Significant biosimilar activities this week include:
At the beginning of March 2020, 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.
On 20 March 2020, Biocon announced it had received an Establishment Inspection Report from the FDA, clearing its manufacturing facility in Bengaluru.
On 24 March 2020, 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.
On 24 March 2020, Samsung Bioepis announced the FDA has approved its 420mg multi-dose vial of Ontruzant® (trastuzumab).
On 26 March 2020, 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.
On 26 March 2020, Janssen was granted the additional indication of ulcerative colitis for Stelara® (ustekinumab) in Japan.
On 27 March 2020, Mylan and Lupin announced the EU's CHMP has adopted a positive opinion recommending Nepexto® (etanercept) for all indications as Enbrel®.