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Samsung Bioepis has filed an IPR in the US against Alexion’s Soliris® (eculizumab) patent 10,703,809 (’809 patent) advocating that all claims of the ‘809 patent are obvious in light of the prior art (including patent applications, a granted patent, manuscripts and a journal...

Samsung Bioepis has filed an IPR against Janssen’s US patent no. 10,961,307 (‘307 patent) relating to Stelara® (ustekinumab).  Samsung Bioepis argues that all claims of the ‘307 patent are invalid. Claims 1-4, 6-22, and 24-34 allegedly lack novelty and are anticipated by a ...

Xbrane Biopharma announced the FDA has accepted a supplemental Biologics License Application (sBLA) for its biosimilar to Genentech’s Lucentis® (ranibizumab) to treat serious eye diseases such as wet age-related macular degeneration, macular edema following retinal vein occ...

LOTTE Biologics announced it has signed a memorandum of understanding with LOTTE Corporation, Incheon Metropolitan City and the Incheon Free Economic Zone to establish biologics production facilities in the area.  LOTTE Biologics plans to construct three mega plants by 2030...

BusinessWire reports that Bio-Thera Solutions and Biomm SA have reached a licensing and supply agreement for BAT2206 (ustekinumab biosimilar).  Under the agreement, Biomm will have exclusive rights to distribute and market the product in Brazil.

We previously reporte...

MSD announced that it has acquired Prometheus Biosciences, Inc. which is now a wholly-owned subsidiary of MSD.  Prometheus’ leading candidate product PRA-023 (now known as MK-7240), is a humanized monoclonal antibody being developed to treat immune-mediated diseases such as...

The Economic Times in India reported that Glenmark provided a drastic price drop in India for Trumab® (trastuzumab), biosimilar to Genentech’s Herceptin®.  Glenmark reduced the cost of its 440mg vial from ₹54,000 down over 70% to ₹15,749 in a market supplying the medicine f...

Genentech announced that the FDA approved Columvi® (glofitamab-gxbm) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or mo...

Sandoz announced its new Act4Biosmilars Action Plan as part of its Act4Biosimilars initiative that aims to increase the adoption of biosimilars in over 30 countries by 30% by 2030.  The Plan features 12 initiatives to help accelerate biosimilar uptake, examining accessibili...