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FDA issues draft biosimilars labeling guidance

By Andrew Powaleny  |    April 12, 2016
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...   Read More

The biopharmaceutical industry’s commitment to quality

By Camille Jackson  |    February 11, 2016
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...   Read More

PhRMA and BIO Citizen Petition to FDA calls for biosimilar labeling guidance

By Jeff Francer  |    January 21, 2016
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)....   Read More

PhRMA launches biologics and biosimilars online resources

By Andrew Powaleny  |    December 17, 2015
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...   Read More

Medicare Monday: Part B and biosimilars, part 2

By Kelsey Lang  |    November 30, 2015
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...   Read More

Medicare Monday: Medicare Part B and biosimilars

By Andrew Powaleny  |    November 16, 2015
With the first U.S. biosimilar approved in March of 2015, the pathway created by the Biologics Price Competition and Innovation Act to bring biosimilars to market for U.S. patients has become a...   Read More

ICYMI: Wall Street Journal and Washington Post Say TPP Should Protect Medical Innovation

By Tina Stow  |    August 11, 2015
In case you missed it, The Wall Street Journal and The Washington Post editorialized yesterday on the Trans-Pacific Partnership (TPP) and the importance of reaching a trade deal that protects U.S....   Read More

Maintaining Appropriate Incentives for Biopharmaceutical Innovation

By Anne McDonald Pritchett, PhD  |    February 4, 2015
As we enter the second half of the decade, the biopharmaceutical industry’s approach to research and development (R&D) continues to evolve to meet the growing demand for new medicines. New...   Read More

Breaking a Link in the Value Chain

By PhRMA Staff  |    February 22, 2011
Over the weekend, The Boston Globe ran an article that included a turn of phrase that I thought was a keeper: "the whole value chain of innovation."   Read More

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