What if the suplier excipients don't match my formulation?I mean they make their own "solution" or liophilized product. Do I just ignore this and make my own formulation or do I need to base my formulation to theirs?
Hi José, biosimilars are usually drugs with expired patents. Their formulation is usually fair game. If you have any doubts, consult the FDA website to see which additives are approved for human use.
If you change any of the ingredients you must submit a new NDA (new drug application) or biological equivalent. This means including clinical studies ($$$) which is the reason the make an expired biosimilar. Are you surprised you found a 'landmine' planted by the originator and designed to scuttle any generic manufacturing? Common!
make your formulation, but the quantity of inactive ingredients should be safe, you can follow the link
http://www.accessdata.fda.gov/scripts/cder/iig/index.Cfm
Thank you for your anwsers, the thing is that we make our own API so there aren't supposed to be any "landmines", I know well the additives where the API is preserved but the formulation for a liophilized and a solution is different, that's my problem.
Then the process is different, but is it different than the originator? If your answer is yes then it's an NDA, but you can use some of the original clinical studies (like the drug's/API effectiveness).
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