Biologics development often involves global markets, each with its own regulatory requirements. Harmonising regulatory strategies across these different regions can be complex.
Biosimilar developers face obstacles in demonstrating similarity to a reference biologic and interchangeability with it. This, coupled with the challenges of finding appropriate cross-border regulatory advice, leads to delays in product launches and expensive, lengthy, and fragmented multi-country development.
Compared with the well-established development and approval processes for new chemical entities (NCEs) and small-molecule generics, the framework for new biological entities (NBEs) and biosimilar products is highly complex and ever-evolving.
We can guide you in establishing robust and consistent strategies to ensure product quality and safety, and our regulatory experts can help you compile and submit approval documentation to ensure regulatory compliance.
