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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.

 

ASBM in Brazil

October 9th, 2014

ASBM has traveled to cities around the world to participate in regulatory discussions on how to best achieve global safety standards for biosimilars. In August 2014, ASBM representatives took part in several meetings in Rio de Janeiro, Brazil for two different conferences.

ASBM Chairman Dr. Harry Gewanter was a guest speaker at the August 13 “4th Latin America Forum on Biosimilars” where he gave a presentation on interchangeability. He explained the current legislative landscape in the U.S. and highlighted that:

  • It is important to physicians that they retain the authority to use “do not substitute” to ensure the patient receives their chosen medicine
  • It is important to physicians that they are informed in a timely fashion of the medicine(s) the patient receives and if it is different than what they prescribed
  • Distinguishable INNs are important to the practicing physicians in the U.S. and Europe

View his presentation here.

Ten days later, Global Colon Cancer Association Executive Director, Andrew Spiegel participated in the International Alliance of Patients’ Organizations (IAPO) “Increasing the Patient voice in drug regulatory Authorities” meeting in Rio de Janeiro and then presented at the “Pre-International Conference of Drug Regulatory Authorities” on August 24. In his presentation, Spiegel highlighted the need for distinguishable nonproprietary names as a means of keeping patients safe. He urged support for the WHO BQ proposal, which lays the groundwork for creating consistent global policies on naming.

View his presentation here.

BioPharma Article Highlights Important Role of CROs in Biosimilar Development

October 1st, 2014

A September 17 BioPharma article pointed out that almost all of the biosimilars currently approved have been developed using a third-party research organisation according to a survey from the Association of Clinical Research Organizations (ACRO).

Read “Fastest Way to Biosimilar Approval? As the CRO flies” here.

ASBM and Patient Advocates Write FDA on Naming

August 14th, 2014

The Alliance for Safe Biologic Medicines (ASBM), along with dozens of patient organizations, write Commissioner Hamburg to encourage the FDA to adopt a policy of distinguishable nonproprietary names for biosimilars and to issue guidance reflecting distinguishable naming as a priority for the well-being of patients.

Read full letter here.

ASBM Names Harry L. Gewanter, MD as Incoming Chairman; Dean Philip Schneider as International Advisory Board Chair

August 7th, 2014

ARLINGTON, VA – Michael Reilly, executive director of the Alliance for Safe Biologic Medicines (ASBM) today announced pediatric rheumatologist and current ASBM International Advisory Board (IAB) member, Harry L. Gewanter, MD, FAAP, FACR as ASBM’s incoming chairman. In addition, Philip Schneider, MS, FASHP, Professor and Associate Dean at the University of Arizona, College of Pharmacy will serve as the International Advisory Board Chair. Dr. Schneider has served on the ASBM advisory board since September 2012.

“As a member of our International Advisory Board for three years, Dr. Gewanter has been instrumental in helping to craft ASBM’s policy recommendations and has taken an active role in its policy development and education efforts,” said Reilly. “We are excited for Dr. Gewanter to take a more prominent role within the organization and utilize his expertise to forward ASBM’s mission.”

Dr. Gewanter succeeds outgoing chairman Richard Dolinar, MD, who served as ASBM’s initial chairman since 2011. Dolinar has testified before the U.S. Food and Drug Administration (FDA) and the World Health Organization’s (WHO) International Nonproprietary Naming Consultation, as well as appeared as a global keynote speaker.

“Dr. Dolinar oversaw the creation, growth and maturation of ASBM — from an organization focused on shaping the biosimilar approval pathway in the United States to an internationally recognized voice that speaks for patient’s with serious chronic illnesses and the physicians who care for them,” said Dr. Gewanter. “During his tenure, Dr. Dolinar has assisted regulatory bodies as they craft international standards for biosimilars. I look forward to continuing his work as chairman and elevating the voice of patients and physicians in global regulatory decisions to provide patients and physicians additional safe and effective treatment options and greater transparency as biosimilars enter the marketplace.”

“Dr. Dolinar has been an outstanding leader in the education of physicians, patients and policymakers alike in the relatively new arena of biologics and biosimilars,” stated Reilly. “Under his leadership, our membership and impact has grown and we are grateful for his guidance of ASBM.”

Philip Schneider, will also serve ASBM in a new capacity as IAB Chair. During his tenure on ASBM’s Advisory Board, Dr. Schneider has helped educate policymakers on the importance of developing biosimilar policies that encourage collaboration between pharmacists and physicians.

“Pharmacists have an important role to play in the discussion of how biosimilars are treated and we are also the linchpin between patients and the medicines they take, ” stated Schneider. “I look forward to ensuring the pharmacy setting is equipped with the regulations needed to both ensure the safe administration of biosimilars, as well as provide access to potentially lower-cost alternatives to patients.”

Dr. Gewanter and Dr. Schneider will continue ASBM’s global advocacy for policies aimed at ensuring that patients worldwide receive the biologic they were prescribed, that biosimilars are held to high standards of safety and efficacy, and that these medicines can be reliably tracked for adverse events. Gewanter and Schneider will assume their positions on September 1.

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