NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Thanks for sharing Chiugray. You are right and Ex is wrong. DCVax-L is considered an ATMP (Advanced Therapy Medicinal Product) and not a Biosimilar ATMP. DCVax-L manufactured in a closed system is not a “Biosimilar DCVax-L”. Ex statement is incorrect. Guidance on biosimilars does not apply to DCVax-L, as it is not a biosimilar product.
Here is the definition of biosimilar ATMPs:

Specificities of the marketing authorisation dossier for biosimilar ATMPs.

Introduction

A similar biological medicinal product - hereinafter ‘biosimilar’ - is a biological medicinal product (medicine containing active substances made by or derived from a biological source such as living cells or organisms) highly similar and therapeutically equivalent to an already approved biological medicinal product (the ‘reference medicinal product’) in the European Union, which has lost its patent exclusivity protection. The biological medicinal products include the Advanced Therapy Medicinal Products (ATMPs).

There are no Biosimilar ATMP’s authorised in the European Union.

Biosimilar ATMPs shall be authorised at the European Union level. However, we are not aware of any of such product having been authorised in the European Union. This is probably because the technical complexity of the ATMPs manufacturing process as well as the variability of the biological sources is reducing the potentiality for ATMPs’ biosimilarity to be undertaken and demonstrated.

https://www.eurogct.org/research-pathways/commercialisation/market-access-atmps/expediting-marketing-authorisation-3
Mark Lowdell:

“If you have manufactured a product in an open system for pre-clinical studies or early clinical trial you have to demonstrate that the transfer to a closed system (or any ofther substantial change to the manufacturing process) delivers an equivalent product. It is wrong to use the term biocompatibility – you need to show equivalence.”

Mark Lowdell and his comment about the number of “validation runs”:

"This depends upon the risk assessment of your product. Typically autologous products present data from 3-5 process validation runs whereas an allogeneic product from a large cell bank might present as many as 10. Never hundreds."