2024 Biosimilars Chemotherapy 
Big Molecule Watch
FEBRUARY 7, 2025
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the grant of marketing authorizationsforthree biosimilar productsAmgens PAVBLU and SKOJOY, and CuraTeQ Biologics DYRUPEG.
Big Molecule Watch
FEBRUARY 6, 2025
Henlius) announced FDA acceptance of the Biologics License Application (BLA) for HLX11, a proposed biosimilar to Genentechs PERJETA. This marks the first U.S.BLAacceptance for a pertuzumab biosimilar, a targeted therapy for select patients with HER2-positive breast cancer. On February 2, 2025, Shanghai Henlius Biotech, Inc.
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Big Molecule Watch
DECEMBER 16, 2024
On December 3, 2024, Accord BioPharma, Inc. UDENYCA , the only biosimilar to Amgens NEULASTA in the United States, is administered the day after chemotherapy treatment to decrease the incidence of infection by febrile neutropenia. Accord), the U.S. specialty division of Intas Pharmaceuticals, Ltd.
Big Molecule Watch
JANUARY 10, 2025
As 2025 begins, we would like to reflect on last years regulatory developments in the biologics and biosimilars space. Here are some of the top regulatory developments from 2024. FDA Approvals in 2024 There were 17 FDA approvals of Biologic License Applications (BLAs), including for Autolus Inc.’s
pharmaphorum
OCTOBER 10, 2022
The study showed that the combination has the potential to “provide a safer and better tolerated alternative” to the use of PD-1/PD-L1 drugs plus chemotherapy in first-line NSCLC, the current standard of treatment, according to Dr Chris Redhead of Goetz Partners. month mPFS with Keytruda plus chemo, with fewer side effects.
Safe Biologics
AUGUST 23, 2024
as in most advanced nations, a prescribing physician may substitute any biosimilar for its reference product. However, substitution of biosimilars at the pharmacy level is controversial, opposed by majorities of physicians worldwide, and banned in many countries including most of Western Europe. In the U.S. In the U.S., In the U.S.,
European Pharmaceutical Review
APRIL 30, 2024
If approved, fruquintinib could provide a new oral, chemotherapy-free option as the first and only selective inhibitor of all three vascular endothelial growth factor receptors (VEGFR) receptors approved in the EU for this disease, according to Takeda.
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