WHAT IS BIOLOGIC OR BIOLOGICAL MEDICINE?
Biologics (including biosimilar medicines) come from living organisms, such as living cells that have been modified using biotechnology to produce the active substance of biological medicine. Available biologics include hormones such as insulin and growth hormone and monoclonal antibodies to treat several diseases.
WHAT IS A BIOSIMILAR MEDICINE?
A biosimilar is highly similar to, and has no clinically meaningful differences in safety, purity, and potency (safety and effectiveness) from, an existing FDA-approved reference product.
The reference product is the single biological product, already approved by FDA, against which a proposed biosimilar product is compared.
ARE BIOSIMILARS MEDICINES EXPECTED TO BE SAFE AND EFFECTIVE?
Biosimilar medicines undergo a rigorous regulatory approval process to ensure efficacy, safety and quality. For their approval, the biosimilar`s manufacturer must demonstrate that the biological product is similar and has no clinically meaningful difference between it and the reference medicine.
Like any approved medicine, biosimilar medicines can be expected to be safe and effective treatment options when used appropriately in their approved indications.
As with any treatment, it is essential to have a thorough conversation with your prescribing doctor about all the available therapeutic options, their safety, benefits and risks, and the differences between the medicines before deciding.
WHAT IS THE DIFFERENCE BETWEEN A BIOSIMILAR AND A GENERIC MEDICINE?
As explained by the FDA, biosimilars and generic drugs are versions of brand name drugs and may offer more affordable treatment options to patients. Biosimilars and generics are each approved through different abbreviated pathways that avoid duplicating costly clinical trials. But biosimilars are not generics, and there are important differences between biosimilars and generic drugs.
For example, the active ingredients of generic drugs are the same as those of brand name drugs. In addition, the manufacturer of a generic drug must demonstrate that the generic is bioequivalent to the brand name drug.
Unlike traditional small-molecule medications, which have standard production methods and well-defined structures, biological products have a sophisticated manufacturing process that involves the use of living cell cultures. This process can result in heterogeneous products with slight variations in manufacturing.
Visit https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products#generic to learn more.
HOW DO BIOSIMILARS MEDICINES SUPPORT ACCESS, CHOICE, AND VALUE?
Several diseases can be treated with biologics. However, the patient`s access to this type of medicine can be limited due to the complexity and high cost. Biosimilar medicines are an effective and safe option for a given treatment but often available at lower prices.
CAN I BE SWITCHED FROM A BIOLOGICAL TO A BIOSIMILAR MEDICINE?
As a similar product, it is possible to switch from a reference medicine to a biosimilar medicine, and this is a growing practice worldwide. Any decision on switching should be taken by your doctor in consultation with you, and taking into account any policies that your country might have regarding the use of biological medicines. For questions related to switching from one biological medicine to another, patients should speak to their doctor, pharmacist, or specialist nurse.