After a phase 3 study showed a promising pCR rate with HLX11, the pertuzumab biosimilar’s BLA has been accepted for review by the FDA. A biologics license application (BLA) for HLX11, an ...

FDA reviews biologics license application for HLX11, a biosimilar to pertuzumab, for HER2-positive breast cancer. The FDA accepted for review a biologics license application (BLA) seeking the approval ...

(“Henlius”) announced FDA acceptance of the Biologics License Application (BLA) for HLX11, a proposed biosimilar to Genentech’s PERJETA. This marks the first U.S. BLA acceptance for a ...

Perjeta grew 17% to CHF 2.9 billion ($3.2 billion) in the first nine months of 2020, now just fractionally behind Herceptin which declined 31% to CHF 3.1 billion in the same period as biosimilars ...

Darzalex & Darzalex Faspro are indicated for the treatment of multiple myeloma. Southeastern Grocer's president and CEO and C&S Wholesale Grocers have acquired Southeastern Grocers and its Winn ...

Biosimilar companies are poised to launch cheaper ... In the UK, intravenous trastuzumab is used mainly as part of the combination with Perjeta and chemotherapy in breast cancer, and in metastatic ...

Q4 2024 Earnings Conference Call February 13, 2025 8:30 AM ETCompany ParticipantsJennifer Halchak - VP, IRKevin Ali - ...

The new biosimilar, Celltrion’s Avtozma, was approved in both IV and subcutaneous forms to treat inflammatory conditions such as arthritis. The FDA has approved Celltrion’s similar of Genentech’s ...

Less than a decade since it secured its first FDA approval for a biosimilar, Amgen’s portfolio of the copycat drugs is growing and making strong contributions to the company’s top line.

As biosimilar versions of a big-selling Johnson & Johnson medicine reach the U.S. market, the health care giant accused one manufacturer of striking a “surreptitious” deal that could arguably ...