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The U.S. Food and Drug Administration (FDA) has approved biosimilars (Biosimilars) to treat conditions such as cancer, Crohn's disease, colitis, rheumatoid arthritis, and psoriasis candle. But what exactly are biosimilars?1. Biologic drugs: Medicines from living organisms
A biosimilar is a biosimilar, which is a biological product that is very similar to a reference biological product and is clinically relevant and clinically relevant in terms of safety, purity, and efficacy.An example of an approved biosimilar is Amjevita (adalimumab-atto), the first biosimilar to be approved and used to treat rheumatoid arthritis and psoriasis, among others. many other uses.
However, biosimilars are not considered generic drugs or generic drugs. Biosimilars are one of the fastest growing segments of the prescription products market. FDA approval of complementary and interchangeable biosimilars will help stimulate competition. Patients will have more treatment options and potentially less cost than approved products.
Biosimilars are drugs that are usually derived from living organisms, which may include animals and microorganisms such as yeast and bacteria. That makes Biosimilars different from conventional drugs that are often made from chemicals.
Unlike conventional drugs, Biosimilars cannot be created by following a chemical formula. Because biology usually comes from living organisms, their nature is different and their structure is more complex. Therefore, developing Biosimilars can require a difficult process compared to manufacturing conventional drugs. Biosimilars are biological products that are very similar and are not clinically different from another FDA-approved biological product (called a parent or reference product). Biosimilars are made with the same natural sources as the original drug they were compared to, they are taken in the same way, have the same strength, the same dosage, and the same potential side effects.
Không giống như các loại thuốc thông thường, Biosimilars không thể được tạo ra bằng cách làm theo một công thức hóa học
2. Are biosimilars safe and effective?
Biosimilars are as safe and effective as the original biologic because both are rigorously and thoroughly evaluated by the FDA prior to approval. In order to approve a biosimilar, FDA experts must conclude that it is very similar to the parent biosimilar and has no clinically significant difference from the original biosimilar. This means you can be assured of the same safety and effectiveness from a Biosimilar during your treatment. This thorough evaluation helps ensure that all biosimilar products are as safe and effective as their reference products and meet the high standards of FDA approval.In addition, FDA also strictly regulates the production of biosimilars. The same manufacturing standards apply as the original biological product. Drugs must be manufactured according to the methods, facilities, and control requirements for the manufacture, processing, packaging or storage of a medicinal product. This helps prevent manufacturing errors and unacceptable impurities and ensures product quality.
Biosimilars an toàn và hiệu quả như thuốc sinh học ban đầu vì cả hai đều được FDA đánh giá nghiêm ngặt và kỹ lưỡng trước khi phê duyệt
3. Biosimilar drugs are interchangeable
A substitute product is a biosimilar drug when they can meet the additional requirements approved by the FDA. Because once such drugs are approved by the FDA, they can be replaced at the pharmacy without the intervention of healthcare professionals in the same way that generic drugs are often substituted for brand-name drugs.Because of FDA's very high standards, healthcare providers can be confident in the safety and effectiveness of a biosimilar or a substitute product that is similar to that of a product. FDA-approved reference product.
The law that allows the FDA to approve biosimilar drugs has also changed. For example, insulin and certain other drugs, such as human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin and menotropin are converted from being approved under the Federal Food, Drug and Cosmetic Act. State is licensed as a biologic under the Public Health Service Act.
Thuốc sinh học là một trong những phân khúc phát triển nhanh nhất của thị trường sản phẩm kê đơn
Therefore, when choosing any product or drug for treatment, the patient must necessarily consult and obtain the consent of the doctor. Self-use always has many health risks.
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References: fda.gov - drugs
