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

January 17th, 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 in Switzerland.

But Hillard, now 63 years old, lucked out. Around the same time he received his diagnosis, a breast cancer drug called Herceptin was approved to treat some forms of stomach cancer. For more than four years, a Herceptin infusion taken once every three weeks has kept Hillard alive – at a cost of $1 million, he estimates, with about $100,000 coming from his own pocket.

“I can barely afford that, and I’m a doctor,” he said.

So the vote that Hillard cast on a Food and Drug Administration panel earlier this month had some extra significance. Meeting at the FDA’s Silver Spring campus, the panel recommended the approval of the first in a new class of drugs called “biosimilars” – a type of generic drug that’s never before been available in the United States and would potentially save him and patients like him thousands of dollars.

Read full article here.

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

January 14th, 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 in health care that pharmacists have used to avoid look-alike, sound-alike drug names, so the industry’s been asked to change drug names so there aren’t those kinds of mix-ups,” said Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and a member of the international advisory board to the Alliance for Safe Biologic Medicines. “Once a decision is made, it should be very clear what drug the patient’s receiving.”

Read the full article here.


Videos Explaining the Biologics and Biosimilars

January 13th, 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.

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

January 13th, 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 mention of a guidance specifically on the naming issue.

Read the full article here.

Washington Post: The cheaper cancer drug that could pave the way for much more affordable medicine

January 8th, 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 imitator of a popular medicine called Neupogen, used to help cancer patients fight off infection while undergoing chemotherapy. The FDA usually accepts recommendations from advisory panels but is not required to.

Read the article here.


Advocating for Patient Safety at FDA Hearing on Biosimilars

January 7th, 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 meeting he said the following:

“Fundamentally, patients want to know that we can expect the same safety, purity, quality and efficacy from an FDA-approved biosimilar that we can from its FDA-approved reference biologic. That level of confidence can only come through data which demonstrates therapeutic equivalence over time. That means observing the effects of these medicines in larger populations, through clinical trials and post-market surveillance.

“Another key to effective pharmacovigilance would be for the FDA to require any approved biosimilar to have a nonproprietary name distinguishable both from its reference biologic, as well as from other approved biosimilars. This will allow for physicians, pharmacists to know exactly which medicine their patient is receiving, ensure accurate attribution and tracking of adverse events, hold manufacturers accountable for the safety of their products, and help all of us better understand how these medicines work. ”

View his full testimony here.


ASBM in FDA Week

January 6th, 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.


FDA Releases List of Upcoming Biosimilar Guidances for 2015

January 6th, 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, labeling requirements for biosimilars and how interchangeability will be determined.

The titles of the forthcoming biosimilarity guidances will be as follows:

  1. Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA)
  2. Considerations in Demonstrating Interchangeability to a Reference Product
  3. Labeling for Biosimilar Biological Products
  4. Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

The full 2015 CDER Guidance Agenda may be read here.

FDA Week: Some Doctors Push Distinct Biosimilar Names, Breaking From AMA Stance

January 3rd, 2015

From FDA Week:

A handful of specialty physician groups are siding with the innovator biologics industry in urging FDA to adopt a biosimilar naming scheme under which products have distinguishable names, pushing back against arguments made by an American Medical Association council and generic drug makers for shared International Nonproprietary Names (INNs). The groups, like innovator companies, argue that distinct names are needed to track adverse events and to protect against improper pharmacy substitution.

Read the full article here.

New Canadian Survey Released at Ottawa Workshop

December 11th, 2014

On December 10th, ASBM Executive Director Michael Reilly presented the results from a new Canadian Survey at the Subsequent Entry Biologics in Canada: Current State of the Science workshop presented by the Canadian Society for Pharmaceutical Sciences and cohosted by BIOTECanada in Ottawa. The Canadian Physician Perspectives on Subsequent Entry Biologics (SEBs) survey, is a new survey of Canadian physicians’ views of biosimilars. The goal of the survey is to provide empirical data to Health Canada and other regulators on the perspective of Canadian physicians regarding SEBs (biosimilars), particularly in regard to naming. Physicians were asked about their familiarity and understanding of SEBs, the implications of an SEB sharing a non-proprietary name with its reference innovator product, how they identify biologics in patient records and in adverse event reporting, their perspective on the importance of distinguishable naming and their attitudes on pharmacy substitution.

View the presentation here.