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:

“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 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:

  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 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.

New Canadian Survey Released at Ottawa Workshop

December 11, 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.

 

November 2014 Newsletter

December 8, 2014

Survey Presentation at Spanish Ministry of Health

On November 25, Executive Director Michael Reilly presented the European Survey results at the “1st EuropaBio – ASEBIO Meeting on Innovation and Biological Therapies” at the Spanish Ministry of Health, Social Services and Equality in Madrid. The event was hosted by EuropaBio and the Spanish Bioindustry Association (ASEBIO) and was the first time specific Spanish responses and data were presented and compared to responses from physicians in the other countries surveyed. 

Mr. Reilly pointed out that while Spanish physicians have a better understanding of biologics and biosimilars than their European counterparts, only 28% of Spanish physicians are “very familiar” with biosimilars and almost a quarter of Spanish physicians surveyed – 23% – could not define or had not heard about biosimilars before. Additionally, physicians in Spain overwhelmingly indicated that they should have the sole authority to decide the most suitable biologic medicine for their patients with 88% agreeing that they alone should be the decision-maker.

The meeting included regulators from the Spanish Ministry of Health, physicians from Spanish oncology and rheumatology societies, representatives from a hospital pharmacist organization and patient groups.

Read the press release here.

DIA Biosimilars Conference in Berlin 

On December 2, ASBM Executive Director Michael Reilly presented results from the European Survey at the DIA Biosimilars Conference held in Berlin, Germany. The conference focused on current regulatory, scientific and market access perspectives for biosimilars. ASBM provided a physician’s perspective on biosimilars on the “Health Care Professionals’ and Patients’ Perception, Understanding and Experience of the Biosimilar Concept” panel. 

Read more here.

Dr. Gewanter Responds to Hill Op-Ed

On November 18, Dr. Gewanter responded to an Op-Ed in The Hill by Tom Schatz, president of Citizens Against Government Waste, by pointing out that biosimilars were wrongly categorized in his piece as a trade/competition issue when it is really a patient safety issue.

Dr. Gewanter wrote the following statement:

“But Mr. Schatz makes a common error in equating biologic medicines with chemical medicines.  Unlike generic copies of chemical medicines, the complexity of biologics means that an attempted copy will never be identical. A biologic produced from a different cell line can, at most, be ‘similar,’ hence the term ‘biosimilars.’ This scientific reality is why biologics cannot simply be treated as generics by regulators.  Even minor differences can create adverse impact in patients, including unwanted immune responses. How similar is ‘similar enough’ to safeguard patient safety? The Food and Drug Administration (FDA) has wisely taken its time in drafting approval criteria and other guidance to answer that question accurately.”

Read more here.

Rep. Bobby Rush Op-Ed in Huffington Post

On November 6, Rep. Bobby Rush (D-Ill.) penned an Op-Ed for the Huffington Post on his concerns for ensuring safety as biosimilars are approved in the U.S. 

In Biosimilars – Another Untold Story of the Affordable Care Act he says:

There is “an earnest debate, currently taking place both in Washington, DC and in state capitals across the country, about how laws governing pharmacy practices can be updated to expand access to these drugs. While the nuances of the legislation and rules considered in each state may vary, one underlying issue has been raised in every state discussion thus far: the need to ensure active pharmacist-prescriber communications when it comes to dispensed biologics and biosimilars.

“Prescribing physicians need to know which biologic has been dispensed to support patient care in the event that a patient has an adverse response and has received multiple biologics. This is relevant not only to retail dispensed biological products, where a pharmacist and physician may not normally communicate about the history of a patient’s medicines, but also to mail-order prescriptions where the occurrence of pharmacist and prescriber communication is even less likely to take place.”

Read more here.

GaBI Newsletter Features ASBM WHO Presentation 

On November 11, ASBM was highlighted in the Generics and Biosimilars Initiative (GaBI) newsletter for presenting on naming at the WHO 59th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. 

From More Discussion on WHO Biological Qualifier:

“During the meeting, which took place from 14–16 October 2014, the Alliance for Safe Biologic Medicines (ASBM) gave a presentation on ‘Global biosimilar naming standards: physician (and patient) perspectives’ in support of the WHO’s draft biological qualifier (BQ) proposal.

“The WHO BQ proposal would assign a four-letter alphabetic code to all biologicals [1]. The ASBM, which represents healthcare, patient and physician groups, as well as originator biologicals companies, believes that the WHO’s BQ will prioritize patient safety. In September 2014, the ASBM and 14 of its member groups submitted comments to WHO supporting the BQ proposal because it ensures clear product identification and promotes manufacturer accountability.”

Read the article here.

Medscape Interview with Dr. Margaret Hamburg

Eric Topol, Editor-in-Chief of Medscape, sat down with Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration (FDA), as part of the Medscape series on the most interesting people in medicine. In the interview “FDA’s Hamburg on Balancing the Risks, Benefits for 310M Patients” Dr. Hamburg addresses biosimilars.

Watch the interview here.

EMA Revises Biosimilars Guideline

In October, the European Medicines Agency (EMA) published a revised version of its 2005 overarching biosimilars guidelines that contains new recommendations on how to bring biosimilars to market in Europe. 

Read more here.

