Tugas Biosimilar

Maria Euphrasia Yolanda 148114161

Leona Wong 148114162
Melviya 148114163
Nur Amalia Perwitasari 148114167
Diana Putri Kartika Sari 148114171
Fransiska Indri Sagala 148114179
Biosimilar EPO: The reasons to
be condent
Biological
Safety Immunogenicity?
products

Anaemia
Use

c eps Eprex
Prin Cause Pure Red
EPO Cell Aplasia
(PRCA)

Biosimilar Safety, efficacy, quality?

 Patent law: grants 20-year monopoly of use from the ling
date, can be extended to give additional of max 5 years

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

Comparable clinical efcacy between

similar and reference should be
Clinical Clinical Efficacy demonstrated in at least two adequately
powered, randomised, parallel group clinical
trials in patients with renal anaemia.

The EPO guideline mentions that the

applicant should provide at least 12-month
Clinical safety
comparative immunogenicity data pre-
authorisation.
 the EPO guideline mentions that the demonstration of
extrapolation of efcacy and safety in renal anaemia may allow extrapolation
indications
to other indications of the reference medicinal product if
appropriately justied by the applicant.

We suggest extrapolation shouldnt be applied in biosimilars

product because it couldnt ensure that all indications share
the same mechanism
 PLACING A BIOSIMILAR ON THE MARKET: SELLING UNDER HIGH
SURVEILLANCE

Safe prescription by the

Appropriate monitoring doctor and delivery to the
patient

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

Safety and Post Market Pre-Clinical

Manufacturing
Immunogenicity Data Study
Process
Data

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
of the biosimilar in humans.
only if the similarity to the
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

pharmacovigilance, to ensure to see if the product can cause

the safety of the consumers severe allergic reactions.
after the biosimilar has been
released into the market.
 Indian similar biologics guidelines provide regulatory
requirements for evaluation of applications for marketing
authorization of biological products that claim to be similar
to already approved biopharmaceutical products, referred
to by the Indian authorities as similar biologics.
Development and implementation of Indian similar
biologics regulatory guidelines for approval of market
authorization was a path-breaking development to bring
clarity on the subject and lay out a clear regulatory
pathway for manufacturers of similar biologics.
THANK YOU