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Anaemia
Use
c eps Eprex
Prin Cause Pure Red
EPO Cell Aplasia
(PRCA)
Princeps
Data exclusivity: biosimilar can only le its MA application
(MAA) after a period of 8 years following the initial MA of the
princeps in the Community and cannot be sold before a
period of 10 years as from that same MA
assess any alterations in reactivity
In vitro between the similar biologic and
the reference
Preclinical
to quantitatively compare the
In vivo erythrogenic effects of the similar
biologic and the reference
EPO specific PK-selected dose should be in the sensitive
requirement PK & PD
part of the dose-response curve. PD-
selected dose should be in the linear
ascending part of the dose-response curve
patient must be
doctor choose the
Effective problems of informed
product that with full
pharmacovigilnce immunogenicity characteristics
knowledge
product administered
India : Similar Biologics Guidelines and
Implementation
There are more than 40 biologics approved and marketed
in India, of which 20 are biosimilars
A biosimilar a biological product produced by genetic
engineering techniques and is claimed to have similar
properties and effects as a reference biological product.
Safety
Similar
Biologic Quality
product
Efficacy
Biosimilar Product in India
Molecul Downstream Quality based
Characterization
Considerations Processing Considerations
Extrapolation of
Pharmacokinetic and Efficacy and Safety
Pharmacodynimic Data to other
Indications
Molecular biology Downstream
Manufacturing
considerations processing
the details of the the vectors, cell the process of
process must be lines, gene manufacturing
clear, which sequences and the biosimilar
includes cell other details must be
cultures, regarding the reproducible,
harvesting production of the and the relevant
techniques, similar must be data of the
purification, etc described. processes
It must be involved must
according to be submitted.
GMP and it must
give consistent
results.
Characterisation which should explain the
physicochemical and biological characteristics of the
product, and should include samples of it as well as
statistical data.
Quality-based considerations comparing the biosimilar
with the reference product and seeing if there are even
slight differences in the qualities between the two.
Pre-clinical studies which includes in vitro and studies
using animal models to test the biosimilar.
to test the safety and efficacy only if the similarity to the
of the biosimilar in humans. reference product has been
scientifically proven and the
mechanism of action for the
other indication is the same.
pharmacokinetic
and Extrapolation to
pharmacodyna other indications
mic
Post-marketing Immunogenicity
data data