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 […]
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 […]
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 […]
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 […]
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.
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 […]
January 8, 2015
A government panel Wednesday took a major step toward approving a copycat version of a blockbuster cancer drug, paving the way for a new class of cheaper medicines that could save consumers billions of dollars. An expert Food and Drug Administration panel unanimously recommended that the government approve the drug known as EP2006, a lower-cost […]
January 7, 2015
On January 7, Andrew Spiegel, executive director of the Global Colon Cancer Association and ASBM Steering Committee member, presented before the U.S. Food and Drug Administration (FDA) providing a patient perspective on why safety must be the ultimate priority when approving biosimilars. During his oral presentation before at the FDA’s Oncologic Drugs Advisory Committee (ODAC) public […]
January 6, 2015
On December 24, FDA Week quoted ASBM Executive Director, Michael Reilly, on how the upcoming January 7th FDA Meeting on Biosimilars will be an important opportunity for the FDA to hear from stakeholders. Read the full article Biosimilar Advisory Meeting May Offer Final Platform For Naming Debate here.
January 6, 2015
On January 6, the U.S. Food and Drug Administration (FDA) released its annual Guidance Agenda detailing which new and revised Draft Guidances will be issued by its Center for Drug Evaluation and Research (CDER) for 2015. Among them are four guidances pertaining to biosimilarity. Topics covered include: what data will be allowed for demonstrating biosimilarity, […]
