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.

Biosimilars 59

Biosimilars Chemotherapy Diabetes 59

Big Molecule Watch

FEBRUARY 6, 2025

On February 2, 2025, Shanghai Henlius Biotech, Inc. 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.

Biosimilars 59

Biosimilars Chemotherapy 59

pharmaphorum

DECEMBER 21, 2020

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

Biosimilars 126

Biosimilars Chemotherapy Immunity Immunization 126

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. There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone. That litigation is ongoing.

Biosimilars 45

Biosimilars Drug Pricing Labelling Communication 45

Quality Matters

FEBRUARY 6, 2025

Because of a monoclonal antibody's ability to recognize and connect to a cancer cell, it can serve as a delivery vehicle for other treatments, such as chemotherapy and radiation. josh.levin@usp.org Thu, 02/06/2025 - 15:01 Biologics

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Immunity Immunization Biosimilars 52

European Pharmaceutical Review

FEBRUARY 3, 2025

EMAs human medicines committee (CHMP) recommended eight medicines for EU marketing authorisation at its January 2025 meeting. Biosimilars given a positive opinion Dyrupeg (pegfilgrastim) to reduce the duration of neutropenia and help prevent febrile neutropenia following chemotherapy.

Vaccines 52

Vaccines Generic Medicine Chemotherapy Biosimilars 52