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Genentech Files First Pertuzumab BPCIA Complaint Against Shanghai Henlius and Organon

On August 14, 2025, Genentech, Inc. and Hoffman-La Roche Inc. (together, “Genentech”) filed a BPCIA complaint in the U.S. District Court of New Jersey against Shanghai Henlius Biotech, Inc. and Shanghai Henlius Biologics Co.,...more

Biocon Regulatory Approval Updates in the U.S. and Europe: Insulin Aspart and Denosumab

On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and...more

Accord Biopharma Announces FDA Approval of IMULDOSA (ustekinumab-srlf)

​​​​​​​On October 14, 2024, Accord BioPharma, Inc. announced that the FDA has approved IMULDOSA (ustekinumab-srlf), a biosimilar to Johnson & Johnson’s STELARA (ustekinumab), indicated for the treatment of chronic...more

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