3 September 2019 - Over the weekend, drug maker Biocon disclosed that it and partner Mylan have been issued a second complete response letter for their follow-on insulin glargine product referencing Lantus.

According to Mayank Verma, the company’s secretary and compliance officer, in an August 31 letter to the National Stock Exchange of India, “The complete response letter (CRL) has been issued pending completion of the Corrective And Preventive Actions…submitted to the US FDA in response to the observations made at the conclusion of the pre-approval inspection of our insulin manufacturing facility in Malaysia in June 2019.”

Verma added that the CRL did not note “outstanding scientific issues” with the application, and said that the CRL was not anticipated to have an impact on the company’s planned launch timeline.

Read Center for Biosimilars article