Posts – Page 34 – Safe Biologics

ASBM Exhibits at DIA 2018 Conference

June 30, 2018

From June 25-27, ASBM exhibited at the 2018 Drug Industry Association Conference (DIA 2018). ASBM was represented at DIA by Chair Madelaine Feldman MD, FACR and Advisory Board Chair Philip Schneider, MS FASHP.

*Dr. Schneider, left, and Dr. Feldman, right, met with conference attendees for three days at the ASBM booth, to discuss biosimilar policy issues including naming and substitution practices.*

In addition to meeting attendees at ASBM’s booth, Drs. Feldman and Schneider attended several panels related to biosimilar policy, and engaged participants in discussions of key policy issues. For example:

At a panel on interchangeability, Dr. Feldman asked the FDA’s Leah Christl to clarify whether interchangeability would be transitive. That is, would the FDA would treat two biosimilars- each interchangeable with the same reference product -as interchangeable with each other? Dr. Christl clarified in her answer that no, interchangeability would only be granted to a biosimilar with respect to its reference product and not to another biosimilar, even one deemed interchangeable to that some reference product.

At a panel entitled Global Regulatory Strategies for Biosimilars, Dr. Schneider asked panelists if they supported global harmonization with distinct non-proprietary names and was met with universal support.

Later, Dr. Schneider attended a panel entitled Biosimilar interchangeability: A global perspective. When he asked the panel about the value of distinct naming and international harmonization for improving pharmacovigilance and increasing biosimilar uptake, the panel agreed that real world evidence is critical to uptake and that harmonizing global nonproprietary names is vital in making this happen.

*Drs. Schneider and Feldman discuss the value of international harmonization of biologic nomenclature with Taiwanese FDA official Lien-Chien Chang.*

In addition to the ASBM’s presence in the exhibit hall and at biosimilar sessions, an oped by ASBM executive director Michael Reilly was featured in Drug Industry News, a publication distributed to conference attendees. ASBM also used print advertising and tabletop art at the conference to promote its surveys of physicians in 12 countries and of US pharmacists, which show broad support for distinct naming of all biologics, including biosimilars.

ASBM augmented its presence in the exhibit hall and at biosimilar sessions with advertising and an op-ed in Drug Industry News, a publication distributed to conference attendees. Each focused on the value of distinct biologic naming and international harmonization.

*Conference attendees gather around a table in the refreshment area, on of several featuring ASBM survey data showing strong support for distinct naming among physicians worldwide.*

ASBM Presents at World Health Professions Regulation Conference

June 19, 2018

On May 17th, ASBM presented an abstract during the poster session at the World Health Professions Regulation Conference 2018 in Geneva, Switzerland.

ihprc2018-posterphil

ASBM’s poster, entitled “How do policymakers realize the cost-savings from biosimilars while maintaining healthcare provider autonomy?” draws from ASBM’s surveys of 1,832 physicians in 12 countries and 401 pharmacists in the U.S.

The findings were presented by ASBM’s International Advisory Board Chair, Philip J. Schneider, MS, FASHP, FASPEN, FFIP; who co-authored the abstract with ASBM Executive Director, Michael Reilly, Esq.

The conference, in its fifth year, is sponsored by the World Health Professions Alliance, an international organization representing dentists, nurses, pharmacists, physicians, and physical therapists.

Read more about WHPRC 2018 here.

View the poster here.

ASBM Meets with Patient Groups Worldwide at IAPO Conference

June 19, 2018

On May 23rd-24th, ASBM attended the International Alliance of Patients’ Organizations 8^th Global Patients Congress.

The meeting was attended by approximately 80 different patient groups and 130 participants from around the globe which convene on a number of health topics—including sessions on how best to engage regulators worldwide and a 101 on biosimilar medicines. ASBM also hosted a booth which highlighted the importance of the harmonization of naming schemes for biologics and biosimilars and included a poster presentation of results from physicians in 12 countries surveyed by ASBM. View the poster here.

*ASBM’s Niko Stemple (right) meets with a patient advocate.*

At the meeting ASBM Steering Committee member and Global Colon Cancer Association Executive Director, Andrew Spiegel, was named as the Chair-elect to be IAPO Chairman in August of 2020.

“We send ASBM’s congratulations to Andy for his recognition as a top notch global patient advocate and look forward to his leadership at IAPO,” stated Dr. Madelaine Feldman, ASBM Chair.

ASBM Welcomes New Member Esperantra

At the 2018 IAPO meeting, ASBM engaged with many patient organizations and as a result would like to welcome Esperantra to ASBM membership.

