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Novartis announced that Sandoz signed an MOU to build a new biologics production facility in Lendava, Slovenia.  The investment is expected to be worth at least USD$400M and is one of the largest international private sector investments in Slovenia.  Work on the new plant i...

Sanofi and Regeneron announced that the FDA has accepted their sBLA for Dupixent® (dupilumab) to treat chronic spontaneous urticaria.  The FDA’s decision is expected on 22 October 2023.  The sBLA relied on data from two phase III trials (LIBERTY-CUPID Studies A and B). 

An Extrapolate Research report estimates that the biologics and biosimilars market is likely to upsurge by US$271.5 billion globally by 2028.  The report claims that monoclonal antibodies dominate the market.  

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Significant biosimilar activities this week include:

28 February 2023 | IN | Enzene Biosciences begins supply of Humira® (adalimumab) biosimilar in India  

Biospectrum India reported that Enzene Biosciences has launched its adalimumab (biosimilar to AbbVie’s H...

Coherus announced that the FDA has approved its single-dose, prefilled autoinjector presentation of Udenyca® (pegfilgrastim-cbqv) biosimilar to Amgen’s pegfilgrastim (Neulasta®) as an additional presentation on 3 March 2023.  This the only US approved PFS presentation of pe...

Janssen Biotech, Inc. has filed another motion for a preliminary injunction against Amgen regarding its ustekinemab biosimilar, after its original motion was denied by US District Court Judge Noreika on 2 March 2023.  Janssen is seeking to enjoin Amgen, Inc. from manufactur...

MiGenTra, a German healthcare transforming company, announced the commencement of the German phase I trial of Minapharm Pharmaceuticals’ African developed adalimumab biosimilar (Adessia®) on 24 February 2023.  Results are expected at the end of 2023.

MiGenTra was fou...

A study published in BioDrugs found that there was no difference between rituximab biosimilars (Truxima® (Teva Pharmaceuticals), Rixathon® (Sandoz) and Ruxience® (Pfizer)) and the originator product (Roche’s MabThera®) for hypersensitivity reactions (at initiation, switch o...

Biogen and Eisai Co announced that the FDA has accepted their sBLA and has granted priority review for traditional approval of LEQEMBI™ (lecanemab) for treatment of Alzheimer’s disease.  It was approved under the Accelerated Approval Pathway on 6 January 2023 (approval base...