Generic biologicals

1. Generic biologicals
SUBMITTED BY- PREHLAD
ROLL NO.-220121220013
Submitted To- Dr. D.C Bhatt

2. Contents
• Generic biologics
• Biosimilar drug products
• Generic substitution
• Special concerns in bioavailability and bioequivalence studies

3. • Generic-
A generic drug is a pharmaceutical drug that contains the same chemical
substance as drug that was originally protected by chemical patents.
• Biologics -
A therapeutic agent manufactured in a living system such as a
microorganism , plant or animal cell using recombinant DNA
technology.
• Biological products-
Biological products are a diverse category of products and
are generally large, complex molecules.
• These products may be produced through biotechnology in a living system, such as a
microorganism, plant cell, or animal cell.
• And that are often more difficult to characterize than small molecules drugs.

5. • Biosimilar - A biosimilar drug that is very much like another biological drug
(called the reference drug) that has already been approved by the U.S. Food and
Drug Administration (FDA) and has no clinically meaningful differences in
terms of safety and effectiveness from the reference product.
• A biosimilar drug is a safe and effective, high-quality treatment that is "highly
similar with no meaningful clinical differences" to a brand name biologic drug
that's used to treat a certain disease.
• Almost identical copy of an original biological product.
• They are large molecules with complex structures.
• They are prepared from engineered organisms
• e.g.: Insulin produced from E-Coli.

6. Biosimilars Include
• Blood and Plasma products
• Non recombinant products
• Recombinant products
• Monoclonal antibodies
• Vaccines

7. Requirements for Biosimilars
• It should be biologic product.
• Reference product should be an already licensed biologic product.
• The biosimilar should demonstrate a high similarity of safety, quality and efficacy to that
of the reference product.
• Similarity should be determined by comparing the biosimilar product with the reference
product based on quality, non clinical and clinical studies.

8. GENERIC SUBSTITUTION
• Generic substitution is the term applied to the substitution of a prescribed branded drug
by a different form of the same active substance. The generic is usually unbranded
• Brand name : zovirax®
Generic name : acyclovir
• However, therapeutic classes such as hormones and drugs with narrow therapeutic index
(anticonvulsants, anticoagulants ,etc.) may not be appropriate for generic substitution
because this drug cause serious toxicity or therapeutic failure when minor change occur
in dose size during manufacturing process.

9. SPECIAL CONCERNS IN BIOAVAILABILITYAND
BIOEQUIVALENCE STUDIES
• For certain drugs and dosage forms , systemic bioavailability and bioequivalence are different
to ascertain for e.g. Cyclosporine, verapamil are considered to be highly variable.
• The number of subjects required to demonstrate bioequivalence for these drug products may
be excessive , requiring more than 60 subjects.
• The intrasubject variability may be due to the drug itself or to the drug formulation or to both.
• The FDA has held public forums to determine whether the current bioequivalence guidelines
need to be changed for these highly variable drugs.