A biosimilar is a biological product that is approved based on the evidence demonstrating that it is highly similar to an approved biological product (original) in terms of structure, function, quality, and clinical efficacy and safety. Biosimilars are developed such that there are “no clinically meaningful differences between the biological product and the original (reference) product in terms of safety, purity, and efficacy”. (19)
Terminology | Definition |
---|---|
Biosimilars | Biosimilars are biological products that are highly similar to approved biological products in terms of structure, function, quality, clinical efficacy and safety. |
Biologic | A therapeutic antibody, vaccine, virus, blood product or protein used for treatment in patients. |
Generics | A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality and performance characteristics. |
Reference product | The single FDA-approved biologic product against which a biosimilar is evaluated. |
(19, 20, 21)
Biosimilars | Generics | |
Definition |
Biosimilars are biological products that are highly similar to approved biological products (original) in terms of structure, function, quality, and clinical efficacy and safety.
|
A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality and performance characteristics. Essentially, generics are copies of synthetic drugs. |
Example |
Herzuma® is a biosimilar brand of Herceptin®. Both contain trastuzumab as the active ingredients. |
Uphamol® is a generic brand of Panadol®. Both contain paracetamol, also known as acetaminophen as the active ingredients. |
Manufacturing |
Biosimilars are made from living sources. Biosimilars are not exact copies but they are highly similar to original product. There are no clinically meaningful differences between the biosimilars and the original products in terms of safety, purity, and efficacy. |
Generics are made from chemical processes. Generics are identical to original products.
|
Production |
Processes are very complex, difficult to reproduce |
Relatively easy to produce |
Structure of Drugs |
Biosimilar is highly similar to the original (reference) product. They have same protein sequence but may differ in part of the 3D structure. The difference will not affect the drug efficacy, safety and risk. |
The generic drug and the original brand medication are structurally identical.
|
(19, 21, 22)
Last Update: 08/09/2021