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PTAB instituted two IPR petitions filed by Mylan challenging Regeneron’s US10,130,681 and US10,888,601 patents, which relate to Eylea® (aflibercept).  PTAB found that Mylan demonstrated a reasonable likelihood that at least claim 1 of the ‘681 patent and claim 34 of the ‘60...

BeiGene announced that the National Reimbursement Drug List released by China’s NMPA has been updated to include four new indications for its PD-1 inhibitor tislelizumab.  BeiGene’s Xgeva® (denosumab) was also renewed in the NRDL.  These updates will take effect from 01 Mar...

Celltrion filed a petition for inter partes review of Regeneron’s US 10,464,992, relating to Eylea® (aflibercept).  Celltrion has alleged the 992 patent is invalid on obviousness and anticipation grounds.  In August 2022, Regeneron sued Viatris (Mylan) for infringement of 2...

Significant biosimilar activities this week include:

16 Jan 23 | Dong-A ST publishes the results of Ph III trials of DMB-3115 (biosimilar ustekinumab)

Korea Biomedical Review reported that Dong-A STl has published the results of its global Ph III trials of DMB...

Business Korea has reported that Regeneron has filed patent infringement and prevention claims against Samsung Biologics and its subsidiary Samsung Boepis relating to Eylea® (aflibercept).  Regeneron claims that the Samsung Bioepis’ aflibercept (biosimilar to Eylea®) infrin...

Korea Biomedical Review reported that Dong-A STl has published the results of its global Ph III trials of DMB-3115 (biosimilar ustekinumab).  Dong-A ST reported that the study confirmed the therapeutic equivalence and safety of DMB-3115 compared to Janssen’s Stelara®.  DMB-...

Bio-Thera Solutions announced that China’s NMPA has approved BAT1806 (biosimilar tocilizumab) for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.

STADA and Xbrane announced that Ximluci® (ranibizumab, biosimilar to Roche/Genentech’s Actemra®) has been granted marketing authorisation by the MHRA. Under a July 2018 agreement, STADA and Xbrane are jointly responsible for development and manufacturing of Ximluci, while S...

Alvotech and Fuji Pharma announced an expansion to their existing exclusive commercialisation partnership in Japan, adding a new undisclosed biosimilar candidate.  The commercialisation agreement, which was first announced in 2018 and was most recently expanded in February ...