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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.

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
Email: Michael@safebiologics.org

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
Email: Michael@safebiologics.org

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.

EuropaBio Publishes New Paper on Biosimilars

October 9th, 2014

EuropaBio published a new Guide and a new Position Paper on Biosimilars in Europe. With these two documents, EuropaBio continues its contribution to the policy debate on key issues regarding biosimilars among European and national regulators, policy makers, physicians, other healthcare providers and patients.

Read the paper here.

ASBM and Patient Groups Show Support for WHO Biological Qualifier Proposal

October 9th, 2014

ASBM recently showed support for the World Health Organization’s (WHO) draft Biological Qualifier (BQ) proposal by submitting comments to the WHO. ASBM and 14 of its members submitted comments on the BQ proposal released in July 2014, saying it is an encouraging step toward a naming system that will increase safety for patients around the world and that ASBM believes it is an achievable one.

The BQ proposal would assign a four-letter alphabetic code at random to a biological active substance manufactured at a specific site. The WHO proposal outlined a plan for the use of BQ’s as a way to resolve the nomenclature issues worldwide, ensuring clear product identification and promoting manufacturer accountability.

Read the letter here.

ASBM Members who submitted comments include the American Autoimmune Related Diseases Association, International Cancer Advocacy Network, Global Healthy Living Foundation, Kidney Cancer Association, Global Colon Cancer Association, Alliance for Patient Access, American Academy of Dermatology, Zero – the End of Prostate Cancer, National Hispanic Medical Association, National Psoriasis Foundation, Health HIV, American Association for People with Disabilities, Colon Cancer Alliance and RetireSafe.