Drugs

Inspection Troubles Hit Biocon’s Avastin Biosimilar

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).

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. Johor, Malaysia
Biocon BiologicsBommasandra-Jiganis Link Road, Bengaluru, India
Biocon Biologics20th KM Hosur Road, Bengaluru, India

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome