1. What is a biosimilar?
A biosimilar is a biological medication that is highly similar to the original product. Biosimilars have no clinically meaningful difference from the original product. This means that you can expect the same safety and effectiveness from the biosimilar when comparing it to the original product. Biosimilars are made from the same sources (e.g., living cells or microorganisms).
2. What approval standards do biosimilar have to meet?
The manufacturers should provide non-clinical and clinical studies to support the similarity of the structure, composition, quality, safety, and efficacy between the biosimilar and the original product to an approval agency before it can be registered for use.
3. Is there any difference between receiving a biosimilar and an original product?
Patients and their health care providers can expect no clinically meaningful difference between a biosimilar and an original product when these products are used as intended. Once a biosimilar has been approved by the National Pharmacy Regulatory Agency (NPRA) of Malaysia, patients and health care providers can be assured of the safety and effectiveness of the biosimilar, just as they would for the original product.
4. What do you mean by extrapolation?
Extrapolation is a core concept for biosimilars. If the biosimilar manufacturer can provide a total evidence that supports the bio-similarity of the biosimilar for at least one of the original (reference) products’ indication, the biosimilar manufacturer can use that bio-similarity data and information to get approval for other indications that were not directly studied by the same biosimilar manufacturer. Extrapolation is based on sufficient scientific justifications and the totality of the evidence.
5. Can a biosimilar be used for all the indications listed in the original product?
A biosimilar may have all or fewer indications than those listed in the original product, especially if the patent of the exclusivity of certain indications of the original product has not expired. It is best to review what the approved indications are, which can be found in the product information leaflet.
6. What is an interchangeable biosimilar?
An interchangeable biosimilar is a product that is expected to produce the same clinical effects as the original product in any given patient. In terms of the risk of diminished efficacy while interchanging (switching or alternating) between the biosimilar and its original product, it is not greater than the risk of using the original product alone. A systematic review which evaluated the impact of switching biosimilar from original product showed no increase in treatment related safety event or loss of efficacy. The decision to use a biosimilar should be based on the patient’s confidence regarding the biosimilar and its cost.
For further information on these FAQ, please click into the links below:
- Biosimilar and Interchangeable Products
https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products- Biosimilar Development, Review and Approval
https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval- Prescribing Biosimilar and Interchangeable Products
https://www.fda.gov/drugs/biosimilars/prescribing-biosimilar-and-interchangeable-products- Biosimilar Product Information
https://www.fda.gov/drugs/biosimilars/biosimilar-product-information- Industry Information and Guidance
https://www.fda.gov/drugs/biosimilars/industry-information-and-guidance- Webinars, Presentations and Articles
https://www.fda.gov/drugs/biosimilars/webinars-presentations-and-articles- Health Care Provider Materials
https://www.fda.gov/drugs/biosimilars/health-care-provider-materials