Gastroenterology

1. Compare Biologics &
Biosimilar
Dr Mayur Patel

2. Biologics:
• Biologics are pharmaceutical compounds synthesised or extracted
from a biological source often with highly complex structures.
• Manufacturing processes involve living systems( e.g mammalian cell
lines, microbial agents, plants, fungus) & complex process ( gene
isolation, r DNA engineering, protein purifications).
• Biologics agents have potential to alter behaviour of cytokines,
cellular activations & inflammatory gene transcription.

3. • Biologics approved by FDA for treatment of IBD:
1. Anti TNF agents
2. Anti – Integrin agents: Natalizumab , vedolizumab
Infliximab
Adalimumab
Golimumab
Certolizumab

4. Biosimilars:
• Biologics are too complicated & large molecules to make it into
generic version.
• Biosimilars should have following charecteristics
1. should be biologic product
2. reference product should be an already licensed biologic product
3. demostrate high similarity in safety, quality & efficacy.
• Biologics medications that the biosimilar is based on is called
Reference product(RP)

6. • Biosimilars are cost effective
• Improved drug access.
• Require two phase clinical
trial for approval
→ Phase I- to demonstrate
equivalence in PK,PD & safety.
→ Phase III to demonstrate no
clinically meaningful differences
with respect to efficacy, safety
& immunogenicity

11. • evaluate the effect of AZA or infliximab monotherapy compared
with combination therapy in patients
without prior exposure to these agents, the Study of Biologic
and Immunomodulator Naïve Patients with Crohn’s Disease
(SONIC) study was performed.
• In ACT-I trial for UC, short term response of infliximab vs placebo
group was 65% & 33% respectively & long term response at 54 weeks
53% & 24% respectively.
Infliximab alone Azathioprine alone Infliximab +
azathioprine
combination
Clinical remission at
6 months of
treatment
44% 30% 57%

12. Adverse reaction:
• Infliximab infusion reaction occurred in 4-16% of patients while in CT-
P13 treated patients infusion reactions occurred in 6.7% of patients.