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 […]
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 […]
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 10, 2015
State Update As states are beginning their legislative sessions for the year, there are many biosimilar bills that have been introduced. ASBM supports legislation that encourages open communication between physicians and pharmacists where physicians know exactly which product is dispensed to patients. We applaud the many states that are including this important provision and […]
February 4, 2015
On February 2, ASBM sent a letter to New Jersey Assemblywoman Pamela Lampitt supporting A2477, the bill she sponsored. Read the letter here.
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 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 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, […]
