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Biocon, Ltd.

http://www.biocon.com/

Latest From Biocon, Ltd.

Onward Ho: Biocon Signals Glargine Build Up, US Biosimilars Pricing ‘Sanity’

Biocon anticipates significant US uptake of its Viatris-partnered interchangeable insulin glargine biosimilar on the back of commercial arrangements in place and expects to "move the market" in 2022. All eyes are also on the trajectory of biosimilar insulin aspart, which received a CRL from the US FDA.

Sales & Earnings Strategy

Onward Ho: Biocon Signals Glargine Build Up, US Biosimilars Pricing ‘Sanity’

Biocon anticipates significant US uptake of its Viatris-partnered interchangeable insulin glargine biosimilar on the back of commercial arrangements in place and expects to "move the market" in 2022.  All eyes are also on the trajectory of biosimilar insulin aspart, which received a CRL from the US FDA.

Commercial Biosimilars

US FDA GMP Warnings To OTC Firms In China, South Korea

Cosmo Bio's response to remote records request shows the South Korea company was marketing an unapproved OTC acne treatment without adequate release or stability testing. In China, Hubei Kangzheng was manufacturing an ophthalmic in a Grade D area without appropriate microbial controls.

Warning Letters OTC Drugs

The Quality Lowdown: More Inspection Delays, More Findings On Sterility And Investigations

US FDA hits firms in New Jersey, South Korea and China with warning letters. Meanwhile, Catalent and several outsourcing facilities work on Form 483 inspection findings as Mylan, Viona and Lohxa announce drug recalls.

Manufacturing Quality
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    • Biocon Sdn Bhd.
    • Biocon Limited
    • Biocon Biologics India Ltd
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