What is a biosimilar biologic?
A biosimilar is a biologic that is highly similar to, and has no clinically meaningful differences from, another biologic that’s already FDA-approved (referred to as the reference product or original biologic). This means biosimilars: Are given the same way (same route of administration).
What is the purpose of biosimilars?
The primary purpose of biosimilars is to reduce the healthcare costs associated with the use of biologics and thereby increase access to healthcare. Unlike small molecule generics, the bioequivalence approach is not considered appropriate for the approval of biosimilars.
What is the difference between biosimilar and generic?
Generic drugs are chemically identical to the original branded drug and, as such, cost significantly less because they don’t require much testing. Because biosimilars are made from living organisms, though, and don’t contain identical ingredients to their name-brand counterparts, they still require some testing.
What is a biosimilar pathway?
The abbreviated pathway permits the biosimilar applicant to rely on the safety and effectiveness of the approved product, enabling a biosimilar product to gain FDA approval based on less than a full complement of preclinical and clinical data.
How do biologics work?
Biologics work by interrupting immune system signals involved in the inflammatory process that result in damage to joint tissue. The first type of biologic approved for use in treating RA was designed to target the protein called TNF.
How are biosimilars regulated?
FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety (and effectiveness of the biosimilar or interchangeable product, just as they would the reference product.
What is an example of a biologic?
Some examples of biologics include hormones, blood products, cytokines, growth factors, vaccines, gene and cellular therapies, fusion proteins, insulin, interferon, and monoclonal antibody (mAb) products. Patients receive biologics mainly by injection under the skin (subcutaneously) or by intravenous infusion.
What is the process to make biosimilars?
Biosimilar development process The chosen cell line is expanded in large bioreactors, in conditions optimized for protein production. The harvested protein is analyzed for uniformity in its 3D structure and potency before being purified. The synthesised biologic is isolated and purified, removing any unwanted …
How are biosimilars made?
Biosimilars are produced by recombinant DNA technology in living organisms as opposed to the chemical synthesis required for generics [1]. Manufacturing of biosimilars is more challenging than the traditional small molecule generics mainly due to biosimilars being larger and more complex molecules.
What are biosimilars examples?
FDA-Approved Biosimilar Products
| Biosimilar Name | Approval Date | Reference Product |
|---|---|---|
| Semglee (Insulin glargine-yfgn) | July 2021 | Lantus (Insulin glargine) |
| Riabni (rituximab-arrx) | December 2020 | Rituxan (rituximab) |
| Hulio (adalimumab-fkjp) | July 2020 | Humira (adalimumab) |
| Nyvepria (pegfilgrastim-apgf) | June 2020 | Neulasta (pegfilgrastim) |
How are biosimilars manufactured?
Biosimilars are produced through an intricate, multi-step process, using living cells(2,3). This manufacturing information for the reference product is proprietary(4,5). The biosimilar manufacturer must therefore develop a new cell line and manufacturing parameters that result in a highly similar product(6).
What is the difference between biologics and pharmaceuticals?
A biologic is treatment which is derived from a biological method and is mainly composed of sugar, proteins, nucleic acids and maybe of living entities as cells and tissues. Pharmaceuticals on the other hand are chemically synthesized and their structure is known. Their mode of manufacturing is also different.
What is the approval process for biosimilars?
What is the approval process for biosimilar products? All FDA-approved biological products, including reference products and biosimilar products, undergo a rigorous evaluation so that patients can be assured of the efficacy, safety, and quality of these products.
What are biosimilars and why are they important?
Biosimilars are important because, much like generic drugs, they have an opportunity to create competition in the market, potentially drive down costs and expand patient access to critical medicines. An interchangeable product, in addition to being biosimilar, meets additional requirements based on further evaluation and testing of the product.
Are biosimilar and interchangeable biological products FDA approved?
FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product.
What is the FDA’s biosimilar pathway?
This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition. FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards.
What is the Biosimilars Council?
The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy.