The Biosimilar Working Group, a Canadian-based coalition of non-profit organizations, registered health charities, and health care advocacy coalitions, launched its website this month. The launch was announced in conjunction with the Group’s September meeting in Toronto, ON.
The Biosimilars Working Group is dedicated to ensuring that good outcomes for patients are at the centre of health policy in Canada, specifically in the biologic medication treatment areas. It creates up-to-date and evidence-based educational material for patients and health care professionals as a basis to inform our advocacy work on behalf of the patients who we serve.
Educational videos on the group’s website include:
“ASBM has been active in Canadian biosimilars policy since 2013, twice surveying physicians, consulting with our Canadian members, and sharing these perspectives with Federal regulators and Provincial policymakers.” notes ASBM executive director Michael Reilly, who attended the September meeting. Mr. Reilly presented an update on efforts to harmonize biologic and biosimilar naming systems internationally, including two recent ASBM-sponsored meetings attended by representatives from FDA, Health Canada, WHO; and physician, pharmacist and patient organizations. “We are honored to be a part of the Biosimilars Working Group as we work together to keep Canadian biosimilar policy patient-focused and science-based,” said Reilly.
The Biosimilar Working Group, a Canadian-based coalition of non-profit organizations, registered health charities, and health care advocacy coalitions, launched its website this month. The launch was announced in conjunction with the Group’s September meeting in Toronto, ON.
The Biosimilars Working Group is dedicated to ensuring that good outcomes for patients are at the centre of health policy in Canada, specifically in the biologic medication treatment areas. It creates up-to-date and evidence-based educational material for patients and health care professionals as a basis to inform our advocacy work on behalf of the patients who we serve.
Educational videos on the group’s website include:
“ASBM has been active in Canadian biosimilars policy since 2013, twice surveying physicians, consulting with our Canadian members, and sharing these perspectives with Federal regulators and Provincial policymakers.” notes ASBM executive director Michael Reilly, who attended the September meeting. Mr. Reilly presented an update on efforts to harmonize biologic and biosimilar naming systems internationally, including two recent ASBM-sponsored meetings attended by representatives from FDA, Health Canada, WHO; and physician, pharmacist and patient organizations. “We are honored to be a part of the Biosimilars Working Group as we work together to keep Canadian biosimilar policy patient-focused and science-based,” said Reilly.
Left to right: ASBM Immediate Past Chair Harry Gewanter, MD; ASBM Chair Madelaine Feldman MD; Steering Committee Member Kathleen Arntsen of Lupus and Allied Diseases Association; and ASBM Founding Chair Richard Dolinar, MD.
On September 4th, 2018, the U.S. Food and Drug Administration (FDA) held a hearing on the Biosimilar Action Plan announced by FDA Commissioner Scott Gottlieb in July. The action plan addressed 4 key areas intended to improve biosimilar competition:
Improving the efficiency of the biosimilar and interchangeable product development and approval process
Maximizing scientific and regulatory clarity for the biosimilar product development community
Developing effective communications to improve understanding of biosimilars among patients, providers, and payers
Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products
All Three of ASBM’s Chairmen Presented
ASBM’s current Chair, Madelaine Feldman, MD FACR gave an eight-minute presentation followed by a three-minute Q&A period during which she answered questions from the FDA panel.
ASBM Chair Madelaine Feldman presents.
Dr. Feldman’s comments featured prominently in in this Bloomberg news coverage of the hearing:
“Theoretically, by putting [biosimilars] on drug formularies, PBMs rake in lower profits because reimbursements for biosimilars aren’t as high as reimbursements for the original biologic, PBM critics say. That lack of formulary access for biosimilars is called the “formulary wall” and is one of the biggest factors keeping biosimilars from reaching patients, according to drugmakers, patient groups, and biosimilar advocates.”
“The barriers to access are not scientific but commercial,” Madelaine Feldman, the chair of the Alliance for Safe Biologic Medicines, said at a public hearing at the FDA’s headquarters Sept. 4. The group is made up of doctors’ associations and patient groups.
ASBM’s Immediate Past Chair, Harry Gewanter, MD MACR; (ASBM Chair 2014-2017) and ASBM’s founding Chairman, endocrinologist Richard Dolinar, MD (ASBM Chair 2011-2014) also gave eight-minute presentations sharing their clinical perspectives, followed by a three-minute Q&A portion.
Key themes of the physician presentations included:
Praise for the FDA’s strong, science-based standards and concern that the lowering of these standards could undermine confidence
An emphasis on barriers to biosimilar uptake being largely post-approval (PBM rebates, litigation)
The need for physicians and patients to control treatment decisions rather than a third-party such as an insurer or PBM
How the gathering of real world evidence on biosimilar use, particularly among patients who switch, can build physician confidence
The importance of distinct biologic/biosimilar naming to pharmacovigilance and of working toward international harmonization with WHO and other regulators
Urging FDA to provide further clarification on follow-on biologics approved under the 505(b)(2) that are due to transition in 2020 to the 351 (a) stand-alone biologic or 351(k) biosimilar pathway.
Four ASBM Steering Committee Members Presented
Four ASBM Steering Committee Members also gave eight-minute presentations: Andrew Spiegel, Executive Director of the Global Colon Cancer Association; Kathleen Arntsen of Lupus and Allied Diseases Association, Randall Rutta of the American Autoimmune Related Disorders Association, and Sarah Aoanan of the Global Healthy Living Foundation.
Left to right: Kathleen Arntsen of LADA; ASBM’s Immediate Past Chair Harry L. Gewanter MD; and Sarah Aoanan of GHLF.
