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 […]

Read More


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 […]

Read More


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 […]

Read More


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 […]

Read More


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 […]

Read More


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 […]

Read More


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 […]

Read More


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 […]

Read More


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 […]

Read More


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, […]

Read More