Guiding the path to biosimilarity

As the importance of Biosimilars in today’s market rapidly increases, we offer our in-depth expertise for conducting clinical trials in this area. The production of highly complex Biosimilar is intricate - they can only be produced by means of living organisms and require additional quality studies like bioequivalence studies to compare the structure and biological activity of the Biosimilar with the reference medicine. These drugs offer new innovative approaches and if you choose to enter this promising field we provide you with a comprehensive trial service for bringing your Biosimilar to the market.

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We assist you in choosing the optimal development strategy and will identify passionate investigators, sites and analysts for ensuring quick and sophisticated trial execution. Our team has the know-how needed in conducting clinical trials, developing regulatory strategies and realizing projects within budget and on time. Additionally, we closely interact with KOLs for the strategic development of your Biosimilar. Furthermore, our clinical studies often integrate pharmacokinetic evaluations to confirm clinically relevant metabolic differences between the proposed Biosimilar and the reference product.

 

Key aspects and challenges of Phase III clinical trials depend on the characteristics of the Biosimilar. Thus we provide you with customized and flexible study designs and offer a full set of leveraging support both within our own services and with selected partners to manage your clinical trial for Biosimilar and exploring new market options.

Our Biosimilar development service includes

Development of customized Biosimilar study concepts

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Consulting at every stage of the process

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Planning, managing and conducting of comprehensive controlled clinical trials (Phase I, II, III clinical trial service)

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Pharmacokinetic profiling of your Biosimilar

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Thorough extrapolation after similarity is proved as part of the regulatory strategy

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Communication and consultation with regulatory authorities

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“Inspire and being inspired – our network of partners, sites and KOLs makes us ready to meet every challenge.”

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