FDA rejects Biocon insulin biosimilar over data, manufacturing concerns

Less than a year after buying out the biosimilar franchise of Viatris, Biocon has received a complete response letter from the FDA for its biosimilar version of insulin aspart. 

The agency's letter cites the need for additional data and corrective measures at manufacturing facilities in Bengaluru, India. The FDA conducted a preapproval inspection of the site in August.  

“We are in the process of comprehensively addressing the CRL,” Biocon said in a brief statement revealing the rejection.

In an interview with CNBC, Biocon’s chair Kiran Mazumdar-Shaw said there was no timeline for resubmission. The company did not plan on launching the biosimilar—a copycat of Novo Nordisk’s NovoLog—until later this year, so there shouldn’t be much disruption in Biocon’s plan, Shaw added.

An August inspection of two Biocon biosimilar manufacturing facilities in Bengaluru produced 11 observations at each. Also in August, an inspection of a Biocon plant in Malaysia turned up six issues.  

"The observations primarily relate to the 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, plus other procedural and facility upgrades,” the company said at the time.

Biocon already produces Semglee, a biosimilar for Sanofi’s insulin Lantus, which scored U.S. approval (PDF) in June of 2021 and launched two months later.

The approval was historic for Biocon and Viatris as the partners secured the first insulin biosimilar blessed with “interchangeable” status at the FDA. The designation allows pharmacists to substitute the copycat product for the branded version at the pharmacy counter without a doctor's consent. 

In February of last year, Biocon bought Viatris’ biosimilars business for $3.3 billion. The two companies had already partnered on several biosimilar products, with Biocon handling R&D and manufacturing and Viatris the commercialization.