The clinical portion I believe is ready to go if t
Post# of 154840
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Posted On: 06/20/2019 5:00:59 PM
The clinical portion I believe is ready to go if the FDA accepts 525mg for combo. If the FDA still wants 700mg, they will need 24 weeks of safety data, which I believe would be done sometime in August.
For the CMO portion, I'm not sure what all needs to be done, but NP said that would take a couple months. I guess they need to add Samsung data, so it might take some time to get the studies due at the time of BLA submission; it must be already being created and ready for inspection when the BLA is submitted.
Samsung has top notch facilities was approved in the last couple of years by the FDA for mabs and they have had several approvals this year for biosimilars. So that is just a matter of doing the work needed for the BLA and inspections.
2017
https://www.biopharma-reporter.com/Article/20...000L-plant
The world’s largest single bioproduction plant has received its first US regulatory approval to make a monoclonal antibody, says CDMO Samsung Biologics.
2018
https://www.prnewswire.com/news-releases/sams...54138.html
Samsung BioLogics announced license-approval by the US FDA to create a mAb drug product at its Plant 1 facility.
https://www.fiercepharma.com/manufacturing/sa...rean-plant
Samsung BioLogics reaches milestone with FDA nod for production of mAb at South Korean plant
https://www2.ispe.org/imis/conference-handout...oducts.pdf
https://www.fda.gov/media/71021/download
For the CMO portion, I'm not sure what all needs to be done, but NP said that would take a couple months. I guess they need to add Samsung data, so it might take some time to get the studies due at the time of BLA submission; it must be already being created and ready for inspection when the BLA is submitted.
Samsung has top notch facilities was approved in the last couple of years by the FDA for mabs and they have had several approvals this year for biosimilars. So that is just a matter of doing the work needed for the BLA and inspections.
2017
https://www.biopharma-reporter.com/Article/20...000L-plant
The world’s largest single bioproduction plant has received its first US regulatory approval to make a monoclonal antibody, says CDMO Samsung Biologics.
2018
https://www.prnewswire.com/news-releases/sams...54138.html
Samsung BioLogics announced license-approval by the US FDA to create a mAb drug product at its Plant 1 facility.
https://www.fiercepharma.com/manufacturing/sa...rean-plant
Samsung BioLogics reaches milestone with FDA nod for production of mAb at South Korean plant
https://www2.ispe.org/imis/conference-handout...oducts.pdf
https://www.fda.gov/media/71021/download
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