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Biological products

A biological medicine is defined as a medicinal product whose active substance is made by a living organism. This includes medicinal products that are produced using recombinant or transgenic technology and also medicines based on genes, tissues or cells, so called advanced therapies. They are relatively complex molecules usually consisting of proteins, carbohydrates, nucleic acids, cells or tissues for transplantation, or a complex composite of these substances.

Examples include hormones, vaccines, blood products, monoclonal antibodies, recombinant therapeutic proteins, gene and cellular therapies.

Innovator medicines

These are biological medicines that are usually developed against new targets (e.g a receptor, enzyme, protein, gene, etc.) that are involved in a biological process thought to be dysfunctional in patients with a disease or they are developed to target a known target and/or disease but the structure and functional attributes of the molecule are unique.

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. 


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.

Re-purposed medicines

This identifies new uses for medicines that are outside of the scope of the existing license. This typically involves taking an existing medicine that already has a marketing authorization for human use for a particular condition, and then using it to treat another condition.

Alternatively, a repurposed medicine may be used in a different dose, or form, than its original license (for example an inhaled product, rather than a tablet).

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 innovator and biosimilar developers and it is important to understand the regulatory requirements in each jurisdiction

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