Biologics are medicines that are made from living organisms through highly complex manufacturing processes and include a wide variety of medicines such as therapeutic proteins, monoclonal antibodies...
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IP Explained: Why IP protections are important for biologic medicines

Biologics are cutting-edge therapies that treat or cure some of the most challenging and costly diseases. These medicines are created from living organisms through highly complex manufacturing...
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Balancing innovation and competition in the biologics marketplace

Last month, I presented at the U.S. Food and Drug Administration’s (FDA) Public Hearing on Facilitating Competition and Innovation in the Biological Products Marketplace. The hearing was part of an...
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Spending on medicines grew less than one percent in 2017

Last year, a record number of new treatments and cures that are transforming care for patients fighting debilitating diseases like cancer, hepatitis C, high cholesterol and more were approved by the...
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Medicare Monday: Billing code basics for biologics in Part B

We’ve explored the Centers for Medicare & Medicaid Services’ (CMS) flawed policy for reimbursing biologic and biosimilar products before. Today, we’re exploring how proposals from MedPAC would build...
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FDA issues draft biosimilars labeling guidance

Labeling is an important aspect of the U.S. Food and Drug Administration (FDA) prescription drug approval process. FDA-approved prescription drug labeling is the most authoritative mechanism for...
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The biopharmaceutical industry’s commitment to quality

America’s innovative biopharmaceutical companies are leaders in innovation and quality—not just in research and development, but also in manufacturing technology. PhRMA’s member companies implement...
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PhRMA and BIO Citizen Petition to FDA calls for biosimilar labeling guidance

Biosimilars will continue to become more widely available to patients in 2016 and beyond. PhRMA supports science-based regulation of biosimilars by the Food and Drug Administration (FDA). However,...
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PhRMA launches biologics and biosimilars online resources

Biological medicines often represent the cutting-edge of biomedical research and have revolutionized the treatment of a variety of medical illnesses and conditions that presently have no other...
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Medicare Monday: Part B and biosimilars, part 2

Earlier this month, Medicare Monday covered the Center for Medicare & Medicaid Services (CMS) final rule on reimbursement for biosimilars and the implications of using a single billing code to...
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