Posts – Page 34 – Safe Biologics

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.

FDA Approves Tenth Biosimilar

May 15, 2018

On May 15th, the U.S. Food and Drug Administration approved its tenth biosimilar, Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

“It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products,” said Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”

The FDA’s approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit. Retacrit has been approved as a biosimilar, not as an interchangeable product.

Read more about the FDA’s approval here.

FDA Approves Tenth Biosimilar

May 15, 2018

On May 15th, the U.S. Food and Drug Administration approved its tenth biosimilar, Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

“It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products,” said Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”

The FDA’s approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit. Retacrit has been approved as a biosimilar, not as an interchangeable product.

Read more about the FDA’s approval here.

ASBM Hosts Forum on International Naming Harmonization

April 12, 2018

On April 11^th in Washington DC, nearly 25 individuals gathered to be part of an exclusive roundtable to discuss a global approach for naming harmonization of biologic medicines. Representatives from the U.S. Food and Drug Administration, Health Canada, physician and pharmacist associations, and patient advocacy organizations convened to explore the feasibility of this endeavor and what steps might be taken to operationalize a global naming scheme.

Health Canada’s Anthony Ridgway, left, and ASBM President Doug Badger, right, listen as ASBM Executive Director Michael Reilly discusses the value of internationally-harmonized biologic naming.

The Alliance for Safe Biologic Medicines (ASBM), in partnership with Scientific American, hosted the event. Brady Huggett, Business Editor of Nature Biotechnology, a Scientific American publication, moderated the event.

Since their introduction into global healthcare markets a decade ago, biosimilars have greatly expanded treatment options. For example, to date, nine biosimilars have received FDA approval in U.S. with 240 in the development pipeline; in Europe 28 biosimilars have been approved in the past 10 years.

However, global harmonization of biologic naming has not yet been achieved—a situation that may impede pharmacovigilance, patient safety, prescriber clarity and even uptake of these medicines. This is because the regulatory agencies in different countries have varied in their approaches to the naming biologics and biosimilars.

At the meeting, it was clear that participants agreed that distinguishable names and a harmonization of naming conventions across regions for all biologics (innovator and biosimilar) would ultimately improve patient safety and access.

Andrew Spiegel of the Global Colon Cancer Association emphasizes the value of distinguishable naming for patients worldwide.

“Through clarity, you get safety,” stated Peter Pitts, President of the Centers for Medicine in the Public Interest and former Associate Commissioner for External Relations at the FDA.

Former FDA Associate Commissioner Peter Pitts comments on the value of unique naming for all biologics.

ASBM intends to present the perspectives shared at this meeting to the World Health Organization (WHO) at its appearance May 1^st at the 66^th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. In addition, Scientific American will write a white paper on the proceedings to be published in Nature Biotechnology.

ASBM Executive Director Michael Reilly expressed hope that the conversation will continue and broaden to include other regulators such as the WHO, Australia’s Therapeutic Goods Administration (TGA) and Brazilian Health Regulatory Agency ANVISA: “It is [ASBM’s] intent that this forum not be a stand-alone event but rather the first in a series of meetings and part of the ongoing global conversation on this issue.”

###