Biosimilars are rapidly replacing Biologics in Ocular Therapeutics because of their affordability and wide applications.

1. BIOSIMILARS: A NEW APPROACH IN
OCULAR THERAPEUTICS
DEEPTI M SATI

2. OCULAR THERAPEUTICS
 Eye is a complex system in itself
 Challenging for the Pharmacologist and Ophtholmologists
 Aims at maximum bioavailability of drug with minimum
toxicity to other tissues

3. OCULAR DISEASES
 Keratitis
 Conjunctivitis
 Retinoblastoma
 AMD
 Cataract
 Galucoma
 Diabetic retinopathy

4. BIOLOGICS

5. LONG JOURNEYOF OCULAR
THERAPEUTICS
 Eye drops, ointments
 NDDS
 Biologics

6. BIOLOGICS……???
 Journey of ocular therapeutics started from eye drop to
NODDS now included Biologics
 Complex Macromolecules made of Sugars, aminoacids
 Vaccines, blood components or may be living entitities
cells tissues all are biologics

7. CONS OF BIOLOGICS
 High Cost Involved
 Long Time in development
 Longer Clinical Trials

8. What
Next:BIOSIMILAR…….??
 A biosimilar is a biological product that is highly similar to
and has no clinically meaningful differences from an
existing FDA-approved reference product..

9. REFERENCE PRODUCT
 A reference product is the single biological product, already
approved by FDA, against which a proposed biosimilar
product is compared. A reference product is approved
based on, among other things, a full complement of safety
and effectiveness data.

10. PROS
 Prove similarity in pharmacokinetics
pharmacodynamics,immunogenecity safety & efficacy
 Cost involved vs profit
 Cost & time involved is less

11. CONS
 Living cells :No Fixed chemical formula
 No complete information in terms of manufacturing.
 It makes the development of biosimilars difficult

12. POTENTIAL BIOSIMILARS
 Razumab Biosimilar of Ranizumab (Intas
Pharm)
 Approved for use in Wet AMD ,RVO,DME etc
& CNV
 Adalimumab (Humira) (Abott) Non infectious
uveitis.

13. FUTURE PROSPECTIVES
 Discounts of 15%-30% compared to the reference product
in U.S while in Europe there have been examples of 30%-
40% cuts.
 India being a developing country is being a great hub for
biosimilars because of its affordability.
 Biosimilars have bright future expectations globally.