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I am starting my second week of Epogen usage for possible kidney failure and definite anemia. I can not say for sure but it seems to me that he medication does its job. I feel better and I hope the tests I have undergone this evening will show an improvement. My blood pressure is much better now and I think it is all due to Epogen.

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Every biological displays a certain degree of variability (microheterogeneity), even between different batches of the same product, which is caused by the inherent variability of the biological expression system and the manufacturing process.

To support approval of an extrapolated indication, a biosimilar sponsor may need to demonstrate that the biosimilar has the same mechanism of action, target-binding characteristics, pharmacokinetics, and biodistribution in the clinically tested and the extrapolated indications, as well as address any expected differences in toxicity or effectiveness.

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