The Jersey Journal: Making sure new medicines are safe

March 9, 2015

Most of the pills and injectable medications you take today are made from inert materials in a lab somewhere, but the stuff you may take next year could be made from body cells or plants.  They work really well. Perhaps they’ll even cure your problem, but currently they are very expensive. You’ve heard about them […]

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The Jersey Journal: Making sure new medicines are safe

March 9, 2015

Most of the pills and injectable medications you take today are made from inert materials in a lab somewhere, but the stuff you may take next year could be made from body cells or plants.  They work really well. Perhaps they’ll even cure your problem, but currently they are very expensive. You’ve heard about them […]

Read More


FDA approves first biosimilar product Zarxio

March 6, 2015

The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar product is a biological product that is approved based on a showing that […]

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FDA approves first biosimilar product Zarxio

March 6, 2015

The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar product is a biological product that is approved based on a showing that […]

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NJ Spotlight: Legislature Grapples with How to Regulate Biologics, New Class of Medication

February 12, 2015

Measure would require pharmacists to inform doctors when they use new drugs, as well as generic ‘biosimilars’ Andrew Kitchenman In recent years, many of the bestselling new medications haven’t been traditional drugs chemically synthesized in labs. Instead, they belong to a growing class of “biologics” — substances that are cultivated from living cells, often by […]

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NJ Spotlight: Legislature Grapples with How to Regulate Biologics, New Class of Medication

February 12, 2015

Measure would require pharmacists to inform doctors when they use new drugs, as well as generic ‘biosimilars’ Andrew Kitchenman In recent years, many of the bestselling new medications haven’t been traditional drugs chemically synthesized in labs. Instead, they belong to a growing class of “biologics” — substances that are cultivated from living cells, often by […]

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Washington Post: The coming revolution in much cheaper life-saving drugs

January 17, 2015

Randy Hillard was supposed to be dead by now. In 2010, the Michigan State University psychiatry professor was diagnosed with stage four stomach cancer and given less than a year to live. He started wondering how he could die in the most comfortable way possible given the circumstances, even briefly researching an assisted suicide organization […]

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Pharmacy Today: Pharmacists and health systems prepare to add biosimilars to formularies

January 14, 2015

The American Pharmacists Association publication, Pharmacy Today, featured an article on biosimilars and quoted Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and ASBM  international advisory board member. In the article he said: “Even if a drug is considered similar, it should be easily identified. There’s been a longstanding principle […]

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Videos Explaining the Biologics and Biosimilars

January 13, 2015

Amgen Canada has created two new videos explaining the differences between biologics and biosimilars. The videos show why manufacturing really matters and the importance of patient safety as biosimilars are approved. Watch the videos here.

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Inside Health Policy: FDA Guidance Agenda Doesn’t List Biosimilar Naming, But Includes Labeling

January 13, 2015

The controversial issue of biosimilar naming is seemingly absent from the FDA drug center’s 2015 guidance agenda as all signs point to the agency approving the first U.S. biosimilar by early March. The guidance agenda slates four biosimilar documents the agency plans to put out this year including one on labeling, but there is no […]

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