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New Biological or Chemical Entities
These are structurally unique medicines that are either developed against new targets (e.g a receptor, enzyme, protein, gene, etc.) thought to be dysfunctional in patients or against a known target and/or disease. Their development takes many years and significant investment and have unique development challenges to overcome before they can enter the clinic and ultimately progress to market.
Biosimilars
These are biological medicines that are developed to be “highly similar” to an innovator (reference product). They must have an identical primary amino acid sequence to an innovator (reference) product and shown through extensive characterization and comparative evaluation to be “highly similar” to their reference products, in terms of structure, function, efficacy, safety and immunogenicity.
Biosmilars usually take 2-4 years to develop because the target receptors and indications are already known, but they have their own regulatory approval pathway, which is evolving quickly.
Generic and Hybrid Medicines
Generic medicines are chemically synthesized medicines that contain the same active substance(s) as the reference medicine, and it is used at the same dose(s) to treat the same disease(s). However, a generic medicine's inactive ingredients, name, appearance and packaging can be different.
Hybrid medicines are medicines whose authorisation depends partly on the results of tests on the reference medicine and partly on new data from clinical trials. This happens when a manufacturer develops a generic medicine that is based on a reference medicine, but has a different strength, a different route of administration or a slightly different indication from the reference medicine.
Combination Products
Combination products can include combinations of the following types: drug-device, biologic-device, drug-biologic and drug-device-biologic. They pose significant challenges to developers and it is important to understand the regulatory and data requirements needed to support approval
