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' ...
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 ...
A wave of expiries will hit high-value assets, including Keytruda, Eliquis, Ibrance, and Trulicity, amplifying revenue ...
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 offer an opportunity to reduce the cost of life-changing immunomodulatory therapies. Data has highlighted how ...
There is a right way and a wrong way to inform a patient about a switch from the reference product to a biosimilar, explained Laura Wingate, executive vice president, Education, Support, & Advocacy, ...
The U.S. Food and Drug Administration’s (FDA) new draft guidance may reduce the cost and time to market for some applicants with biosimilar Biologic License Applications (BLAs). This draft guidance ...
The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...
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 ...
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