Adaptation of the Guidance document Authorisation biosimilar HMV4


Inclusion of LMWH as biosimilars with corresponding additions in sections 1 to 4, 7.4 and 8, further details in section 5.4.1 explaining why it is appropriate to use a foreign comparator product instead of the Swiss reference product and clarifying that the DMF concept is not applicable to biological active substances (section 7.4). Correction: authorised by the European Commission not the EMA.

The new version of the affected document enter into force as of 29.05.2019.