Biosimilars Handbook by European Generic Medicines Association

By European Generic Medicines Association

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The amount of non-clinical data required is specific to the product, and will be determined on a case-by-case basis. Usually the following non-clinical tests are included: • A short-term toxicological repeated dose study (typically 4 weeks) • Pharmacokinetic/pharmacodynamic studies in an appropriate animal model • Local tolerance testing CLINICAL DATA The registration dossier for a biosimilar medicinal product will usually include clinical data, summarising the results of clinical trials conducted in patients and healthy volunteers with the biosimilar product.

Omnitrope® and Valtropin®) and both contain the same active substance, somatropin. Somatropin is the scientific name for this active substance. The scientific name is usually called the INN (International Non-proprietary Name), which may sometimes be known as the generic name. The INN is also approved by the EMA during the scientific evaluation of the biosimilar medicine. The name of a medicine is very important for clear identification, safe prescription and dispensing, as well as for monitoring the safe use of the medicine during the whole life-cycle.

To achieve these goals, a comprehensive toolbox of analytical, biological and process engineering techniques is already available to allow for the optimisation of the manufacturing process and subsequently the determination of comparability between the final biosimilar mAb and the reference product. Current expertise at the EU regulatory agencies and the European Medicines Agency for a sound scientific assessment is based on their experience gained from reviews of many originator mAb products, including the assessments made of the many manufacturing changes of these products, which have taken place over many years, as well as the assessment of numerous biosimilar applications.

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