EMA clarifies antibodies development
European regulators have issued final guidance on how pharma manufacturers should develop drugs containing monoclonal antibodies.
Typically used in treatments for cancer and immune system diseases, such as rheumatoid arthritis, these are antibodies produced from a single clone of cells which attach to a specific target in the body.
After a six-month consultation with the industry, health professionals, patients and academia, the European Medicines Agency has published two documents which come into effect on 1 December.
biosimilars using these antibodies – which could start appearing on the market from next year – should be developed.
It concentrates on how manufacturers must demonstrate that the antibodies they use are comparable with those in the original, authorised drug.
The EMA has included a step-by-step guide for development programmes, covering such issues as in-vitro studies, efficacy and safety, and pharmacovigilance requirements.
The second document, the guideline on immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use looks at how patients’ own antibodies can lead to reductions in the effectiveness of such medicines, or even produce serious side effects.
The Committee for Medicinal Products for Human Use adopted the guidelines last month, and has also published a report from a workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies held in October last year.
One manufacturer does not believe the guidelines go far enough in some areas: Amgen says it ‘broadly supports’ the scientific principles behind the documents, but is concerned that the EMA only advocates recording just the ‘name’ of a medicine in adverse event reports.
Instead it wants the brand name to be captured to avoid confusion: “When multiple manufacturers are marketing different versions of a monoclonal antibody medicine, identification of exactly which product a patient receives will be far more difficult,” Amgen said in a statement.
“Prompt identification and resolution of product problems will be facilitated by distinguishable established names,” it concluded.
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