Bevacizumab, Aspart Compliance Update

Compliance issues have set back BBL's launch plans for both bevacizumab and aspart in the US.

“The bevacizumab CRL [Complete Response Letter] requires us to address the observations made during the site inspection for which we have submitted a Corrective and Preventive Action (CAPA) plan and are awaiting a response,” Mazumdar-Shaw said on the Q3FY23 earnings call. (Also see "Three Years After US Filing, Biocon’s Bevacizumab Remains Out Of Reach" - Generics Bulletin, 13 February, 2023.)

Earlier this month, Biocon said that the bevacizumab CRL informs the need for a satisfactory resolution of the observations made during the facility inspection (in Bengaluru, India) by the agency in August 2022.

On insulin aspart, Mazumdar-Shaw maintained that the US FDA had accepted the firm’s CAPA plan pertaining to the pre-approval inspection of the product at the site in Malaysia, which was cited in the CRL. (Also see "Biocon Insulin Aspart US Opportunity: 'Not Completely Lost But Not The Best Situation'" - Scrip, 5 August, 2022.) (Also see "Biocon And Viatris Get CRL From FDA On Insulin Aspart" - Generics Bulletin, 10 January, 2022.)

"We are confident of being able to resolve the asks from US FDA," she added.

The FDA had in August last year conducted three on-site inspections of BBL’s seven manufacturing facilities spanning two sites in Bengaluru and one at Johor, Malaysia.

The inspections had been triggered on account of three pre-approval inspections for biosimilar bevacizumab, rh-insulin and insulin aspart and a capacity expansion inspection for biosimilar trastuzumab. They included multiple drug substance and drug product facilities and other support infrastructure at these sites.

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