Posts – Page 54 – Safe Biologics

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 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 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 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 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.

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 mention of a guidance specifically on the naming issue.

Read the full article here.

December 2014 Newsletter

January 8, 2015

FDA Hosts Public Hearing on Biosimilars

On January 7, ASBM members Global Colon Cancer Association (GCCA), Global Healthy Living Foundation (GHLF) and the Alliance for Patient Access (AfPA) all testified at the FDA’s Oncologic Drugs Advisory Committee (ODAC) public hearing on biosimilars. The patient groups expressed support for the pending approval, but also outlined what was needed to continue to grow patients’ confidence in the biosimilars program.

In his testimony, Andrew Spiegel, GCCA executive director and ASBM Steering Committee member, said:

“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.”

Read his full testimony here.

ASBM Quoted in FDA Week on Biosimilars Meeting

ASBM Executive Director Michael Reilly was interviewed by FDA Week prior to the ODAC meeting on how the meeting was an important opportunity for the FDA to hear from stakeholders.

From Biosimilar Advisory Meeting May Offer Final Platform For Naming Debate:

“The advisory hearing could serve as an important platform for FDA to hear stakeholders’ input on issues such as biosimilar naming as the agency nears its possible first biosimilar approval, said Michael Reilly, executive director of the Alliance for Safe Biologic Medicines. The first approval will reveal the agency’s thinking on biosimilar naming as well as other issues surrounding the data and tests required as part of the review process, he added.”

Read more here.

FDA Releases List of Upcoming Biosimilar Guidances for 2015

On January 6, the 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.

Read more here.

Physician Groups Advocate for Unique Names

The Alliance for Patient Access and other specialty physician groups wrote a letter to the FDA on the importance of giving biosimilars unique names.

On December 26, FDA Week highlighted their position in Some Doctors Push Distinct Biosimilar Names, Breaking from AMA Stance:

“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.

“The specialty physician groups wrote to FDA Thursday (Dec. 18) that a shared name would imply interchangeability, referencing statements made by the agency in past about how INNs should not be used to ‘imply pharmacologic interchangeability of products with the same active ingredient(s).’“

Read more here.

New ASBM Canadian Survey Released at Ottawa Workshop

On December 10, ASBM Executive Director Michael Reilly presented the results from a new Canadian Survey of physicians’ views at the Subsequent Entry Biologics in Canada: Current State of the Science workshop in Ottawa. The goal of the Canadian Physician Perspectives on Subsequent Entry Biologics (SEBs) survey is to provide empirical data to Health Canada and other regulators on the perspective of Canadian physicians regarding SEBs (biosimilars), particularly for naming.

The survey included 427 prescribers made up of dermatologists, gastroenterologists, internists, oncologists, pulmonologists, neurologists, urologists, nephrologists, rheumatologists and endocrinologists. The physicians were from four provinces in Canada – Alberta, British Columbia, Ontario and Quebec.

Read more here.

ASBM to Offer Class on Biosimilars to Pharmacists

ASBM is organizing a CE class for pharmacists on the fundamentals of biologics that will be offered through the Long Island School of Pharmacy. The five-hour class “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know” will help pharmacists:

1. Discuss the basic science and manufacturing of biologic medicines.
2. List the clinical implications of the key features of biologics size, complexity, sensitivity/propensity for change that distinguish biologic medicines from chemical drugs.
3. Define biosimilars and explore how they differ from generic drugs for purposes of patient care, pharmacovigilance, and pharmacy practice.
4. Discuss key regulatory and policy considerations.

The class will be held on March 15 at the New York LaGuardia Airport Marriott.

Upcoming Conferences:

January 29-30: CBI 10th Annual Summit on Biosimilars in Alexandria, VA
February 23-25: Biosimilars and Follow-on Biologics 2015 Americas in Washington, DC
April 13-15: WHO 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland

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

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 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 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 meeting he said the following:

“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 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.

FDA Releases List of Upcoming Biosimilar Guidances for 2015

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

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

Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA)
Considerations in Demonstrating Interchangeability to a Reference Product
Labeling for Biosimilar Biological Products
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 3, 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.