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Recent Legislation a Boost for Biosimilars?

Biosimilars, also known as “follow on biologics,” are copies of currently marketed biopharmaceuticals. After a biopharmaceutical’s patent protection and exclusivity has expired, other companies can...

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The Future of Biogenerics

In March 2010, when President Obama signed into law the Affordable Care Act he cleared the way for the Food and Drug Administration (FDA) to approve biogenerics. Before this there was no pathway for a...

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Can Biogenerics Deliver on the Multibillion-Dollar Market Promise?

Biogenerics have received a lot of publicity regarding the estimated multibillion-dollar market they represent and the discussion has the attention of several companies not involved in the health care...

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What’s Next for Biosimilars?

The future of biosimilars in the United States is yet to be determined. The Food and Drug Administration (FDA) has not settled on a regulatory pathway for approval (expected by the end of 2011) and a...

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Amgen, Biogen Idec, and Baxter Invest in Biogenerics Industry Despite Lack of...

The Affordable Care Act was approved in 2010 with the goal of reducing healthcare costs. The Act’s main function was to clear the way for the Food and Drug Administration (FDA) to create an approval...

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FDA Issues Biosimilar Approval Guidelines

The Affordable Care Act was approved in 2010 with the goal of reducing healthcare costs. The Act’s main function was to clear the way for the Food and Drug Administration (FDA) to create an approval...

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Comments on Biosimilar Guidance Indicate Discontent on Both Sides of the Issues

The Affordable Care Act was approved in 2010 with the goal of reducing healthcare costs. The Act’s main function was to clear the way for the Food and Drug Administration (FDA) to create an approval...

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Supreme Court Upholds Affordable Care Act – What It Means for Healthcare

Last week, the Supreme Court ruled in favor of upholding President Obama’s Affordable Care Act. The Affordable Care Act originally approved in 2010, with the goal of overhauling the healthcare system,...

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Biologics Have a Robust Pipeline According to Latest PhRMA Report

Earlier this month, the Pharmaceutical Research and Manufacturers of America released a new report “Medicines in Development – Biologics, 2013 Report.” The report lists 907 biologics currently in...

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Stem Cell Therapy Indications for Neurological Disorders in Phase II Clinical...

Stem cell therapies are being developed for several different indications. In April we reviewed stem cell therapy indications for cardiovascular disease that are in Phase II/III clinical trials....

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