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Shuanghe ★★ Spain, 2011-03-18 12:59 (5581 d 22:57 ago) Posting: # 6772 Views: 4,293 |
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Hi all, Being a long time reader but this is my first post. So Helmut, just to let you know I did read Forum Policy first and did a search before posting.  So here it goes. There's this chemical, reference product (X) is modified release formulation (pellets in capsule) with 2 strength, say, A1 and A2. We did 2 BE studies with the higher strength and everything's OK and we should be able to obtain MA for generic of this reference. The trick is that this chemical also has another brand name (Y, from same innovator) with different indication and different strength, say B1 and B2. also modified release pellets in capsule. Now the question is that if we can market our generic product for reference Y without doing additional BE study. The idea is to persent dossier with strength B1 and B2 requesting MA of generic for reference Y, but quoting the data from BE studies of strength A1 (the highest of the 4 strengths). PK is linear by the way. My personal impression is that we might have to repeat 2 BE studies with Y as reference since the indication is changed but I'm not sure  . My colleague from business dpt want no BE at all (understandably though).Can anyone point some web/reference/guideline to me to look in detail? And any opinion/suggestion is welcome. Thanks. Shuanghe — All the best, Shuanghe |
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Jaime_R ★★ Barcelona, 2011-03-18 13:59 (5581 d 21:57 ago) @ Shuanghe Posting: # 6773 Views: 3,675 |
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Hi Shuanghe! ❝ [...] I did read Forum Policy first and did a search before posting. Much appreciated!  I would say, you are right - and the business guy wrong. Leaving the issue of different strengths and linear PK aside, tell the business guy how the concept of a generic authorization works:
— Regards, Jaime |
), except pre-clinical (tox, ...) and clinical (PK, safety/efficacy) data. The exemption is based upon the main assumption of bioequivalence that similar concentrations will lead to similar effects. If the innovator has two brands with different indications on the market, there will be also different clinical studies in the back.|
Shuanghe ★★ Spain, 2011-03-18 17:04 (5581 d 18:51 ago) @ Jaime_R Posting: # 6776 Views: 3,686 |
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Thanks Jaime! ❝ I would say, you are right - and the business guy wrong. yeah...  But I need hard evidence to convince them. It would be wonderful if there's guideline or some regulation rules to follow. I couldn't find anything useful in EMA website but that may just due to my lack of knowledge in regulatory process. Usually I'd  but this time, well, embarrassingly, I don't even have a clue which key words to use.  Any further help? Shuanghe — All the best, Shuanghe |
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Helmut ★★★   Vienna, Austria, 2011-03-18 22:25 (5581 d 13:31 ago) @ Shuanghe Posting: # 6777 Views: 3,659 |
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Dear Shuanghe, welcome to the forum! ❝ It would be wonderful if there's guideline or some regulation rules to ❝ follow. Easy. The BE-GL in Section 2.1 leads to Directive 2001/83/EC. Article 10 2(b) defines a generic product, but see the next paragraph: 3. In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided. (my emphasis)— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Shuanghe ★★ Spain, 2011-03-21 11:10 (5579 d 00:46 ago) @ Helmut Posting: # 6781 Views: 3,618 |
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❝ welcome to the forum! though never posted anything. After reading the reference article you pointed out now I'm confused. Maybe I didn't state my question clearly enough in previous post. Firstly, let's drop irrelevant part and rephrase paragraph you cited as: In case of changes in therapeutic indications or strength in comparison with reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided. Now, just a bit clarification for my previous post. Since our 2 BE studies are ok for me our generic project for this compound is finished using the reference prodcut X with indication stated in its SPC (assuming everything else's fine. God knows, by experience there might be something else goes terribly wrong but that's not my concern at the moment.  ). Now Business Dpt propose to have another project, using same chemical, well, same test formulation since generic formulation is already developed (main reason they propose the idea I guess, to avoid additional development cost), but against reference Y with its new indication (and with diffferent strength). In this case, there would be no change of indication since the aim is to claim whatever new indication this Y is claiming. My gut tells me it's still a no-go but the evidence mentioned above seem not, how to put it, hit the target?. Or I misunderstood your point? — All the best, Shuanghe |
Ing. Helmut Schütz