Developing the Nation’s Biosimilars Program

August 4, 2011

Developing the Nation’s Biosimilars Program Steven Kozlowski, M.D., Janet Woodcock, M.D., Karen Midthun, M.D., and Rachel Behrman Sherman, M.D., M.P.H. New England Journal of Medicine August 4, 2011 Biologic products developed over the past three decades and approved by the Food and Drug Administration (FDA) now provide important therapeutic options for a variety of serious […]

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FDA gives glimpse of biosimilar approval process

August 3, 2011

Reuters By Anna Yukhananov Evaluating generic versions of complex biotechnology medicines will require a new, more rigorous review process, U.S. drug regulators said, in the first glimpse of their thinking on the subject. Drugmakers, investors and others have been clamoring for more insight into the approval process for cheaper versions of biotech drugs, known as […]

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New medicines offer hope, require caution

August 1, 2011

By Helena R. Berger, Executive Vice President & CEO, American Association of People with Disabilities Buffalo News The future of medicine is biologic drugs. Not only have they revolutionized the medical treatments of serious diseases, they have also transformed treatments for many people with disabilities – from offering new promise to people with multiple sclerosis […]

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Rethink regulations for new drug therapies

July 28, 2011

Orange County Register By Thair Phillips, President, RetireSafe The biotech revolution has brought hope to millions of Americans coping with some of the most devastating medical conditions, including cancer, Parkinson’s disease and rheumatoid arthritis. New prescription drugs, known as biologics, that were born of this revolution now comprise the fastest-growing segment of the pharmaceutical market […]

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Getting it right on biosimilars and patient safety

July 11, 2011

By John Horton, President of LegitScript Oregon Statesman Journal In just the first three days of summer, at least six unrelated pharmaceutical manufacturers you’ve probably never heard of — companies with names like Xcellerex, Avesthagen, NeuClone and Lupin — were the subject of various press releases. The content varied, but all of the news involved […]

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Patient Safety Depends on Prevention

June 29, 2011

By Andrew R. Spiegel CEO, Colon Cancer Alliance MedCity News Prevention is a key message of the Colon Cancer Alliance. Over 80% of all cases of colorectal cancer can be prevented with recommended screenings. Despite its high incidence, colorectal cancer is one of the most detectable and, if found early enough, most treatable forms of […]

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Patient Safety with Biosimilars: Not the Same, Only Similar

June 24, 2011

By Bruce S. Rubin, MD Assistant Professor of Clinical Neurology, University of Miami Miller School of Medicine Opposing Views Scientific advancements in medicine are important achievements that improve quality of life for many people.  One recent example is in the field of biotech medicines.  But in the rush to make generic versions of these drugs, […]

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European Medicines Agency and US Food and Drug Administration set up biosimilar ‘cluster’ and publish first report on interactions

June 23, 2011

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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Why Biotechs Need To Worry About Generics, Too.

June 14, 2011

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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When It Comes to Patient Safety, Caution Isn’t a Four-letter Word

May 20, 2011

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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