Biocon and Viatris Hit Another FDA Wall with Avastin Biosimilar

After facing a holdup due to COVID-19 restrictions in 2020, Biocon and Viatris face another hurdle to getting their bevacizumab biosimilar, Abevmy, to American markets with the FDA hitting the companies with a Complete Response Letter (CRL) regarding issues with the facilities inspection. Biocon did not disclose specifically what issues led to the CLR, but a company spokesperson said the company had already submitted a Corrective and Preventive Action plan to remedy the problems. 

Continuing Difficulties with the FDA

Biocon and Viatris teamed up back in 2009 when Viatris was still operating under the name Mylan before it teamed up with Upjohn to form Viatris. The partnership aimed to bring generics and biosimilars to markets around the globe. With success in other biosimilar areas, the duo’s cancer biosimilar, Abevmy, has proven to be the most difficult to get into the American market so far.

In December 2020, Biocon and Viatris had everything lined up to get the biosimilar to the market, but travel restrictions due to COVID-19 prohibited the FDA from visiting Viatris’ manufacturing facility in Pittsburgh, causing a lengthy delay in the approval process. 

Over two years later, the FDA slapped the companies with a CLR citing issues during a facility inspection in August 2022. With an action plan submitted to the FDA, the companies hope to resolve the issues to get the biosimilar to American markets. 

The companies have succeeded in other areas despite the trouble getting Abevmy into American markets. In May last year, Viatris announced that Health Canada approved the biosimilar to treat metastatic colorectal cancer, certain kinds of non-small cell lung cancer, certain kinds of epithelial ovarian, fallopian tube, and primary peritoneal cancer, and malignant glioma. 

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Bevacizumab’s Legacy in Oncology

The FDA first approved Roche’s Avastin (bevacizumab) in 2004 to treat advanced colon cancer. Since then, the FDA approved several additional drug indications and two biosimilars in the late 2010s. 

In 2017, the regulatory agency approved Amgen’s Mvasi to treat certain colorectal, lung, brain, kidney, and cervical cancers. The historic approval marked the U.S.’s first biosimilar to treat cancer. 

Two years later, in June 2019, Pfizer received the FDA’s approval for its bevacizumab biosimilar, Zirabev. The second biosimilar also received approval for multiple cancer indications, including colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, and cervical cancer. 

With a history of success in the biosimilar arena, Biocon and Viatris are vying for the third bevacizumab biosimilar with Abevmy. With the most recent CLR, the companies still have their work cut out for them before the drug hits the American market. 

Author

Reed Slater