BIOSIMILAR AND FOLLOW-ON BIOLOGICS
Biosimilar products are expected to be comparable to an approved
reference product in terms of quality, safety and efficacy profile. Approval of
these products should be considered based on product comparisons and
demonstration of comparability to the reference product.
Biopharmaceutical products may be currently manufactured by the same
manufacturer at different sites. The “FDA Guidance on comparability” protocol
is used for assuring product quality of the approved product after certain
changes are made in the manufacturing process (comparability assessment, see
below). The quality of these products is assured by chemical analysis and/or by
using a comparability clinical study protocol.
A question often raised and debated by a generic manufacturer is whether
the approach of using a comparability protocol can be extrapolated and adopted
for approval of biosimilar products manu-factured by a different manufacturer.
The regulatory answer today is no, it cannot be used for the approval of a
biosimilar product.
The requirements for approval of biosimilar products should be based on
the structural complex-ity and clinical knowledge of and experience with the
reference biopharmaceutical product. Products such as growth hormone and
interferon, for example, have known and relatively simple chemical structures.
In addition, extensive manufacturing and clinical ex-perience is available for
these products. On the other hand, monoclonal antibodies are large,
glycosylated proteins and clinically less experience has been obtained with
them so far. Because of the varying complexity of the biotech-derived products,
the requirements for the approval process should be structured on a
case-by-case basis. The following information is required for product approval.
·
Structural information—Primary,
secondary, ter-tiary, and if relevant, quaternary structure infor-mation,
including information regarding the
·
glycosylation pattern, if
relevant. n Manufacturing process
·
Quality attributes and clinical
activities
·
Pharmacokinetic-Pharmacodynamic
information, mechanism of drug action
·
Clinical experience, efficacy and
toxicity infor-mation
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