The world’s largest single bioproduction plant has received its first US regulatory approval to make a monoclonal antibody, says CDMO Samsung Biologics.
Mylan and Biocon have received a complete response letter for a version of Amgen’s Neulasta (pegfilgrastim) in the latest regulatory blow to their biosimilar ambition.
Pfizer has accused J&J of restricting biosimilar uptake through uncompetitive practises in its efforts to maintain a monopoly for its bestselling mAb Remicade (infliximab).
Fears of Remicade competition have not manifested in significant growth declines for Johnson & Johnson, but Pfizer says US payers and physicians are slowly getting comfortable with biosimilars.
The US FDA has approved its sixth biosimilar and second version of AbbVie’s best-selling monoclonal antibody Humira (adalimumab): Cyltezo, made by Boehringer-Ingelheim.
Imraldi becomes the second version of AbbVie’s best-selling biologic Humira (adalimumab) to be approved and the fourth biosimilar success for Samsung Bioepis in Europe.
The US FDA has accepted submission of two further Herceptin (trastuzumab) biosimilars: ABP 980 developed by Amgen and Allergan, and Teva and Celltrion’s CT-P6.
Roche is confident its biologics pipeline and plan to reformulate some of its top selling monoclonal antibodies can offset sales erosion resulting from biosimilar competition.
Pfizer dropped the US price of Inflectra, its version of Johnson & Johnson's Remicade, just weeks before Merck & Co. launched its infliximab biosimilar, Renflexis.
