NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products

A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (the RP). The guiding principle of a biosimilar development programme is to establish similarity between the biosimilar and the RP based on a comprehensive comparability exercise, ensuring that the previously proven safety and efficacy of the RP also apply to the biosimilar.

In line with CHMP guidance, there is no regulatory requirement to repeat the demonstration of biosimilarity against the RP (e.g. in the context of a change in the manufacturing process), once a product licence for the biosimilar has been granted

Confirmatory efficacy trial

Although each biosimilar development needs to be evaluated on a case by case basis, it is considered that, in most cases, a comparative efficacy trial may not be necessary if sound scientific rationale supports this approach. Therefore, a well-argued justification for the absence of an efficacy trial should be appended to CTD Module 1 of the submitted application.

Applicants are encouraged to seek scientific advice to discuss this approach as soon as they have sufficient comparative analytical and functional data to support it. However final acceptance of this approach would only be considered after submission of the complete data package. The general principles to be used in this justification are summarised hereafter.