#BIOLOGICS #BIOSIMILARS Awareness Series PART-2/n

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Generic Drug Vs #biosimilar
#Generic drugs for small molecules have a relatively simple chemical structure that can be reproduced or processed so that the chemical itself is identical.
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In #biosimilars it is not clear that any protein or peptide made, for example, in a different cell line or by a different company in a different process will be identical to the original biologic agent. There can be differences in the sugar residues or protein structure.
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Even if #biosimilar has same protein peptide chain, it may not have an identical effect. Thats why the process of making #biosimilars is not easy and can be fraught with problems. There are significantly more lot-to-lot variations.
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The developer of #biosimilar must have evidence that the pharmacodynamics and pharmacokinetics of the molecule are similar in patients, and they must have in vitro evidence that the molecule has the same mechanism of action. Otherwise it wont get approval.
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Benefit of using #biosimilar, none other than it is cheap as compared to #biologic
Same as #generic vs #originator drug
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KEY concern in #biosimilar consumption
some modifications might occur during the manufacturing process that will be undetectable and will lead to altered efficacy or toxicity
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Question: Are innovator companies also developing #biosimilars?
Answer: YES (Pfizer and Sandoz)
Because there is not much difference in pricing of a #biologic and #biosimilar
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US Court has allowed #biosimilar developers to do marketing of the product even before its FDA approval, so that their products can get to market quicker.
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