Latest From Biocon Ltd.
The latest US drug development news and highlights from our Performance Tracker.
Baxter, Ariad, Diurnal. Kyowa Kirin and AB Science are among the companies that will shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are under review.
Intas Pharmaceuticals has introduced its biosimilar bevacizumab in India at less than half the innovator product’s price, putting the spotlight on how its competition might tackle the new entrant’s pricing position.
An FDA inspection uncovered a wide-ranging list of GMP problems at biopharmaceutical manufacturer Celltrion in South Korea. Among some of the problems that inspectors found were mold on walls in sterile areas, operators leaning over sterile areas with bare hands and arms, and employees using shared passwords. A resulting Form 483 report is the latest in a number of recent enforcement actions targeting proposed biosimilar drugs.
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