Dr_Dan ★★ Germany, 2015-02-17 19:55 (3349 d 13:50 ago) Posting: # 14445 Views: 3,046 |
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Dear all anybody familiar with biosimilars? If you have a small peptide (<50 aminoacids) and you can clearly show beside the aminoacid sequence that the chemical structure is exactly the same as in the originator drug do you need really more than a bioequivalence study to proof safety and efficacy? It is always told that the standard generic approach by demonstration of bioequivalence is in principle not sufficient to demonstrate similarity of biological/biotechnology-derived products due to their complexity. But hold this also true for a small peptide which is not complex like a therapeutic protein (>50 aminoacids)? Guideline CHMP/437/04 Rev 1 states that in specific circumstances, a confirmatory clinical trial may not be necessary. This requires that similar efficacy and safety can clearly be deduced from the similarity of physicochemical characteristics, biological activity/potency, and PK and/or PD profiles of the biosimilar and the reference product. However this sounds quite vague and I would like to know the prerequisites to follow the simple approach. Where can I find more Information? Of course it is a case by case decision but it would be helpful to know the pitfalls. Looking forward to your replies. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
ElMaestro ★★★ Denmark, 2015-02-17 20:40 (3349 d 13:05 ago) @ Dr_Dan Posting: # 14447 Views: 2,556 |
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Hi Dan, ❝ However this sounds quite vague and I would like to know the prerequisites to follow the simple approach. Where can I find more Information? Of course it is a case by case decision but it would be helpful to know the pitfalls. This is case-by-case and even between agencies the opinions differ. If I were you I would look into the original form of the peptide. If there is one form (only!) quantitatively, and if the copycat is exactly that same form quantitatively, then you will have some chance to convince the regulators of a true generic submission. You cannot find more info in the public domain, I think, and it is a little like the wind blows. So get scientific advice. And bring an apple. — Pass or fail! ElMaestro |
nobody nothing 2015-02-17 23:25 (3349 d 10:21 ago) @ ElMaestro Posting: # 14449 Views: 2,558 |
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Hi again! Any glycosides can be definitely excluded (via the expression system)? The impurity profile is dependent on the production process, so proteins are "a process", not "a compound". Usually. Ask the oracle, and don't be surprised about the answer... — Kindest regards, nobody |
VK ☆ Russia, 2015-02-19 18:07 (3347 d 15:38 ago) @ Dr_Dan Posting: # 14462 Views: 2,452 |
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Dear Dr_Dan, Very interesting question. ❝ However this sounds quite vague and I would like to know the prerequisites to follow the simple approach. Where can I find more Information? Of course it is a case by case decision but it would be helpful to know the pitfalls. Based on my experience in Russian Federation, the authorities are interested in manufacturing. So basically if both of the drugs, test and reference, are manufactured chemically (solid phase synthesis) , then the authorities might allow you to go for BE. Alternative if you use E.Coli or eukariotic systems, than you have to run clinical study. Sincerely, VK |