There has been successful closure of US Food and Drug Administration (FDA) inspections at Biocon Biologics sites in Malaysia and India. Three manufacturing sites were issued FDA establishment inspection reports (EIRs) in April 2020. The site in Malaysia is set to produce insulin glargine biosimilar, and two sites in Bangalore, India are set to manufacture trastuzumab and pegfilgrastim oncology biosimilars.
India-based biologicals specialist Biocon (and partner) recently won a patent ligation for insulin glargine in the US and filed for the launch of the drug. Receipt of the Malaysian EIR paves the way for the launch approval and commercialization of this product in the US.
In India, FDA inspections in September 2019 raised eight observations which have now been given the all-clear. The inspection closures allow the company to file marketing authorization applications for its biosimilar products in several global markets.
As part of an ongoing collaboration, Biocon/Mylan announced on 9 March 2020 that FDA has accepted Mylan's Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab) [1], for review under the 351(k) pathway. This has potential to be Biocon/Mylan’s third oncology biosimilar in the US, which is currently available in India and other developing markets.
The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is 27 December 2020.
In early 2020, Biocon/Mylan launched pegfilgrastim biosimilar Fulphila in Australia [2] and Canada [3].
In 2019, Biocon/Mylan launched the first insulin glargine biosimilar in October [4] and first trastuzumab biosimilar in September in Australia [5].
The clearance of all three sites is set to boost the company's growth prospects in the US and in other key markets.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for Mylan’s bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 15].Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-Mylan-s-bevacizumab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Biocon Mylan launch pegfilgrastim biosimilar Fulphila in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 15].Available from: www.gabionline.net/Biosimilars/News/Biocon-Mylan-launch-pegfilgrastim-biosimilar-Fulphila-in-Australia
3. GaBI Online - Generics and Biosimilars Initiative. Pegfilgrastim biosimilar Fulphila launched in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 15].Available from: www.gabionline.net/Biosimilars/News/Pegfilgrastim-biosimilar-Fulphila-launched-in-Canada
4. GaBI Online - Generics and Biosimilars Initiative. Biocon Mylan launch first insulin glargine biosimilar in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 15].Available from: www.gabionline.net/Biosimilars/News/Biocon-Mylan-launch-first-insulin-glargine-biosimilar-in-Australia
5. GaBI Online - Generics and Biosimilars Initiative. Mylan launches first trastuzuma biosimilar in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 15].Available from: www.gabionline.net/Biosimilars/News/Mylan-launches-first-trastuzumab-biosimilar-in-Australia
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