NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

From the MHRA document on biosimilar

A biosimilar should be highly similar to the RP in physicochemical properties, biological activity/potency and clinical profiles. In addition, biosimilar development requires that the impurity profile and the nature of excipients of the biosimilar itself do not give rise to concerns. Any observed differences must be duly justified with regard to their potential impact on safety and efficacy. For an active substance that is a protein, the amino acid sequence is expected to be the same, other than justified post-translational modifications.

The posology (dose and frequency of dosing) and route of administration of the biosimilar must be the same as those of the RP but deviations from the RP are possible, such as the strength (for example, higher concentration to allow for a smaller injection volume, more suitable for paediatric indications), pharmaceutical form, formulation, excipients or presentation. These require justification and may need additional data. Patient acceptability should also be considered.