M.Vasu
★    

India,
2011-11-24 15:01
(4087 d 04:23 ago)

Posting: # 7712
Views: 5,596
 

 Biosimilars [Design Issues]

Hi,

Can any one explain regarding BE study procedure for Biosimilars (Injection) in healthy subjets?

Thanks,

VM..........


Edit: Category changed. [Helmut]
Helmut
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Vienna, Austria,
2011-11-24 15:44
(4087 d 03:40 ago)

@ M.Vasu
Posting: # 7714
Views: 5,024
 

 Biosimilars

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.

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M.Vasu
★    

India,
2011-11-28 13:33
(4083 d 05:52 ago)

@ Helmut
Posting: # 7740
Views: 4,883
 

 Biosimilars

Hi HS,

Thanx for the reply, kindly explain me can i enroll healthy subjects for biosimilars BA/BE study ?

Thanx in Advance!!!!!!!!!!

VM
Helmut
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Vienna, Austria,
2011-11-28 13:56
(4083 d 05:29 ago)

@ M.Vasu
Posting: # 7741
Views: 4,920
 

 Healthy subjects vs. patients

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.

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drgunasakaran1
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2012-02-06 14:57
(4013 d 04:28 ago)

@ M.Vasu
Posting: # 8059
Views: 4,329
 

 Biosimilars

❝ […] 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 S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Ben
★    

2011-12-16 20:04
(4064 d 23:21 ago)

@ Helmut
Posting: # 7784
Views: 4,558
 

 Biosimilars

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
(4016 d 11:41 ago)

@ M.Vasu
Posting: # 8043
Views: 4,353
 

 Biosimilars

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
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2012-02-10 12:33
(4009 d 06:51 ago)

@ Chiku
Posting: # 8094
Views: 4,372
 

 Biosimilars

❝ 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 S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Chiku
☆    

India,
2012-02-10 13:03
(4009 d 06:22 ago)

@ drgunasakaran1
Posting: # 8096
Views: 4,172
 

 Biosimilars

Dear Dr Gunasakaran,

Thank you very much for information..

Regards,

Chiku :-)
Kumarnaidu2
☆    

India,
2021-10-22 09:53
(467 d 10:32 ago)

@ Chiku
Posting: # 22653
Views: 974
 

 Biosimilars

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
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