Esperantra is a non-profit organization created for the purpose of contributing to the reduction of cancer mortality in Peru by improving the quality of life of cancer patients, and advocating for equality in access to quality treatments and to innovative care. Esperantra is the first organization of its kind to provide information and support, and to advocate on behalf of cancer patients through its different programs. Their mission is to inform, educate and empower people to achieve a timely diagnosis through prevention programs and to access treatments to control the disease.

Through the meeting of Director Karla Ruiz De Castilla Yabar, ASBM learned that Esperantra has been following regulations in their country on biologic medicines and been active in giving lectures on the issue.

We welcome Esperantra to ASBM’s membership—especially as we tackle such global issues as the naming of biologics and biosimilars,” stated ASBM Executive Director, Michael Reilly. “All patients, no matter what continent they live, should be able to benefit from knowing that their medicines are safe and effective. The harmonization of biologic naming will benefit all patients, no matter where they are being treated.”

Learn more about Esperantra here.

ASBM Meets with Patient Groups Worldwide at IAPO Conference

June 19, 2018

On May 23rd-24th, ASBM attended the International Alliance of Patients’ Organizations 8^th Global Patients Congress.

The meeting was attended by approximately 80 different patient groups and 130 participants from around the globe which convene on a number of health topics—including sessions on how best to engage regulators worldwide and a 101 on biosimilar medicines. ASBM also hosted a booth which highlighted the importance of the harmonization of naming schemes for biologics and biosimilars and included a poster presentation of results from physicians in 12 countries surveyed by ASBM. View the poster here.

At the meeting ASBM Steering Committee member and Global Colon Cancer Association Executive Director, Andrew Spiegel, was named as the Chair-elect to be IAPO Chairman in August of 2020.

“We send ASBM’s congratulations to Andy for his recognition as a top notch global patient advocate and look forward to his leadership at IAPO,” stated Dr. Madelaine Feldman, ASBM Chair.

ASBM Welcomes New Member Esperantra

At the 2018 IAPO meeting, ASBM engaged with many patient organizations and as a result would like to welcome Esperantra to ASBM membership.

Esperantra is a non-profit organization created for the purpose of contributing to the reduction of cancer mortality in Peru by improving the quality of life of cancer patients, and advocating for equality in access to quality treatments and to innovative care. Esperantra is the first organization of its kind to provide information and support, and to advocate on behalf of cancer patients through its different programs. Their mission is to inform, educate and empower people to achieve a timely diagnosis through prevention programs and to access treatments to control the disease.

Through the meeting of Director Karla Ruiz De Castilla Yabar, ASBM learned that Esperantra has been following regulations in their country on biologic medicines and been active in giving lectures on the issue.

We welcome Esperantra to ASBM’s membership—especially as we tackle such global issues as the naming of biologics and biosimilars,” stated ASBM Executive Director, Michael Reilly. “All patients, no matter what continent they live, should be able to benefit from knowing that their medicines are safe and effective. The harmonization of biologic naming will benefit all patients, no matter where they are being treated.”

Learn more about Esperantra here.

ASBM Presents on Naming at World Biosimilar Congress USA 2018

June 12, 2018

On May 24th, ASBM presented at the World Biosimilars Congress USA 2018 in San Diego, CA. The theme of the two-day conference was “Helping the global industry bring biosimilars to the US” and it drew more than 100 attendees including representatives from the industry, health care professionals, and payers.

ASBM Advisory Chair Philip Schneider gave a presentation entitled “Biologic nomenclature: Implementation of an internationally harmonized system”. The presentation offered an overview of the state of international harmonization in the area of biologic naming, including examination of the naming policies of major national regulators and views of health professionals worldwide regarding the need for all biologics, including biosimilars to have distinct non-proprietary names.

Dr. Schneider discussed the feasibility of four-letter suffixes -as proposed by the World Health Organization (WHO) and enacted by the U.S. Food and Drug Administration (FDA)- in addressing this need. He also offered his observations from ASBM’s April 11th naming forum in Washington, DC and his April 30th meeting with WHO in Geneva, emphasizing the importance of the WHO assuming a leadership role on this issue:

“International harmonization is key to building a strong global system of pharmacovigilance, and countries without robust pharmacovigilance systems in place may benefit the most from distinct naming and international harmonization. WHO leadership is essential to achieve this and avoid further proliferation of country-specific naming schemes.”

View Dr. Schneider’s presentation here.

