The US FDA has issued complete response letters (CRL) for the Rituxan and Herceptin biosimilar candidates after Celltrion’s facility received a warning in Janaury.
Mundipharma says it is not concerned at arriving second to market with a trastuzumab biosimilar after inking a deal to commercialise Celltrion’s Herzuma in seven European countries.
Charles River says increased demand for biologics services prompted its recent Devon Park facility acquisition, bringing its Pennsylvania site count to three
A warning letter at manufacturing partner Celltrion could delay approvals of the potential migraine prevention monoclonal antibody fremanezumab and two biosimilar candidates, says Teva.
Patient advocacy groups have called on Congress to address patient safety concerns in oversight hearings, following an influx of US FDA biosimilar drug approvals.
Amgen has announced plans for a US biomanufacturing facility, similar to its flexible and single-use Singapore plant, as part of $3.5bn freed through tax reforms.
Cellular Biomedicine Group Inc (CBMG) has selected GE Healthcare’s FlexFactory technology for its CAR-T therapy production facility in Shanghai, China.
Celltrion has shelved plans for a third biomanufacturing plant at its site in Incheon in favour of an overseas site it says will help ensure biosimilar supply.
Did you miss any of the biosimilar approvals, launches or guidance this year? Well Biopharma-Reporter brings you a special timeline of events to help guide you into the new year.
Pfizer says it remains committed to Inflectra and partner Celltrion after gaining US FDA approval for another infliximab biosimilar, Ixifi, developed in-house.
The US FDA has approved Admelog as a follow-on drug five months after it received European market authorisation as a biosimilar of Eli Lilly’s Humalog (insulin lispro).
The EMA has accepted to review Mylan’s trastuzumab and pegfilgrastim biosimilars amid remediation efforts at biomanufacturing partner Biocon’s fill and finish plant in India.
Physicians and patients still lack information about biosimilars says an industry consultant, despite efforts from advocacy groups and national healthcare systems.
Samsung Bioepis has received European Commission approval for Ontruzant, its version of Roche’s best-selling breast cancer mAb Herceptin (trastuzumab).
Janssen has withdrawn a lawsuit against Samsung Bioepis alleging infliximab manufacturing patent infringements after receiving process information from the Korean drugmaker.
Mvasi has been recommended for approval in Europe, but a duplicate marketing authorisation application for an Avastin (bevacizumab) biosimilar has been withdrawn by Amgen.
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.
