Biosimilars

dave_1

Will they be detected in 2009? Am confused as Damsgard suggests biosimilars are a loophole from my reading...yet JV of Garmin suggests his team is preventing this. See the interview comments by JV re biosimilars on http://www.cyclingnews.com/features.php ... osed_dec08


Also
http://www.steroidreport.com/2008/07/21 ... po-agents/

http://www.biogenericspipeline.com/biogenerics/

iainf72

No need to be confused.

What JV and his merry men are doing is looking for the effects of EPO or biosimilars. They don't need to detect the substance, just its effect.

That's what the passport does as well and also what Damsgaard does. However you would not find evidence of the drug itself with "normal" tests.

dave_1

iainf72 wrote:

No need to be confused.

What JV and his merry men are doing is looking for the effects of EPO or biosimilars. They don't need to detect the substance, just its effect.

That's what the passport does as well and also what Damsgaard does. However you would not find evidence of the drug itself with "normal" tests.

Ok, but the blood parameters of a rider on Cera look pretty normal unlike previous generation EPO-or at least that what it says on the box- so was wondering if other EPO biosimilars being produced do as CERA but can't be tested for?

OffTheBackAdam

Biosimilars are essentially generic copies of EPO, eg EPO-Alpha not produced by Amgen (It's original synthesiser)
Blood parameters for anyone on CERA would look just the same as those of any other form of EPO.
All these agents do, is boost red blood cell (RBC) production, so leads to an increase in haematocrit (Hct), the % of cellular matter in blood.
Since Hct, in healthy individuals, is virtually entirely RBC, an increase in Hct means an increase in RBCs.
The problem is, and has been, to detect an artificial increase in Hct.
A test for EPO-Alpha, Beta or Delta, won't detect CERA, or autologous or homologous blood transfussions for instance.
The problem for those trying to detect when an athlete has used CERA, is that it can be taken weeks prior to competition and its effects still be felt, long after it has been excreted from the body.

sward29

The use of synthetic EPO alfa, beta, Aranesp or CERA can be detected in urine through the use of electropheresis as they all produce a different profile compared to naturally produced endogenous EPO. The only problem may be with EPO Delta (Dynepo) as it is produced from a human cell line, rather than hamster cell line, so may not be differently charged compared to endogenous EPO. Dynepo has been detected in Rasmussen's urine but I'm not sure how they did this.

Re biosimilars, all the other biosimilars are produced through the hamster cell line tand therefore should be as easy to detect (!) as established brands.

dave_1

sward29 wrote:

The use of synthetic EPO alfa, beta, Aranesp or CERA can be detected in urine through the use of electropheresis as they all produce a different profile compared to naturally produced endogenous EPO. The only problem may be with EPO Delta (Dynepo) as it is produced from a human cell line, rather than hamster cell line, so may not be differently charged compared to endogenous EPO. Dynepo has been detected in Rasmussen's urine but I'm not sure how they did this.

Re biosimilars, all the other biosimilars are produced through the hamster cell line tand therefore should be as easy to detect (!) as established brands.

thanks for the info...so it would seem there really is a very limited chance of riders trying blood doping between the passport and the fact biosimilars are detectable. It seems that genetic doping is the only thing to be worried about in terms of large scale doping?

aurelio_-_banned

Dave_1 wrote:

It seems that genetic doping is the only thing to be worried about in terms of large scale doping?

I would say that carefully managed autologous blood doping is still a major issue.

OffTheBackAdam

Shire Pharmaceuticals has discontinued Dynepo in Europe, they can't compete pricewise against the existing EPO variants.