ASBM Presents on Naming at World Biosimilar Congress USA 2018

June 12, 2018

On May 24th, ASBM presented at the World Biosimilars Congress USA 2018 in San Diego, CA. The theme of the two-day conference was “Helping the global industry bring biosimilars to the US” and it drew more than 100 attendees including representatives from the industry, health care professionals, and payers.

ASBM Advisory Chair Philip Schneider gave a presentation entitled “Biologic nomenclature: Implementation of an internationally harmonized system”. The presentation offered an overview of the state of international harmonization in the area of biologic naming, including examination of the naming policies of major national regulators and views of health professionals worldwide regarding the need for all biologics, including biosimilars to have distinct non-proprietary names.

Dr. Schneider discussed the feasibility of four-letter suffixes -as proposed by the World Health Organization (WHO) and enacted by the U.S. Food and Drug Administration (FDA)- in addressing this need. He also offered his observations from ASBM’s April 11th naming forum in Washington, DC and his April 30th meeting with WHO in Geneva, emphasizing the importance of the WHO assuming a leadership role on this issue:

“International harmonization is key to building a strong global system of pharmacovigilance, and countries without robust pharmacovigilance systems in place may benefit the most from distinct naming and international harmonization. WHO leadership is essential to achieve this and avoid further proliferation of country-specific naming schemes.”

View Dr. Schneider’s presentation here.

FDA Approves 11th Biosimilar

June 6, 2018

On June 4th, the U.S. Food and Drug Administration approved its eleventh biosimilar, Fulphila (pegfilgrastim-jmdb).

This is the first biosimilar to Neulasta (pegfilgrastim) and is prescribed to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.

“Bringing new biosimilars to patients is a top priority for the FDA, and a key part of our efforts to help promote competition that can reduce drug costs and promote access,” said FDA Commissioner Scott Gottlieb, M.D.

Read the FDA’s press release about the approval here.

FDA Approves 11th Biosimilar

June 6, 2018

On June 4th, the U.S. Food and Drug Administration approved its eleventh biosimilar, Fulphila (pegfilgrastim-jmdb).

This is the first biosimilar to Neulasta (pegfilgrastim) and is prescribed to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.

“Bringing new biosimilars to patients is a top priority for the FDA, and a key part of our efforts to help promote competition that can reduce drug costs and promote access,” said FDA Commissioner Scott Gottlieb, M.D.

Read the FDA’s press release about the approval here.

ASBM Presents at World Health Professions Regulation Conference

May 20, 2018

On May 19th, ASBM presented an abstract during the poster session at the World Health Professions Regulation Conference 2018 in Geneva, Switzerland.

ASBM’s poster, entitled “How do policymakers realize the cost-savings from biosimilars while maintaining healthcare provider autonomy?” draws from ASBM’s surveys of 1,832 physicians in 12 countries and 401 pharmacists in the U.S.

The findings were presented by ASBM’s International Advisory Board Chair, Philip J. Schneider, MS, FASHP, FASPEN, FFIP; who co-authored the abstract with ASBM Executive Director, Michael Reilly, Esq.

The conference, in its fifth year, is sponsored by the World Health Professions Alliance, an international organization representing dentists, nurses, pharmacists, physicians, and physical therapists.

Read more about WHPRC 2018 here.

View the poster here.

ASBM Presents at 66th WHO Naming Meeting

May 18, 2018

On May 1st, ASBM Executive Director, Michael Reilly, Esq. and Advisory Board Chair, Philip Schneider, MS, FASHP; presented before the 66th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the tenth INN Consultation at which ASBM has presented since 2013.

While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary for the 65th INN Consultation may be viewed here.

The day prior to the meeting, ASBM met with Asst. Director-General Mariângela Simão; Head of Regulation of Medicines and other Health Technologies Emer Cooke, and INN Programme Manager Rafaella Balocco, to discuss the status of the BQ proposal. In July 2014, the INN Expert Group put forward the BQ recommendation for a distinguishable naming approach, however to date, this policy has yet to be implemented. Should the WHO advance the BQ proposal, it would give other nations around the world a model that they may choose to adopt, thereby creating a world standard.

ASBM surveys have shown strong support for distinct naming among physicians worldwide. Sixty-six percent of U.S. physicians surveyed support distinct naming for all biologics including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

In addition, the April 11 meeting on Harmonization of Biologic Nomenclature sponsored by ASBM revealed strong stakeholder support both for distinct naming and for international harmonization of naming systems; participants agreed that WHO involvement was necessary to advance these aims. The meeting included representatives from FDA, Health Canada, physician societies, pharmacists, and patient advocacy organizations.