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.

Dr. Gewanter Responds to CAGW Op-Ed

November 21, 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 13, 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 Patients” here.

Rep. Bobby Rush OpEd in Huffington Post

November 10, 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.

October 2014 Newsletter

November 8, 2014

ASBM Presents to WHO in Geneva

On October 15, ASBM Chairman Dr. Gewanter and Executive Director Michael Reilly traveled to Geneva, Switzerland to participate in the World Health Organization’s (WHO) 59th International Nonproprietary Naming Stakeholders Session.  The Geneva meeting was Dr. Gewanter’s first public appearance as ASBM Chairman, a role he assumed on September 1 following Dr. Richard Dolinar’s successful three-year term.

In his presentation, “Global Biosimilar Naming Standards: Physician (and Patient) Perspectives,”  Dr. Gewanter thanked the WHO for the leadership they have shown on naming and again expressed ASBM’s support for the Biologic Qualifier (BQ) proposal released in August that would assign a four-letter alphabetic code to all biologics.

At the request of the WHO, the stakeholder session and the specifics of Dr. Gewanter’s presentation, are to remain confidential until the WHO holds a closed session on the BQ proposal.

Read the press release here.

ASBM in Italy 

After the WHO INN meeting, ASBM Executive Director Michael Reilly traveled to Rome, Italy to participate in an event held at the Italian Ministry of Health on October 20 that was titled “Biosimilars in Clinical Practice: Does Italy Need to Act?”

In his presentation, Reilly shared the results of ASBM’s European physician survey, and focused primarily on the responses from Italian physicians. Following the presentation of survey results, there was a robust and lengthy discussion about the challenges biosimilars pose for regulators but also about the tremendous opportunities they offer patients and physicians.  Attendees included representatives from the Italian Medicines Agency (AIFA), physicians from the country’s nephrology and dermatology societies, representatives from a hospital pharmacist organization, patient activists, and the Italian biotechnology trade association.

Read more here.

Business of Biosimilars in Boston

ASBM Steering Committee members John Lewis and Andrew Spiegel participated in the “Business of Biosimilars” meeting held in Boston, October 20-22.

John Lewis moderated the “Looking at the Commercial Realities of the Biosimilar Market” panel which discussed the different challenges and pathways for biosimilar adoption, and the role of payers, regulators, physicians and patients.

Andrew Spiegel was a panelist on the “Expert Opinions: Biosimilar Policies and Adoption” which was an in-depth discussion on the policy impact adoption will have on the states, particularly around substitution and physician communication.

Read more here.

EuropaBio Publishes New Materials on Biosimilars

On October 6, EuropaBio published a new Guide and a new Position Paper on Biosimilars in Europe. Titled ”When Science Meets Policy,” the two documents were designed to provide European and national regulators, policy makers, physicians, other healthcare providers and patients with information on key issues regarding biosimilars policy and why Europe must maintain high standards for biosimilars.

Read both documents here.

GaBI Highlights IAPO’s Advocacy Toolkit

On October 3, the Generics and Biosimilars Initiative (GaBI) published an article on IAPO’s Advocacy Toolkit on Biological and Biosimilar Medicines for Patients’ Organizations. The Toolkit, which was published in November 2013, provides up-to-date, evidence-based information on the science, technology and regulatory information relevant to biologicals and biosimilars.

From “IAPO Releases Toolkit for Biologicals and Biosimilars:”

“The document follows an online consultation with IAPO members to understand the level of awareness of biologicals and biosimilars, their regulation and use, and the issues and concerns that patients’ organizations found most important. Raising patient awareness is essential, since the acceptance of generics substitution worldwide has been slow, with research showing that many patients get confused or feel apprehensive about having their drugs changed [1].Topics covered in the toolkit include the safety of biologicals, how they are regulated and monitored, how they are prescribed and dispensed, who can access them and what information and support is available to patients.”

Read the article here.

In the States…

Idaho

The Idaho Board of Pharmacy adopted the draft biosimilars rule on October 23, that did not include physician communication. The recommendation will go into effect unless two-thirds of the legislature overrides it or enacts independent legislation.

Pennsylvania

The Pennsylvania House of Representatives did not consider the Senate-passed biosimilar substitution legislation SB 405 before adjourning for the session.

Many states have finished their legislative sessions for the year, but ASBM will continue to educate lawmakers and work to ensure patient safety is the main priority as biosimilar policies are created across the country.

Are You Following ASBM on Social Media?

For the latest ASBM activities and updates make sure you are following us via social media:

Twitter: @SafeBiologics

Facebook: https://www.facebook.com/SafeBiologicMedicines

LinkedIn: http://linkd.in/1zhVaCk

YouTube: https://www.youtube.com/channel/UCq9XO-27MVdPcZQcHs6_0vA

Upcoming Conferences:

  • November 25: ASBM Survey Presentation in Madrid, Spain
  • December 2-3: DIA Biosimilars Conference in Berlin, Germany

 

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

November 5, 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.

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