Accelerating Biosimilar Development Programs using Contract Testing and Manufacturing Organizations

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A rapid increase in the number of companies working on the development and registration of biosimilars and the need to get these products to market with speed has lead biosimilar developers to turn to contract research organizations (CROs) when they lack either the internal capability or capacity for conducting certain work.

Throughout the biosimilar development pathway, a product sponsor can choose to conduct the work itself or use service contractors. Contractors can be niche providers of a single aspect of a program or large, multifaceted organizations that provide a portfolio of services. The fewer contractors a company uses results in greater synergies and efficiencies and offers similarity of documentation and less of an audit and management burden on a developer. As product knowledge is key to efficient and effective testing programs, companies should place careful consideration on the CRO’s history working with biosimilar or originator biologic products when evaluating them.

Our recent paper discusses the different phases of biosimilar development, how contract research and manufacturing organizations can play a role in these steps and what product sponsors should consider when evaluating different outsourcing providers.