Significant biosimilar activities this week include
March 20 | The UK High Court ruled filing errors in a Supplementary Protection Certificate (SPC) for Lucentis® (ranibizumab) have cut almost two years from Roche/Genentech’s protection in the UK. These errors arose when a third party engaged by Roche/Genentech failed to pay the full lump sum fees at the start of the SPC term.
20 March 20 | Biocon announced it had received an Establishment Inspection Report from the FDA, clearing its manufacturing facility in Bengaluru.
24 March 20 | Alvotech and DKSH announced an exclusive license partnership for the commercialisation of AVT02 (adalimumab candidate) in 36 emerging countries in South-East Asia. Under the agreement, Alvotech will be responsible for development and supply and DKSH will be responsible for registration and commercialisation.
24 March 20 | Samsung Bioepis announced the FDA has approved its 420mg multi-dose vial of Ontruzant® (trastuzumab).
26 March 20 | iBio and AzarGen Biotechnologies announced that they have entered into a second Statement of Work under their Master Joint Development Agreement. Under this agreement, iBio will assist AzarGen in the manufacture and characterisation of supplies to enable pre-clinical studies of a rituximab biosimilar.
26 March 20 | Janssen was granted the additional indication of ulcerative colitis for Stelara® (ustekinumab) in Japan.
27 March 20 | Mylan and Lupin announced the EU’s CHMP has adopted a positive opinion recommending Nepexto® (etanercept) for all indications as Enbrel®.