Biocon Biologics' biosimilar sites cleared by FDA
The two sites in question are based in Bangalore, India, and are involved in the manufacture of drug product for two biosimilars, trastuzumab and pegfilgrastim.
Biocon Biologics’ sites were inspected by the US Food and Drug Administration (FDA) in September 2019, during which the agency raised eight observations.
The agency’s work came as part of a pre-approval inspection for the facilities, though Biocon responded at the time saying that the observations would not impact commercialization of products associated with the facilities.
Now, the company has announced that it has been given the all-clear, after the receipt of an establishment inspection report signifying the closure of the inspection.
In a statement, Biocon Biologics said that this closure would allow for filing of marketing authorization applications for its biosimilar products in ‘several global markets’.
At the time of writing, shares in Biocon were up by 4.2% on the news.
Earlier this year, Biocon Biologics received Rs 536.25 Crore ($75m) in investment by True North. The injection of cash values the business at approximately $3bn, as it moves ahead with plans to grow its annual revenues to $1bn by 2022.
A core part of its plan in this regard are the biosimilars that it has partnered with Mylan on, which saw the two companies launch Fulphila (pegfilgrastim), also known by its brand name Neulasta, in Australia earlier this week.