Biocon Receives Update from USFDA on Bevacizumab Biosimilar Approval

Biocon Ltd today announced that the U.S. Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) for the company’s Biologics License Application (BLA) seeking approval for its proposed biosimilar bevacizumab.

Bevacizumab is an anti-cancer drug used to treat various types of cancers. Biocon has developed a biosimilar version of bevacizumab under the brand name bBevacizumab.

As per the company’s statement, the CRL did not identify any outstanding scientific issues with Biocon’s bBevacizumab dossier. However, the USFDA has asked Biocon to complete a pre-approval inspection of the manufacturing facility where bBevacizumab is produced before the agency can approve the BLA.

Once Biocon completes the pre-approval inspection and addresses any other concerns the USFDA may have, the company can resubmit its BLA for potential approval.

Quoting a company spokesperson, Biocon said it continues to engage with the USFDA and hopes to launch its high quality, affordable biosimilar bevacizumab in the US market soon. The company is a leading global biosimilars player and already has several approved biosimilars in regulated markets.

Biosimilars are drugs that are highly similar to approved biologic drugs with no clinically meaningful differences. They provide more affordable treatment options compared to the original biologic drugs.

The global biosimilars market is expected to grow rapidly in the coming years driven by patent expiries of blockbuster biologics. As per estimates, the global biosimilars market could reach nearly $80 billion by 2030.

Bevacizumab is a monoclonal antibody used in cancer treatment that inhibits angiogenesis, the process by which new blood vessels form to supply tumors with nutrients. It was originally developed by Genentech and is marketed under the trade name Avastin.

Bevacizumab works by blocking vascular endothelial growth factor (VEGF), which plays a key role in angiogenesis. By preventing new blood vessels from reaching and fueling tumor growth, it can slow or stop cancer progression. It was the first approved therapy designed to prevent tumor angiogenesis.

Bevacizumab is used to treat various types of cancers including colorectal, lung, ovarian, cervical, brain, and renal cell carcinoma. It is often used in combination with chemotherapy or other anti-cancer drugs.

While bevacizumab has proven effective for some cancers, it does have side effects including high blood pressure, impaired wound healing, kidney damage, bleeding, blood clots, and rarely, holes forming in the stomach or intestines. Risks and benefits must be weighed on an individual basis.

Overall, bevacizumab represents an important advance in targeting the tumor environment rather than cancer cells themselves. Further research continues to explore optimal use and additional applications. Biosimilar versions also promise to expand access to this significant cancer therapy.