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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.


ASBM Presents European Physicians Survey at Spanish Ministry of Health

November 26th, 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.

Dr. Gewanter Responds to CAGW Op-Ed

November 21st, 2014

On November 18, Dr. Gewanter responded to a piece in The Hill by Citizens Against Government Waste, by pointing out that the author Tom Schatz, wrongly categorized biosimilar approval as a trade/competition issue when it is a really a patient safety issue.

In his letter Dr. Gewanter wrote:

As a practicing pediatric rheumatologist and chairman of the Alliance for Safe Biologic Medicines, I wish to correct some misinformation published in your Nov. 11 article, (“Biosimilar approval is long overdue”, by Tom Schatz.) Biologic medicines have helped millions of patients suffering from cancer, rheumatoid arthritis, and other conditions, and the author is correct in his basic assertion that biosimilars- attempts to replicate them- will offer patients new ways to access versions of these therapies.

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.

Requiring biosimilars to be distinguishable not only from the biologic they aim to replicate, but also from other biosimilars, is smart for everyone: patients and physicians know which medicine they are receiving. Pharmacists can avoid inadvertent or inappropriate substitution. Regulators can better track adverse events and efficacy of products.  Manufacturers will learn more, and be more accountable for their products.

Since the use and manufacture of biologics is global, the need for distinguishable naming is global. This is why the World Health Organization has proposed a global solution- adding a four letter “biological qualifier” (BQ) to the International Nonproprietary Name (INN) of each biosimilar. All patients deserve these protections, regardless of in which country they receive treatment.

Mr. Schatz claims the WHO’s proposal will “confuse providers and users”. To the contrary, it will add much-needed clarity:

A 2013 survey by ASBM of 470 European physicians showed that 24% use only the INN when prescribing, potentially resulting in patients receiving the wrong medicine. When reporting adverse events, 17% use only the INN, potentially resulting in false attribution of adverse events. Europe’s solution has been to track adverse events by batch number, yet only 40% of its physicians use these consistently, while 27% never use them.

More than 30 biosimilars are now available in Thailand to stimulate red blood cell production in cancer patients. One (or more) caused a deadly condition known as Pure Red Cell Aplasia (PRCA). Since all share the same INN, being able to attribute adverse effects – and efficacy – is critical.

Distinguishability isn’t confusing for doctors and patients; ambiguity is.

This is why ASBM joined more than 50 patient and professional organizations, by signing a letter in August urging FDA to follow the WHO’s lead and support distinguishable names for biosimilars.

When balancing potential cost savings, access to care, or administrative speed, against patient safety- patient safety must always trump all other concerns.






Medscape Interview with FDA Commissioner Dr. Margaret Hamburg

November 13th, 2014

On November 12th Medscape posted an interesting video interview with FDA Commissioner Dr. Margaret Hamburg.

Watch “FDA’s Hamburg on Balancing the Risks, Benefits for 310M Patientshere.

Rep. Bobby Rush OpEd in Huffington Post

November 10th, 2014

Rep. Bobby Rush: “Biosimilars – Another Untold Story of the Affordable Care Act”

In a November 6, oped for the Huffington Post, Rep. Bobby Rush (D-Ill) made the case for physician- pharmacist communication when it comes dispensing biosimilars. He wrote:

“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 the full piece here.

ASBM presents at the 15th Annual Business of Biosimilars Conference in Boston

November 5th, 2014

BOSTON, Massachusetts- On October 20-22, 2014, ASBM members John Lewis and Andrew Spiegel attended the 15th Annual Business of Biosimilars Conference held at the Omni Park Hotel in Boston.

On day one of the conference, John Lewis from ACRO moderated a panel titled “Looking at the Commercial Realities of the Biosimilar Market”. Topics discussed included how many companies the market can truly bear, what is it going to take to be successful after overcoming the hurdles of development, accounting for the patient/provider/payer perspectives, and educated attendees on how to make choices about the next MaBs in pipeline. Panelists included: Carsten Brockmeyer, CEO, Formycon AG; Mohammed Ladha, Global Biologics Marketing, Hospira, and Yariv Hefez; Vice President Business Development, Portfolio Management Strategy and Partnering, Biosimilars Unit, Merck Serono.

SpiegelBostonOn the 2nd day of the conference, Andrew Spiegel from the Global Colon Cancer Association joined an expert panel including Bruce A. Leicher, Senior Vice President and General Counsel, Momenta Pharmaceuticals, Inc. and Michael Malecki, Director, (Biosimilars) Research and Development Policy, Amgen.  The panel focused on Biosimilar policies and adoption.  Issues discussed included an update on State substitution laws & interchangeability, naming and whether data, reimbursement, cost, payor controls or other factors will drive the adoption of Biosimilars.

