Biocon’s insulin glargine suffers setback in US as FDA issues a second CRL | 06 September, 2019

Only two weeks back, Biocon’s insulin operations in Malaysia had won a certificate of good manufacturing practice from European Medicines Agency’s Irish inspection authority and it had seemed like the Indian drugmaker had turned a corner in quality.

But the company announced over the weekend that the Mylan and Biocon combine have been issued a second Complete Response Letter (CRL) by the FDA for their follow-on insulin glargine product referencing Lantus.

Mayank Verma, the company’s secretary and compliance officer, said in a letter to the National Stock Exchange of India, dated August 31, 2019: “The 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.

Back in June 2018, Biocon and Mylan had received a CRL following an earlier pre-approval inspection. In that case, the FDA asked for additional clinical data to support a request to manufacture the insulin injectors at the Malaysia facility instead of making it at a plant in Bangalore, India.

Prior to the initial CRL, the company had received a Form 483 from the FDA, inclusive of six observations, after an inspection of the Malaysia facility. Another inspection of the site in June and July 2019 had yielded another Form 483 with 12 observations.

(Source: PharmaCompass)