Biocon has received the European drug regulatory agency's approval for its facilities in Bengaluru, enabling it to continue and enhance its biosimilar production for the Continent's markets.
The company said on Friday that it has received the Certificate of GMP (Good Manufacturing Practice) compliance from European Medicines Agency (EMA) for its Biologics Drug Product (DP) and Drug Substance (DS) facilities at Biocon Park, Bengaluru. The facilities, which manufacture Biocon’s portfolio of biosimilars, were inspected by the European agency in March 2019.
"This was a surveillance inspection of our existing DP and DS facilities and a pre-approval inspection of our additional DP manufacturing line. This certification will enable us to continue addressing the growing needs of patients in the EU markets and enhance access to our high quality biosimilars,” said company spokesperson in a statement issued today.
The company is expected to deliver growth in the biologics business from product launches in developed and emerging markets, along with a pipeline of biosimilars for launch in future. Analysts earlier said that the growth from biologics business is expected to post double-digit growth both, in revenue and net profit, over the next three financial years, even though competition is expected to grow in future.