Biosimilars: US payers “will want more data than FDA”

August 5, 2011

PharmaTimes By Lynne Taylor To feel comfortable with generic biologics (biosimilars), US payers are likely to require more clinical information than what might be accepted by the Food and Drug Administration (FDA) for approvals, a new report suggests. For example, FDA approval of biosimilar versions of monoclonal antibodies (MAbs) for oncology indications will not allay […]

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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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Biosimilars Policy Forum: Ensuring Patient Safety

August 1, 2011

Alliance for Safe Biologic Medicines & Pennsylvania Bio August 17, 2011 The Quorum at the University Science Center Philadelphia, PA Read More

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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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Annual Luncheon Celebrating Women in Science

July 14, 2011

September 20, 2011 Rice Hotel Houston, TX Read More

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BioHouston Breakfast Forum

July 14, 2011

June 21, 2011 Trevisio Restaurant – 6550 Bertner Street Houston, TX Read More

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Texas Healthcare & Bioscience Institute

July 14, 2011

2011 Calendar of Events Austin, TX Read More

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July 14, 2011

BioDFW BioHouston BioMed – San Antonio Health Industry Council of North Texas Houston Technology Center San Antonio Life Sciences Association Texas A&M Health Science Center Texas Bioscience Institute Texas Department of State Health Services Texas Emerging Technology Fund Texas Healthcare & Bioscience Institute Texas House of Representatives Texas Life Science Center Texas Life Sciences Collaboration […]

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