Drug Regulators, EMEA, Publish Concept Paper on the Development of a Guidance on Similar Biological Medicinal Products Containing Monoclonal Antibodies

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Monoclonal Antibodies (mAbs) comprise a large important class of therapeutic biologicals. Different mAb products share some properties, e.g. on a functional level, but differ in aspects like the mechanism of action. The complexity of mAbs is a challenge for the development of new mAb products that are claimed to be similar to marketed mAbs. Nevertheless, such mAbs are being developed, and CHMP has given scientific advice for the development of some individual products. This guideline lays down the non-clinical and clinical requirements for monoclonal antibody-containing medicinal products claiming to be similar to another one already marketed, i.e. similar biological medicinal products (biosimilars). It may also include a chapter on quality aspects more pertinent to biosimilar monoclonal antibodies, should BWP/BMWP consider it necessary. The non-clinical section addresses the pharmaco-toxicological assessment. The clinical section addresses the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as the risk management plan.

Guidance for development of biosimilars is already available, including class-specific guidance. With monoclonal antibodies, a next step is taken towards more complex and large molecules. Whilst available guidances (Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues, CHMP/49348/05; Production and Quality Control of Monoclonal Antibodies and Related Substances, CHMP/BWP/157653/07) appear to provide sufficient guidance on quality of biosimilar mAbs, there are several issues pertinent to non-clinical and clinical development that are not sufficiently covered by current guidances. There are several areas of increased complexity as regards design of a biosimilar development programme in these fields, which require careful consideration and exploration of further science-based approaches.
The guideline has in its main focus monoclonal antibodies, but principles may also be applicable to related proteins like, for example, fusion proteins.

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