BRIEF—Biocon plant clears FDA inspection; EU biosimilar Fulphila opinion

Indian drugmaker Biocon says that the US Food and Drug Administration conducted a periodic current Good Manufacturing Practices (cGMP) inspection of its drug substance manufacturing site at Bangalore Campus from September 17 to 21, 2018.

The weeklong audit concluded without any observations and no Form 483 was issued.

“The successful audit of this site reflects our strong commitment to cGMP compliance,” said a company spokesperson.

Along with partner Mylan, Biocon has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of  Fulphila, a biosimilar to Amgen’s Neulasta (pegfilgrastim).

Fulphila was approved by the US FDA earlier this year and is the first FDA-approved biosimilar for Neulasta in the USA, the companies noted.

Regulatory applications for Fulphila have also been submitted in Australia, New Zealand, Canada and several other countries.