Knowra Biosimilar Biosimilar A biological medicine highly similar to an already approved reference product, with no clinically meaningful differences in safety, purity, or potency.
Biopharmaceutical : A medicine produced using biological sources or processes, such as cells, proteins, or genetic engineering. Biosimilars belong to this broader class of medicines.
Comparative analytical assessment : A detailed comparison of the structure and functional properties of two biological medicines. It is the foundation for demonstrating biosimilarity.
Infliximab biosimilar : A biosimilar version of infliximab, a monoclonal antibody used to treat inflammatory diseases. Infliximab biosimilars illustrate use of the category in immune-mediated conditions.
Generic drug : A medicine containing the same active ingredient as an approved small-molecule drug and meeting applicable equivalence standards. Generics can generally match a chemically defined molecule exactly; biosimilars cannot.
Biologic patent cliff : The period when patents and exclusivities for major biological medicines expire, allowing competing products to enter. Patent expiry creates opportunities for biosimilar development and market entry.
Monoclonal antibody : A laboratory-produced antibody designed to bind a specific target, often used as a medicine. Many biosimilars are copies of complex therapeutic antibodies.
Pharmacokinetics : The study of how a medicine is absorbed, distributed, metabolized, and eliminated by the body. Comparative studies assess whether the products behave similarly in the body.
Filgrastim biosimilar : A biosimilar version of filgrastim, a protein that stimulates production of neutrophils. Filgrastim biosimilars are used to support white-blood-cell recovery in appropriate patients.
Biologic : A medicine whose active substance is made from or derived from living organisms. The broad biologic category includes reference products and biosimilars.
Drug price competition : Competition among medicine suppliers that can influence prices, availability, and market share. Biosimilar entry can increase competition, though price effects vary by market.
Show all 28