What is a biological product?
- Biological products, or biologics, are used to treat many illnesses, including chronic skin diseases, such as psoriasis; inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis; arthritis; kidney conditions; diabetes; and cancer.
- Biologics are generally large, complex molecules that are made from living sources such as bacteria, yeast, and animal cells.
- Because they generally come from living organisms, biologics inherently contain many slight variations from batch to batch, and their structures are generally more complex than those of other medications. As a result, biologics are often more complicated to purify, process, and manufacture.
- There are many types of biologics approved for use in the United States, such as monoclonal antibodies, insulin, vaccines, and allergenic products.
- Compared with a reference product, biosimilars:
- Are made with the same types of living sources
- Are given to the patient in the same way
- Have the same strength, dosage, potential treatment benefits, and potential side effects
- A biosimilar may be used in patients who have previously been treated with the reference product (treatment-experienced), as well as in patients who have not previously received the reference product (treatment-naïve).
- Biosimilars are like generic drugs in some ways, because both are versions of brand-name drugs and may offer patients more affordable treatment options.
- The main difference between biosimilars and generic drugs is that the active ingredients of generic drugs are generally smaller, simpler, and more straightforward to copy.
- Biologics generally cannot be copied exactly, because the products usually contain a mix of many slight variations of a protein, and this mix is never exactly the same in each dose or batch of the product.
- A reference product is approved in a stand-alone application that must contain data to demonstrate its safety and effectiveness, while a biosimilar is approved through an abbreviated pathway that generally avoids the need to conduct as many costly and lengthy clinical trials.
- A proposed biosimilar is compared to and evaluated against a reference product to verify that it is highly similar to and has no clinically meaningful differences in terms of safety, purity, and potency (i.e., safety and effectiveness) from the reference product.
- Analytical studies. Comparative analytical data provide the foundation of biosimilar development. These studies provide data to support the structural and functional similarity of the proposed product to the reference product and to evaluate the impact of any differences identified.
- Animal studies. These may provide toxicology or pharmacology information.
- A clinical study or studies. Pharmacology studies may demonstrate that the proposed biosimilar moves through the body in the same way and provides the same effects as the reference product. An immunogenicity assessment evaluates a patient’s immune response to the proposed biosimilar. Other comparative clinical studies are sometimes conducted after the completion of other studies to address any remaining uncertainty about whether the proposed biosimilar has any clinically meaningful differences from the reference product.
What is a biosimilar product?
A biosimilar is a biologic medication that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic, called a reference product.
Are biosimilars the same as generic drugs?
How does FDA review and approve biosimilars?
All FDA-approved biologics undergo a rigorous evaluation to help ensure their safety, effectiveness, and quality:
The biosimilar approval process provides assurance that biosimilars provide the same treatment benefits and risks as their respective reference products.
What is the difference between a biosimilar and an interchangeable biosimilar?
All FDA-approved biosimilars, including interchangeable biosimilars, must be highly similar to and have no clinically meaningful differences from the reference product in terms of safety and effectiveness. An interchangeable biosimilar is a biosimilar that meets additional requirements. A pharmacist may substitute an interchangeable biosimilar for its reference product without consulting the prescriber, depending on state pharmacy laws. FDA does not evaluate or approve a biosimilar as interchangeable unless a company requests it.
What is the approval process for biosimilar products?
A biosimilar is a biologic that is highly similar to and has no clinically meaningful differences in terms of safety, purity, and potency (safety and effectiveness) from an existing FDA-approved biologic, called a reference product. A reference product is a biological product that has been approved in a stand-alone application that contains all data to demonstrate the product’s safety and effectiveness for each of the indications being sought by the manufacturer and is the product against which a proposed biosimilar is evaluated. Biosimilars are evaluated for approval based on all the evidence presented by the manufacturer.
FDA approves biosimilars through an abbreviated pathway. The goal of a biosimilar development program is to demonstrate biosimilarity between the proposed biosimilar and its reference product, not to independently establish the safety and effectiveness of the proposed biosimilar. This generally means that biosimilar manufacturers do not need to conduct as many expensive and lengthy clinical trials.
An application for a proposed biosimilar generally must include information showing that the proposed product is biosimilar to a reference product. Below is some information on the data typically included in an application.
FDA has discretion to determine that an element is unnecessary in a proposed biosimilar application.
FDA evaluates all the evidence, based on comparisons between the biosimilar and the reference product, in the context of the Agency’s previous finding that the reference product is safe and effective.
For details and accuracy, please check with FDA website:
https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals
