Biocon Receives FDA Form 483 at Indian Biosimilar Manufacturing Site
Biocon on Wednesday disclosed that its Bangalore, India-based sterile manufacturing facility received a Form 483 from the US Food and Drug Administration with seven observations."The observations are largely procedural and aimed at continuous improvement. We will respond to the FDA with a corrective and preventive action plan in a timely manner,” Biocon said in a statement. “We have also this week received the preliminary report from the European Regulator post inspection of our sterile drug product facility in Bangalore in March 2018. The report lists 6 major observations with no observation classified as critical. We will submit a corrective and preventive action plan to the European inspection agency within the stipulated time period."
The 483 and comments follow the release of a statement of non-compliance with GMP for the site from French regulators at ANSM in March 2017, and a previous Form 483 in June 2017.
In October 2017, Biocon said it received a complete response letter from FDA for its proposed Neulasta (pegfilgrastim) biosimilar related “to the pending update of the BLA [biologics license application] with certain CMC [chemistry, manufacturing and control] data from facility requalification activities post recent plant modifications.”
The pre-approval inspection by ANSM, on behalf of the European Medicines Agency (EMA), in March 2017 also raised deficiencies concerning three biosimilars made at the site, including Fulphila (pegfilgrastim), Ogivri (trastuzumab) and Semglee (insulin glargine). The ANSM inspection raised 35 deficiencies, including 11 that were categorized as major.
The company's Malaysia-based manufacturing site also received a Form 483 in March.