Upcoming Conferences:

  • December 10: Subsequent Entry Biologics (SEBs) in Canada – Current State of the Science in Ottawa, ON

  • 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  

 

ASBM Presents in Berlin at DIA Conference

December 7, 2014

On December 2, Executive Director Michael Reilly presented the results from the European physicians survey at the DIA Biosimilars Conference in Berlin, Germany. The conference focused on current regulatory, scientific and market access perspectives for biosimilars and ASBM provided a physician’s perspective on biosimilars on the “Health Care Professionals’ and Patients’ Perception, Understanding and Experience of the Biosimilar Concept” panel. The German-specific responses had not been uniquely presented this way until the conference.

In his presentation, Mr. Reilly pointed out:

  • Only 39% of German physicians responded that they are very familiar with biologic medicines, and only 21% responded they are very familiar with biosimilars.
  • 68% surveyed said that if two medicines have the same non-proprietary scientific name, that it suggests or implies that the medicines are structurally identical.
  • 40% identify a biologic medicine for prescription or recording in a patient record by identifying the medicine by brand name.
  • 62% said it would not be acceptable for a pharmacist to determine which biologic (innovator or biosimilar) to dispense to their patient on initiation of treatment.

The ASBM survey, conducted at the end of 2013, is the first of its kind in Europe. Over 470 nephrologists, rheumatologists, dermatologists, neurologists, endocrinologists, and oncologists from Italy, Spain, France, Germany and the U.K. were surveyed to learn more about their views and understanding of biosimilars. The DIA Conference was the first time German specific data was singled out and compared to the responses of physicians in the four other countries.

View the presentation here.

ASBM Presents in Berlin at DIA Conference

December 7, 2014

On December 2, Executive Director Michael Reilly presented the results from the European physicians survey at the DIA Biosimilars Conference in Berlin, Germany. The conference focused on current regulatory, scientific and market access perspectives for biosimilars and ASBM provided a physician’s perspective on biosimilars on the “Health Care Professionals’ and Patients’ Perception, Understanding and Experience of the Biosimilar Concept” panel. The German-specific responses had not been uniquely presented this way until the conference.

In his presentation, Mr. Reilly pointed out:

  • Only 39% of German physicians responded that they are very familiar with biologic medicines, and only 21% responded they are very familiar with biosimilars.
  • 68% surveyed said that if two medicines have the same non-proprietary scientific name, that it suggests or implies that the medicines are structurally identical.
  • 40% identify a biologic medicine for prescription or recording in a patient record by identifying the medicine by brand name.
  • 62% said it would not be acceptable for a pharmacist to determine which biologic (innovator or biosimilar) to dispense to their patient on initiation of treatment.

The ASBM survey, conducted at the end of 2013, is the first of its kind in Europe. Over 470 nephrologists, rheumatologists, dermatologists, neurologists, endocrinologists, and oncologists from Italy, Spain, France, Germany and the U.K. were surveyed to learn more about their views and understanding of biosimilars. The DIA Conference was the first time German specific data was singled out and compared to the responses of physicians in the four other countries.

View the presentation here.

ASBM Presents European Physicians Survey at Spanish Ministry of Health

November 26, 2014

On November 25 in Madrid, Spain, the Alliance for Safe Biologic Medicines presented results from a survey of European physicians at the “1ST EuropaBio – ASEBIO Meeting on Innovation and Biological Therapies” at the Spanish Ministry of Health, Social Services and Equality. The event, hosted by EuropaBio and the Spanish Bioindustry Association (ASEBIO), included regulators from the Spanish Ministry of Health, physicians from Spanish oncology and rheumatology societies, representatives from a hospital pharmacist organization and patient groups.

ASBM Executive Director Michael Reilly shared the results of the E.U. physicians survey conducted at the end of 2013, and also for the first time shared the specific responses from the Spanish physicians who were included in the survey.  The ASBM survey is the first of its kind in Europe and provided valuable data on physicians’ views and understanding of biosimilar medicines.  Over 470 nephrologists, rheumatologists, dermatologists, neurologists, endocrinologists, and oncologists from the big 5 western European countries that also included France, Germany, Italy and the U.K.

michael-spain1“Physicians in Spain and across Europe have a solid understanding of biologic medicines, however, there is a clear need for further education when it comes to biosimilars,” said Reilly in his presentation. “The Spain data as well as the data from the larger survey make it clear that physician misconceptions about biosimilars and the prescribing practices they utilize, indicates a strong need for a clear naming scheme with distinguishable non-proprietary names for all biologics.”

michael-spain-crowdIn the presentation, Reilly pointed out while Spanish physicians have a better understanding of biologics and biosimilars than their European counterparts, only 28% of Spanish physicians are “very familiar” with biosimilars.  In addition, almost a quarter of Spanish physicians surveyed – 23% – could not define or had not heard about biosimilars before.

Physicians in Spain overwhelmingly indicated that they should have the sole authority to decide the most suitable biologic medicine for their patients with 88% agreeing that they alone should be the decision-maker compared to 68% of survey respondents from France, Germany, Italy and the U.K.  Additionally, Spanish respondents strongly believed that they should be notified if a pharmacist dispensed a biologic other than the one they prescribed – 92% said it is very important or critical that they be notified – compared to the 54% average of the other European countries surveyed.

View Mr. Reilly’s presentation here.

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