Following their Senate Finance Committee hearing in February, all seven biopharmaceutical CEOs have now offered hundreds of pages of written responses to more specific questions. The lackluster ...
Interchangeable biosimilars are headed to the US market over the next several years and discussion of the incoming products kicked off both the Biosimilars Council's conference on Wednesday and RAPS' ...
Biologics have revolutionized the management of immune-mediated inflammatory diseases (IMIDs). Biosimilars are biologics that exhibit no significant differences in safety or efficacy compared with ...
In the continuing debate over the uptake of biosimilars, FDA recently put a stake in the ground by recommending in a new labeling guidance that all biosimilar products contain only a biosimilarity ...
As Humira biosimilars enter the market, patient education about biosimilars is crucial to prevent the nocebo effect when patients switch from the reference product, explained Laura Wingate, executive ...
Biosimilars are near-identical versions of biologic cancer drugs, available at lower costs. Germany saves hundreds of millions annually from just one biosimilar drug. Patient mistrust and policy ...
Biosimilars are gaining traction as competitors aim to capture market share from branded biologics such as Humira and Neulasta. Humira now faces competition from seven biosimilars, while Neulasta has ...
Forbes contributors publish independent expert analyses and insights. Joshua Cohen is a Boston-based writer who covers health policy. Biosimilars are gradually making inroads in the outpatient drug ...
Biologics are complex, high-value drugs used in autoimmunity and oncology for their precision in targeting specific immune pathways. Unlike traditional chemically synthesized drugs, biologics are ...
Campaign provides needed, fact-based, information for patients, healthcare providers and Canadians about biosimilar medicines in Canada. The Biosimilars Generation seeks to increase awareness on the ...
The U.S. Food and Drug Administration’s (FDA) new draft guidance may reduce the cost and time to market for some applicants with biosimilar Biologic License Applications (BLAs). This draft guidance ...