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cakhatri ★ India, 2014-03-02 15:25 (4496 d 21:25 ago) Posting: # 12544 Views: 7,094 |
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Dear Members, We have a requirement on conduct of study on Glatiramer acetate injection (20mg) for USFDA submission. The study is to be conducted in India. There are no FDA guidelines on conduct of the study for ANDA submission.Can anyone share their experience in conducting study with this molecule Regards Chirag |
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Dr_Dan ★★ Germany, 2014-03-03 13:23 (4495 d 23:26 ago) @ cakhatri Posting: # 12551 Views: 5,705 |
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Dear Chirag I do not understand why you have to conduct a BE study since your formulation is a solution for subcutaneous injection. The only excipient of the RLD is mannitol and if you do not use a different excipient there should be no formulation effect and consequently a BE study is not necessary. Please explain. Thanks in advance. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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nobody nothing 2014-03-03 14:06 (4495 d 22:44 ago) @ cakhatri Posting: # 12552 Views: 5,659 |
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Should be a candidate for biosimilar pathway... http://www.gabionline.net/Pharma-News/FDA-rejects-second-citizen-petition-for-Teva-s-glatiramer-acetate-drug Regards — Kindest regards, nobody |
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drgunasakaran1 ★★  2014-03-06 18:26 (4492 d 18:24 ago) @ cakhatri Posting: # 12570 Views: 5,575 |
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Dear Mr Chirag, In his response to Teva's second citizen petition, FDA asserted its ‘broad discretion’ in determining whether the submitted information (conventional bioequivalence study) is enough to conclude that the generic product is the same as the original. The agency also stated that it may require a generic company to prove sameness "although we cannot state with any certainty what these criteria may be. A finding of sameness does not, however, necessitate a finding of ‘complete chemical identity’. Thus, the agency may consider other criteria to determine sameness, taking into account the complexity of the active ingredient. Hence, you can conduct bioequivalence study for ANDA, however, it is upto FDA to give final nod on the approval of bioequivalence study. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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nobody nothing 2014-03-07 12:48 (4492 d 00:01 ago) (edited on 2014-03-07 14:26) @ drgunasakaran1 Posting: # 12573 Views: 5,584 |
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❝ ..The agency also stated that it may require a generic company to prove sameness "although we cannot state with any certainty what these criteria may be. A finding of sameness does not, however, necessitate a finding of ‘complete chemical identity’. Thus, the agency may consider other criteria to determine sameness, taking into account the complexity of the active ingredient. Decision by the FDA might be available as early as May 2014. Good luck with BE-study (and some good lawyers, too, maybe?)  Regards btw: Strange that for a chemically undefined compound with parenteral application mode a BE study should provide meaningful data to support therapeutic equivalence for an ANDA... — Kindest regards, nobody |
Ing. Helmut Schütz