BIOSIMILARS

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BIOSIMILARS A NEW APPROACH IN OCULAR THERAPEUTICS

• DEEPTI M SATI

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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

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OCULAR DISEASES

• Keratitis
• Conjunctivitis
• Retinoblastoma
• AMD
• Cataract
• Galucoma
• Diabetic retinopathy

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BIOLOGICS
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LONG JOURNEYOF OCULAR THERAPEUTICS

• Eye drops, ointments
• NDDS
• Biologics

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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

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CONS OF BIOLOGICS

• High Cost Involved
• Long Time in development
• Longer Clinical Trials

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What NextBIOSIMILAR.??

• A biosimilar is a biological product that is
  highly similar to and has no clinically
  meaningful differences from an existing
  FDA-approved reference product..

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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.

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PROS

• Prove similarity in pharmacokinetics
  pharmacodynamics,immunogenecity safety efficacy
• Cost involved vs profit
• Cost time involved is less

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CONS

• Living cells No Fixed chemical formula
• No complete information in terms of
  manufacturing.
• It makes the development of biosimilars difficult

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POTENTIAL BIOSIMILARS

• Razumab Biosimilar of Ranizumab (Intas
• Pharm)
• Approved for use in Wet AMD ,RVO,DME etc
• CNV
• Adalimumab (Humira) (Abott) Non infectious
• uveitis.

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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.

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THANKS ..