Platform overview
Biologic medicines and biosimilars
What are biologic medicines?
Biologic medicines are medicines whose active substances are produced by, extracted from, or otherwise derived from living sources. Many modern biologics are large and structurally complex molecules, including monoclonal antibodies, recombinant proteins, insulin products, vaccines, and other biological products.
Therapeutic proteins may be produced using engineered living cells, including mammalian-cell culture systems operated in bioreactors. Their molecular characteristics can be influenced by the cell substrate, culture conditions, purification process, formulation, and storage conditions.
Because biologics may contain a controlled distribution of molecular variants, their development requires extensive physicochemical and functional characterization together with appropriate process understanding and control. The clinical use, indications, and benefit-risk profile of each biologic are specific to the individual product and its regulatory authorization.
What are biosimilar medicines?
A biosimilar is a biological medicine that the relevant regulatory authority has determined to be highly similar in quality characteristics to an already authorized reference biological medicine, with no clinically meaningful differences in safety and efficacy.
That determination is based on the totality of comparative evidence, with analytical and functional studies forming the foundation and additional nonclinical or clinical evidence included as required by the applicable regulatory pathway.
Before authorization, a development-stage product should be described as a proposed biosimilar or biosimilar candidate, not as an approved biosimilar. Interchangeability, where such a designation exists, is a separate regulatory determination and must not be implied.
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Explore the proposed biosimilar candidates in our research portfolio.
- A development-stage product should be described as a "proposed biosimilar" or "biosimilar candidate." Biosimilarity, approved indications, interchangeability, safety, and efficacy can be stated only after the relevant regulatory authority has completed its assessment and granted the corresponding authorization.