Biocon’s facility in Bangalore, India, has failed to pass muster with the US FDA, raising questions on whether this could result in a pushback of commercialization timelines for partner Mylan’s biosimilar pegfilgrastim in the US. The European regulator has also not cleared the Bangalore site.
Biocon’s shares were under pressure on Indian bourses after the company’s sterile drug product manufacturing facility in Bangalore failed to make the compliance cut in a pre-approval inspection by the US FDA. Compliance deviations at the Bangalore site were also flagged up by the European regulator, dealing a double blow to the Indian firm.
The disappointing compliance outcome comes at a critical juncture in the run up to the June 4 FDA action date...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
