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# Inspection Troubles Hit Biocon’s Avastin Biosimilar
- URL: https://www.fdaweb.com/inspection-troubles-hit-biocons-avastin-biosimilar/
- Published: 2023-02-13T12:00:00.000Z
- Updated: 2026-09-14T18:15:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153765

FDA has issued India’s Biocon Biologics a complete response letter on its BLA for a biosimilar version of bevacizumab (Genentech’s Avastin), which is indicated for treating six cancer types: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

FDA’s letter cited the company’s need to resolve inspection observations made during a facility inspection 8/2022\. “We have submitted a comprehensive corrective and preventive action plan to the agency and are confident of addressing the observations within the stipulated timeframe,” the company says, adding that the letter did not identify any outstanding scientific issues with its BLA. Last month, the agency issued the company a similar complete response letter on its BLA for a biosimilar version of insulin aspart ([see earlier story](https://www.fdaweb.com/biocon-complete-response-letter-on-insulin-biosimilar/)).

Last year, FDA released three Form FDA-483s issued to Biocon Biologics following three on-site August 2022 inspections at the company’s seven manufacturing sites in Bengaluru, India, and Johor, Malaysia. Biocon says the inspections were triggered by three preapproval inspections for biosimilar bevacizumab, rh-insulin, and insulin aspart, and a capacity expansion for biosimilar trastuzumab. “These included multiple drug substance and drug product facilities and other support infrastructure at these sites,” the company said at the time.

The FDA-483s show 11 inspection observations each for the two Bengaluru sites and six observations for Johor. They indicated a need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications and computerized tools to aid risk assessment and investigations, and other procedural and facility upgrades. The FDA-483s are available below:

[Biocon Sdn](https://www.fda.gov/media/161811/download?ref=fdaweb.com). Johor, Malaysia  
[Biocon Biologics](https://www.fda.gov/media/161809/download?ref=fdaweb.com)Bommasandra-Jiganis Link Road, Bengaluru, India  
[Biocon Biologics](https://www.fda.gov/media/161810/download?ref=fdaweb.com)20th KM Hosur Road, Bengaluru, India