by Biocon. The rejection raises concerns about the quality and consistency of the manufacturing process and the accuracy and validity of the data used to support the application.

4. Manufacturing Concerns:

Manufacturing of biosimilars is a complex process, and maintaining consistency and quality is critical to ensure the biosimilar’s safety and efficacy. The FDA’s rejection highlights the importance of rigorous manufacturing processes for biosimilars and the need for biopharmaceutical companies to have reliable procedures in place during manufacturing.

5. Data Accuracy:

Data accuracy is necessary to support claims of biosimilarity between a proposed biosimilar and its reference biologic. The FDA’s rejection of Biocon’s Semglee underscores the importance of accurate, reliable data to establish biosimilarity and the need for data to meet regulatory standards to gain FDA approval.

6. Future Outlook:

The rejection of Biocon’s Semglee is a setback for the company, but it highlights the need for biopharmaceutical companies to prioritize data and manufacturing quality when developing biosimilars. The FDA’s decision also emphasizes the agency’s commitment to patient safety and the need for demonstrable quality and safety in biosimilar development.


The FDA rejection of Biocon’s Semglee biosimilar for insulin treatment highlights the importance of data quality and manufacturing standards in biosimilar development. The rejection underscores the need for rigorous manufacturing process controls and accurate data to support the proposed biosimilarity of a biosimilar to its reference biologic. The decision highlights the FDA’s commitment to patient safety and its stringent requirements for biosimilar approval. Although the rejection of Semglee is a setback for Biocon, it provides a valuable lesson for the biopharmaceutical industry, highlighting the importance of prioritizing quality and safety when developing biosimilars.