ASBM European Survey Presented to Italian Ministry of Health

October 23rd, 2014

Launches discussion about the future of biosimilars in Italy

Results from a survey of 470 European physicians conducted by the Alliance for Safe Biologic Medicines (ASBM) set the stage for a stakeholder meeting at the Italian Ministry of Health to discuss the future of biosimilars policy in Italy. The October 20th event, titled “Biosimilars in Clinical Practice: Does Italy Need to Act” included regulators from the Italian Medicines Agency (AIFA), physicians from that country’s nephrology and dermatology societies, representatives from a hospital pharmacist organization, patient activists, and the Italian biotechnology trade association.

ASBM Executive Director Michael Reilly for the first time revealed the Italian responses from the ASBM survey that had previously been the subject of a whitepaper in the Journal of the Generics and Biosimilars Initiative, available here.

“The perspectives of those most familiar with the clinical use of biologic and biosimilar medicines – Italy’s physicians – offer invaluable guidance to its regulators as they craft biosimilar policy for Italy’s physicians, pharmacists and patients,” said Reilly.

The data demonstrated that physicians in Italy have a better understanding of biologics and biosimilars than physicians from the other four European countries surveyed (i.e., France, Germany, Spain and the U.K.) but also makes it clear that there remains a strong need for additional education and information on biosimilars among Italian physicians. For example, only 26% of Italian physicians considered themselves “very familiar” with biosimilars while 17% could not define or had not heard about biosimilars before.

A major topic of discussion was clarity in the naming of biologic medicines. Due to the extreme complexity of biologics, even the smallest difference between the structure of an innovator biologic and an attempted copy can have a significant impact on a patient, including adverse events such as unwanted immune responses. Yet when reporting adverse events, 22% of physicians record only the INN, which may lead to false attribution. Additionally, 25% of physicians use only the international non-proprietary name, or INN, when prescribing biologics, which may lead to patients receiving the wrong medicine from a pharmacist.

“The prescribing practices of Europe’s physicians demonstrate biosimilars must have the additional safeguard of distinguishable names to ensure clear prescribing and monitoring,” Reilly explained. “Distinguishable naming promotes accurate identification by physicians and pharmacists, helps regulators accurately track and understand these medicines, and promotes manufacturer accountability.”

View Mr. Reilly’s presentation here.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326

GaBI Article: IAPO releases toolkit for biologicals and biosimilars

October 20th, 2014

The Generics and Biosimilars Initiative (GaBI) recently published an article on IAPO’s Advocacy Toolkit on Biological and Biosimilar Medicines for Patients’ Organizations:

The International Alliance of Patients’ Organizations (IAPO), which comprises over 200 patient groups and represents the interests of patients worldwide, has published an Information and Advocacy Toolkit on Biological and Biosimilar Medicines for Patients’ Organizations. The Toolkit, published in November 2013, provides up-to-date, evidence-based information on the science, technology and regulatory information relevant to biologicals and biosimilars.

Read the article here.

ASBM Presents at WHO Meeting on Naming

October 17th, 2014

Introduces Chairman Gewanter, shows support for BQ proposal

Geneva – The Alliance for Safe Biologic Medicines (ASBM) presented at the World Health Organization’s (WHO) 59th International Nonproprietary Naming Stakeholders Session on Tuesday, October 14, 2014. This was the third time ASBM presented to the WHO but the first appearance for ASBM’s new chairman Dr. Harry L. Gewanter.

As a practicing pediatric rheumatologist and ASBM International Advisory Board (IAB) member, Harry L. Gewanter, MD, FAAP, FACR has been integrally involved in developing policy recommendations involving biosimilars that are patient-focused and physician friendly.

During his presentation “Global Biosimilar Naming Standards: Physician (and Patient) Perspectives” Dr. Gewanter thanked the WHO for the opportunity to present and for its efforts to prioritize patient safety.

At the request of the WHO, the proceedings of the stakeholder session are to remain confidential until the esteemed body has an opportunity to hold a closed session to discuss the “Biological Qualifier” proposal that was released in August.

ASBM has been very supportive of the WHO’s draft BQ proposal that would assign a four-letter alphabetic code to all biologics. In September, ASBM and 14 of its member groups submitted comments to the WHO supporting the BQ proposal because it ensures clear product identification and promotes manufacturer accountability.

In the U.S., ASBM has encouraged the FDA to follow the WHO’s lead. In August, ASBM and over 70 patient organizations wrote a letter encouraging the FDA to adopt a policy of distinguishable nonproprietary names for biosimilars and to issue guidance reflecting distinguishable naming in a timely manner as the first application for a biosimilar has been accepted.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326

Biosimilars Discussed on BioCentury This Week

October 14th, 2014

On October 12, BioCentury This Week did a special on FDA’s thinking about interchangeability, naming and other questions surrounding biosimilars with Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

The show also featured Dr. Mark McCamish, global head of biopharmaceutical development at the Sandoz unit of Novartis, and Geoffrey Eich, executive director for external affairs at Amgen Biosimilars, who discussed commercial and regulatory strategies for biosimilars.

Watch BioCentury’s “Preparing for Biosimilars” here.