Key themes of the patient presentations included:
The importance of FDA not sacrificing quality, safety, or efficacy standards in biosimilar approvals
Excitement among the patient advocate community about biosimilars offering new treatment choices and reduced costs
The expectation that biosimilar policies must be science-based and patient-focused
The importance of leaving treatment decisions, including the decision to switch medicines, to the patient and his or her healthcare team
Kathleen Arntsen, President & CEO of Lupus and Allied Diseases Association; testifies before the FDA panel.
Finally, two ASBM members offered three-minute testimony during the Open Public Hearing portion: Thair Phillips of RetireSafe, and Dr. David Charles from Alliance for Patient Access (AfPA).
Left to right: ASBM Immediate Past Chair Harry Gewanter, MD; ASBM Chair Madelaine Feldman MD; Steering Committee Member Kathleen Arntsen of Lupus and Allied Diseases Association; and ASBM Founding Chair Richard Dolinar, MD.
On September 4th, 2018, the U.S. Food and Drug Administration (FDA) held a hearing on the Biosimilar Action Plan announced by FDA Commissioner Scott Gottlieb in July. The action plan addressed 4 key areas intended to improve biosimilar competition:
Improving the efficiency of the biosimilar and interchangeable product development and approval process
Maximizing scientific and regulatory clarity for the biosimilar product development community
Developing effective communications to improve understanding of biosimilars among patients, providers, and payers
Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products
All Three of ASBM’s Chairmen Presented
ASBM’s current Chair, Madelaine Feldman, MD FACR gave an eight-minute presentation followed by a three-minute Q&A period during which she answered questions from the FDA panel.
ASBM Chair Madelaine Feldman presents.
Dr. Feldman’s comments featured prominently in in this Bloomberg news coverage of the hearing:
“Theoretically, by putting [biosimilars] on drug formularies, PBMs rake in lower profits because reimbursements for biosimilars aren’t as high as reimbursements for the original biologic, PBM critics say. That lack of formulary access for biosimilars is called the “formulary wall” and is one of the biggest factors keeping biosimilars from reaching patients, according to drugmakers, patient groups, and biosimilar advocates.”
“The barriers to access are not scientific but commercial,” Madelaine Feldman, the chair of the Alliance for Safe Biologic Medicines, said at a public hearing at the FDA’s headquarters Sept. 4. The group is made up of doctors’ associations and patient groups.
ASBM’s Immediate Past Chair, Harry Gewanter, MD MACR; (ASBM Chair 2014-2017) and ASBM’s founding Chairman, endocrinologist Richard Dolinar, MD (ASBM Chair 2011-2014) also gave eight-minute presentations sharing their clinical perspectives, followed by a three-minute Q&A portion.
Key themes of the physician presentations included:
Praise for the FDA’s strong, science-based standards and concern that the lowering of these standards could undermine confidence
An emphasis on barriers to biosimilar uptake being largely post-approval (PBM rebates, litigation)
The need for physicians and patients to control treatment decisions rather than a third-party such as an insurer or PBM
How the gathering of real world evidence on biosimilar use, particularly among patients who switch, can build physician confidence
The importance of distinct biologic/biosimilar naming to pharmacovigilance and of working toward international harmonization with WHO and other regulators
Urging FDA to provide further clarification on follow-on biologics approved under the 505(b)(2) that are due to transition in 2020 to the 351 (a) stand-alone biologic or 351(k) biosimilar pathway.
Four ASBM Steering Committee Members Presented
Four ASBM Steering Committee Members also gave eight-minute presentations: Andrew Spiegel, Executive Director of the Global Colon Cancer Association; Kathleen Arntsen of Lupus and Allied Diseases Association, Randall Rutta of the American Autoimmune Related Disorders Association, and Sarah Aoanan of the Global Healthy Living Foundation.
Left to right: Kathleen Arntsen of LADA; ASBM’s Immediate Past Chair Harry L. Gewanter MD; and Sarah Aoanan of GHLF.
Key themes of the patient presentations included:
The importance of FDA not sacrificing quality, safety, or efficacy standards in biosimilar approvals
Excitement among the patient advocate community about biosimilars offering new treatment choices and reduced costs
The expectation that biosimilar policies must be science-based and patient-focused
The importance of leaving treatment decisions, including the decision to switch medicines, to the patient and his or her healthcare team
Kathleen Arntsen, President & CEO of Lupus and Allied Diseases Association; testifies before the FDA panel.
Finally, two ASBM members offered three-minute testimony during the Open Public Hearing portion: Thair Phillips of RetireSafe, and Dr. David Charles from Alliance for Patient Access (AfPA).
On July 18th, ASBM Advisory Chair Philip Schneider gave a presentation to the Malta Pharmaceutical Association 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. It also focused on the need for Real World Evidence (RWE) and improved pharmacovigilance in a world where biosimilars are approved with an emphasis on analytics rather than clinical trials.
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 these needs. He also offered his observations from ASBM’s April 11th naming forum in Washington, DC, his April 30th meeting with WHO in Geneva, and ASBM’s July 12th Forum in Washington, DC. 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.”
On July 18th, ASBM Advisory Chair Philip Schneider gave a presentation to the Malta Pharmaceutical Association 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. It also focused on the need for Real World Evidence (RWE) and improved pharmacovigilance in a world where biosimilars are approved with an emphasis on analytics rather than clinical trials.
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 these needs. He also offered his observations from ASBM’s April 11th naming forum in Washington, DC, his April 30th meeting with WHO in Geneva, and ASBM’s July 12th Forum in Washington, DC. 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.”
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.
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.
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 11th 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 11th meeting can be found here.
Photos from the April 11th roundtable can be found here.
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.
