Posts – Page 32 – Safe Biologics

FDA Approves 12th Biosimilar, 2nd for Filgrastim

July 24, 2018

On July 20th, the FDA approved Pfizer’s Nivestym, (filgrastim-aafi,) the second biosimilar to Neupogen (filgrastim), manufactured by Amgen. The drug is approved for the same indications as the reference product, including decreasing the incidence of infection due to neutropenia. Specifically, the drug has been approved to treat side effects from cancer treatment for patients:

With acute myeloid leukemia receiving induction or consolidation chemotherapy
With cancer receiving myelosuppressive chemotherapy
With cancer undergoing bone marrow transplant
Undergoing autologous peripheral blood progenitor cell collection and therapy
With severe chronic neutropenia

Learn more about the approval here, and view the FDA’s product label for Nivestym (filgrastim-aafi) here.

ASBM Hosts Naming Roundtable With WHO, FDA, Health Canada

July 13, 2018

On July 12, in Washington, DC the Alliance for Safe Biologic Medicines (ASBM) hosted the second in a series of meetings to discuss the global harmonization of nomenclature for biologic and biosimilar medicines.

Representatives from the World Health Organization, the U.S. Food and Drug Administration (FDA), Health Canada, the United States Pharmacopeia (USP), and the American Pharmacists Association (APhA) convened with physician and patient advocacy organizations to discuss the importance of national regulatory authorities (NRAs) working together to develop a nomenclature policy that will improve pharmacovigilance on a global scale.

ASBM International Advisory Board Chair and moderator, Phil Schneider, ASBM Executive Director, Michael Reilly, ASBM President, Doug Badger, and manager of the WHO International Nonproprietary Name (INN) Programme, Dr. Raffella Balocco, WHO

Biologics and biosimilars have greatly expanded treatment options for physicians and patients; yet because of their large molecule structure and manufacturing process which uses living cells, no two biologics are exactly alike. While regulators in some countries have begun to address the naming of these medicines within their own borders, a global harmonization of biologic naming has not yet been achieved. This situation may impede patient safety, prescriber clarity and the uptake of biosimilars as they become more available. It is also more important to less developed countries which may have different standards for approving, tracing and naming medicines.

ASBM believes distinguishable names and a harmonization of naming conventions across regions for all biologics (innovator and biosimilar) would ultimately improve patient safety and access. At the April 11^th meeting, hosted by Scientific American and held in DC, there was also agreement at the table that a harmonized naming system was desirable, not just for biosimilars but for all biologics.

“With the growth of this category of medicines, now is the time to address the policy issues in order to maintain strong pharmacovigilance of these products worldwide,” stated ASBM Executive Director, Michael Reilly, “This is why we are convening these meetings for stakeholders to come to the table and discuss moving towards one naming guidance.”

A recap of the April 11^th meeting can be found here.

Photos from the April 11^th roundtable can be found here.

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 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.

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.

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 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.