The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new ‘cluster’ on biosimilar medicines.  Clusters are topic areas of mutual interest for the two agencies, which they have identified as benefiting from the regular exchange of information and collaborative meetings. Biosimilar medicines is the latest addition […]

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By Brian Gormley Wall Street Journal U.S. pharmaceutical companies have long lived with generic rivals, and soon biotechnology concerns will face similar competition. Through the health-care reform law passed last year, Congress created a regulatory path for companies to introduce “biosimilars,” or nearly exact copies of biological drugs that have come off patent. Read More

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By Jorgo Chatzimarkakis, PhD, member of European Parliament The Health Care Blog Around the world and now in the United States, there is a broadening discussion of how best to proceed down the path of approving and getting to market medicines called biosimilars. Biosimilars are non-identical copies of next generation medicines known as biologics. As […]

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By Jorgo Chatzimarkakis, PhD, member of European Parliament The Health Care Blog Around the world and now in the United States, there is a broadening discussion of how best to proceed down the path of approving and getting to market medicines called biosimilars. Biosimilars are non-identical copies of next generation medicines known as biologics. As […]

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By Andre Williams, Association of Black Cardiologists Politic365.com President Barack Obama recently indicated his interest in improving the Food and Drug Administration’s (FDA) approval process for new medical devices, saying the agency could “keep patients safer while getting innovative and life-saving products to market faster.” Read More

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By Andre Williams, Association of Black Cardiologists Politic365.com President Barack Obama recently indicated his interest in improving the Food and Drug Administration’s (FDA) approval process for new medical devices, saying the agency could “keep patients safer while getting innovative and life-saving products to market faster.” Read More

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Drugmakers seeking U.S. approval for the first lower-cost copies of biologic medicines made from living cells should initially pay application fees similar to charges for brand-name medicines, regulators said. Read More

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Dr. Marcy L. Zwelling-Aamot Sacramento Bee When it comes to biologics, is biosimilar good enough? There is a new development in pharmaceuticals. It is a class of drugs called biologics. They are not only new; they are each unique. Read More

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William P. Bro, Kidney Cancer Association At the Kidney Cancer foundation we’re constantly seeking new ways to ensure those with cancer have access to the best medical data and medicines possible. For the past 20 years, we have served as a source of support and information for individuals and their loved ones affected by kidney […]

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