Log in
Register|
M.Vasu ★ India, 2011-11-24 15:01 (4919 d 04:35 ago) Posting: # 7712 Views: 8,172 |
|
|
Hi, Can any one explain regarding BE study procedure for Biosimilars (Injection) in healthy subjets? Thanks, VM.......... Edit: Category changed. [Helmut] |
|
Helmut ★★★   Vienna, Austria, 2011-11-24 15:44 (4919 d 03:52 ago) @ M.Vasu Posting: # 7714 Views: 7,113 |
|
|
Dear VM, many countries have issued detailed guidelines already. The most comprehensive ones are EMA’s. See the Guidance page and scroll down to ○ Biotechnological and Biological Products, Biosimilars Although GLs consider cross-over studies the ‘Gold Standard’ in all (!) studies I have personally seen (and know of from other people as well) a significant sequence effect was observed. Maybe a parallel design is the better option. — 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 |
|
M.Vasu ★ India, 2011-11-28 13:33 (4915 d 06:03 ago) @ Helmut Posting: # 7740 Views: 6,971 |
|
|
Hi HS, Thanx for the reply, kindly explain me can i enroll healthy subjects for biosimilars BA/BE study ? Thanx in Advance!!!!!!!!!! VM |
|
Helmut ★★★ Vienna, Austria, 2011-11-28 13:56 (4915 d 05:41 ago) @ M.Vasu Posting: # 7741 Views: 7,032 |
|
|
Dear VM! ❝ […] kindly explain me can i enroll healthy subjects for biosimilars BA/BE study ? In the EU biosimilars are solely registered centrally at EMA. This process includes submission of protocols and generally scientific advisory meetings… You are aware that you need to perform phase III studies in the patient population to demonstrate safety/efficacy? When it comes to BE, healthy volunteers should be OK – providing safety/efficacy are not an issue. If possible include PD endpoints in the PK studies. See also the recent concept paper. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
|
drgunasakaran1 ★★  2012-02-06 14:57 (4845 d 04:39 ago) @ M.Vasu Posting: # 8059 Views: 6,435 |
|
|
❝ […] kindly explain me can i enroll healthy subjects for biosimilars BA/BE study ? Dear Mr.Vasu, You can enroll healthy volunteers in the Pharmacokinetic studies required for Biosimilars like Interferon alpha See section 5 Clinical Studies (Page 5 of 7). Efficacy and safety studies of Biosimilars will be done in patient population. Kindly go through EMA's Product Specific Biosimilar Guidances. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] — 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 |
|
Ben ★ 2011-12-16 20:04 (4896 d 23:32 ago) @ Helmut Posting: # 7784 Views: 6,726 |
|
|
Dear Helmut/all, you wrote ❝ Although GLs consider cross-over studies the ‘Gold Standard’ in all (!) studies I have personally seen (and know of from other people as well) a significant sequence effect was observed. Maybe a parallel design is the better option. Is there a specific reason why this is so? I mean, this sounds like the problem of having a sequence effect always occurs when having biosimilars. What is so "special" about them causing sequence (or carryover or trt*prd interaction) effects? Thanks, Ben |
|
Chiku ☆ India, 2012-02-03 07:43 (4848 d 11:53 ago) @ M.Vasu Posting: # 8043 Views: 6,478 |
|
|
Hi Vasu, As far as FDA is concerned i am not able to find specific guideline for biosimiler. But from my very little experience i can say: u will require to have 1) Sameness a) Bilogical sameness---PK/PD study either in Human or Animal model case by case basis b) analytical sameness by Size exclusion, Elisa etc suitable method for structure elucidation depends on molecule charecteristics 2) Bioequivalence with PK end point 3) Immunogenesity if applicable Regards Chiku:) |
|
drgunasakaran1 ★★ 2012-02-10 12:33 (4841 d 07:03 ago) @ Chiku Posting: # 8094 Views: 6,497 |
|
|
❝ As far as FDA is concerned i am not able to find specific guideline for biosimiler. Dear Mr.Chiku, The U.S. Food and Drug Administration issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product Biosimilars: Q & A - Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 — 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 |
|
Chiku ☆ India, 2012-02-10 13:03 (4841 d 06:34 ago) @ drgunasakaran1 Posting: # 8096 Views: 6,258 |
|
|
Dear Dr Gunasakaran, Thank you very much for information.. Regards, Chiku  |
|
Kumarnaidu2 ☆ India, 2021-10-22 09:53 (1299 d 10:43 ago) @ Chiku Posting: # 22653 Views: 3,119 |
|
|
Dear All, For a medicinal product to be administer as intravenous infusion (for approx. 3 hrs) if we consider Ctrough as one of the primary pk parameter for demonstrating PK similarity, does different rate of infusion amongst enrolled subjects has any impact on Ctrough levels? Thanks in advance, Kumar |
Ing. Helmut Schütz