What is meant by biosimilars?
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What is meant by biosimilars?
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company.
What makes a biosimilar?
A biosimilar is made from a biologic (natural) source, and a generic is made from chemicals. A biosimilar comes from the same natural source and is the same in certain ways as its brand name biologic drug, while a generic is an exact chemical copy of its brand name drug.
What is biosimilar in pharmacy?
A biosimilar product is a biologic product that is approved based on demonstrating that it is highly similar to an FDA‐approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.
What is the difference between a generic and a biosimilar?
Biosimilar drugs are often confused with generic drugs. Another key difference is that generics are copies of synthetic drugs, while biosimilars are modeled after drugs that use living organisms as important ingredients.
What are biosimilars examples?
FDA-Approved Biosimilar Products
| Biosimilar Name | Approval Date | Reference Product |
|---|---|---|
| Abrilada (adalimumab-afzb) | November 2019 | Humira (adalimumab) |
| Ziextenzo (pegfilgrastim-bmez) | November 2019 | Neulasta (pegfilgrastim) |
| Hadlima (adalimumab-bwwd) | July 2019 | Humira (adalimumab) |
| Ruxience (rituximab-pvvr) | July 2019 | Rituxan (rituximab) |
Why do we need biosimilars?
Biosimilars are important because they have an opportunity to provide competition in the market and expand patient access to critical medicines, much like the advent of generic medications more than 35 years ago. We live in an era of biologic medicine.
What is the difference between a biologic and a biosimilar?
Biologic drugs are large, complex proteins made from living cells through highly complex manufacturing processes. Unlike generic drugs, which are copies of chemical drugs, a biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original medicine.
Why are biosimilars different?
As biologic medicines, biosimilars are inherently different from generics due to their molecular size and structure, and the complexity and cost of their development. Biosimilars also have significantly higher research and development costs and risks and are more complex to manufacture than small-molecule generics.
Are biosimilar drugs interchangeable?
To be approved as interchangeable, research must show that the biosimilar drug produces the exact same results in an individual patient—meaning that a person can take either drug and expect the same symptom reduction and same side effects. To date, no biosimilars have been approved as interchangeable.
How are biosimilars approved?
The FDA approves a biosimilar after a manufacturer establishes that the product is highly similar to a previously approved originator biologic reference product without any clinically meaningful differences in safety, purity, and potency.