Biocon Gets FDA Inspection Clearance for Unit at Bengaluru

Updated on
  • Regulator has asked for some voluntary improvements at plant
  • Brings company step closer to making biosimilar drugs for U.S.

Biocon Ltd. has received U.S. Food and Drug Administration clearance for the sterile products unit of its Bengaluru facility, a sign of progress in its bid to bring the plant up to regulatory standards and be among the first wave of a new class of biologic drugs in the U.S.

The regulator issued a report asking for some voluntary improvements at the facility but said the inspection conducted between May 25 and June 3 is closed, according to a Biocon statement on Monday. The drugmaker still needs to deal with a separate inspection concluded April 7 of its Bengaluru plant, which resulted in the FDA issuing a Form 483 that noted eight potential violations in its manufacturing standards.

Manufacturing issues at the Bengaluru plant have proved a stumbling block in Biocon’s efforts to be among the first to sell copies of complex biologic medicines in the U.S. and European markets. The Indian company was forced to withdraw and resubmit applications to sell its copies of two cancer drugs in Europe after inspectors found potential problems at the Bengaluru plant, and U.S. approval for one of the drugs, pegfilgrastim, has been delayed because of corrective actions sought by the FDA.

Shares of Biocon rose 7.3 percent to a record 423.20 rupees at the close in Mumbai. The benchmark S&P BSE Sensex was little changed.

Biologic drugs are manufactured from substances in living cell, making them uniquely challenging to reproduce. Cheaper versions of these drugs, called biosimilars, are becoming a more important part of the world’s medicine cabinets.

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