Safe Biologics

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

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 the U.S. begins establishing new guidance for biosimilars, regulators and legislators should look to the European Union model on guidance policy and approve these important, often life-saving, drugs when they are proven to be safe for the patients they are intended to heal. Read More

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 the U.S. begins establishing new guidance for biosimilars, regulators and legislators should look to the European Union model on guidance policy and approve these important, often life-saving, drugs when they are proven to be safe for the patients they are intended to heal. Read More

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

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

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

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