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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.
Biocon’s oral insulin program has received a boost with the US-based JDRF supporting plans to progress its drug candidate in type 1 diabetes. While the pullback of players like Novo Nordisk underscores the potential risks in the oral insulin space, JDRF says early results of Biocon’s candidate “warrant support” for further studies.
Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.
The FDA has flagged up GMP deviations at Biocon’s Bangalore site, though the company asserts that most of these are procedural blips resulting from ‘heightened’ regulatory expectations. The compliance concerns come ahead of the user fee goal date for Biocon and partner Mylan’s biosimilar trastuzumab next month.
- Large Molecule
- Medical Devices
- Therapeutic Areas
- Parent & Subsidiaries
- Biocon Ltd.
- Senior Management
Arun ` Chandavarkar, PhD, CEO
Siddharth Mittal, CFO
Ravi Limay, Pres., Mktg.
Narendra Chirmule, PhD, SVP & Head, R&D
- Contact Info
Phone: (91) 80 2808 2808
20th KM Hosur Rd.
Bangalore , 560 100
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