In February 2012, the FDA issued three guidelines that list the requirements for biosimilar registration.The topics covered include scientific and quality considerations to demonstrate biosimilarity to a reference product and a guidance that clarifies the BPCI Act implementation.The sponsor application for...
Basel, July 1, 2024– Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has approved biosimilar Pyzchiva®* (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26...
The US Food and Drug Administration (FDA) has approved the first biosimilar for use in oncology ― the product isMvasi(bevacizumab-awwb), from Amgen. It is equivalent to the reference product,Avastin(Genetech/Roche), which was first approved in the United States in 2004. Like the reference ...
Biosimilar drugs are permitted under the Biologics Price Competition and Innovation Act of 2009, part of the Affordable Care Act signed by President Barack Obama in 2010, the FDA said. Zarxio is produced by Novartis, based in Princeton, N.J....
An up-to-date resource showing all biosimilars approved in the US as well as biosimilar applications filed with FDA, based on public records. Updated frequently, the number of biosimilars approved for marketing has risen markedly, while the biosimilars l
Loeb & Loeb Food & Drug Administration partnerJim Czaban, was quoted inPink Sheetdiscussing the FDA's recent memo describing the first interchangeable biosimilar exclusivity decision and the anticipated guidance based on these interpretations. “The memo can be seen as ...
The biosimilar regulations in the US are not complete, and a number of issues are still to be finalised. As argued by the author, whilst the FDA has issued some guidelines on the regulatory requirements to establish biosimilarity, they are not nearly as clear as the EMA's. Moreover, the...
Application Note: Comparative Analysis of Innovator and Biosimilar Monoclonal Antibodies using a Multi-Attribute Method Technical note: Performing the biopharmaceutical multi-attribute method (MAM) Blog posts Rapid Automated Peptide Mapping Quality by Design...
Poster NoteDifferentiate Minor Difference of Protein Structure in Biosimilar and Reference Products Using High-Resolution Orbitrap LC-MS/MS Poster NoteDisulfide Bond Analysis on Orbitrap Mass Spectrometry Poster NoteRapid Peptide Mapping via Automated ...
According to the company, Besremi is the only first-line treatment and next-generation interferon approved by the U.S. Food and Drug Administration to treat PV. The FDA approved the drug in November. Under the new guidelines, the NCCN recommends using Besremi for high- and low-risk PV patie...