The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) over manufacturing issues for a new drug application filed by Biocon and Mylan for a biosimilar to Sanofi’s diabetes drug, Lantus (insulin glargine). The FDA issued the CRL pending completion of corrective and preventive actions (CAPAs) submitted to the FDA in response to observations made at the conclusion of a pre-approval inspection of the company’s insulin- manufacturing facility in Malaysia in June 2019. 

In a company statement, Biocon said the CRL does not impact its commercialization plans for the product. “The CRL did not identify any outstanding scientific issues with the application,” said the company in an August 31, 2019 statement. “We remain confident of the quality of our application and do not anticipate any impact of this CRL on the commercial launch timing of our Insulin Glargine in the U.S.”

Lantus (insulin glargine) is one of Sanofi’s top-selling drugs with 2018 sales of EUR 3.565 billion ($3.935 billion) and is one of several biosimilars in which Biocon and Mylan are developing.  Biocon is partnered with Mylan for the development, manufacturing, supply, and commercialization of up to six proposed biosimilars, which includes: insulin analogs; trastuzumab, the active ingredient in Roche’s cancer drug, Herceptin; and pegfilgrastim, the active ingredient in Amgen’s Neulasta, a leukocyte factor for treating neutropenia, or low white blood cell count, in patients with certain types of non-myeloid cancers.

“We remain committed to global standards of Quality & Compliance and are working closely with our Partner and the regulator to complete these CAPAs to the satisfaction of the U.S. FDA,” said Biocon in its statement.

In a separate development, Biocon further reported that the FDA completed a surveillance cGMP inspection of one of its biologics drug-product manufacturing facilities in Bengaluru, India, with the agency reporting four observations. The inspection occurred from August 22 to August 30, 2019.  “The inspection concluded with four observations which we believe will not impact supplies from this facility,” said Biocon in its statement. “We are confident of addressing these observations through a Corrective and Preventive Action plan in a timely manner.”

Source: Biocon