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. 

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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 11th 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.

Springer-Nature-Luncheon-The Source-Washington-DC
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.

img_1203
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.

Springer-Nature-Luncheon-The Source-Washington-DC
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 1st at the 66th 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.”

 

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ASBM Hosts Forum on International Naming Harmonization

April 12, 2018

On April 11th 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.

Springer-Nature-Luncheon-The Source-Washington-DC
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.

img_1203
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.

Springer-Nature-Luncheon-The Source-Washington-DC
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 1st at the 66th 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.”

 

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93% of Americans are Now Covered by Biosimilar Substitution Laws

April 1, 2018

Philip J. Schneider, MS FASHP
ASBM Advisory Board Chair

This week, West Virginia Governor Jim Justice and Wisconsin Governor Scott Walker signed bills updating pharmacy regulations in their respective states. The new laws permit pharmacists to substitute interchangeable biosimilars in place of an originator biologic medicine when they are approved by the FDA.

The signing of this legislation means that 41 states and Puerto Rico now have these important measures in place to pave the way for interchangeable biosimilar use while also maintaining the highest standards for patient safety. 93% of Americans can now immediately gain access to affordable new treatment options once the FDA deems a biosimilar as interchangeable.  Each of the states who have added these measures to the books require the timely communication between healthcare providers about which medicine are dispensed, promote the maintenance of an accurate patient record, and preserve a physician’s authority to prevent an inappropriate substitution.

It’s quite a change from when I first became involved with ASBM in September of 2012. At that point, not a single biosimilar had been approved in the U.S., and not a single state had yet updated its Pharmacy Practice Act to permit biosimilar substitution.

From 2013 to 2014, eight forward-thinking states (Delaware, Florida, Indiana, Massachusetts, North Dakota, Oregon, Utah and Virginia) led the way by updating their state pharmacy regulations to allow the safe substitution of interchangeable biologics by acknowledging the need for physician, pharmacist and patient communication in the process of administering these highly complex drugs.

Following the FDA’s approval of the first biosimilar, Zarxio (filgrastim-sndz) in March 2015 another 17 states (Arizona, California, Colorado, Georgia, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Missouri, New Jersey, North Carolina, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Washington) and Puerto Rico had enacted laws by the end of 2016. At that point, the FDA had approved four biosimilars.

In 2017, 11 more states followed (Iowa, Kansas, Maryland, Minnesota, Montana, Nebraska, Nevada, New Mexico, New York, Ohio and South Carolina).  That year the FDA released its Guidance on Interchangeability and approved an additional five biosimilars, bringing the total to nine.

Now as we end the first quarter of 2018, we already have bills in five more states (South Dakota, Michigan, Wyoming, West Virginia and Wisconsin) having been signed into law. Now we are in the home stretch, with only nine states still in need of updating their pharmacy laws.

Over the past five and a half years, it’s been my privilege to work with state legislatures and Boards of Pharmacy to make that happen. As we near the inevitable FDA approval of the first interchangeable biosimilar, it is good to know we are almost at the finish line in ensuring all patients have access to potentially lower cost biologic drug alternatives, while making sure we do not compromise patient safety.

 

 

ASBM Submits Comments to Health Canada on Naming

February 10, 2018

On January 18, 2018, the Institute for Safe Medication Practices Canada (ISMP Canada) posted an online questionnaire to seek input from healthcare providers, consumers, and other interested and affected stakeholders on different approaches to the naming of biologic drugs, including biosimilars, in Canada. ASBM submitted comments on February 9th advocating the use of 4-letter suffixes, an approach favored by the WHO and FDA.

The questionnaire was developed collaboratively with Health Canada. Administration of the questionnaire and analysis of responses will be performed by ISMP Canada.

The objective of the consultation was to gain insight into stakeholder views on the practical impacts of different approaches to the naming of biologic drugs and biosimilars throughout the medication-use process, including prescribing, dispensing, and adverse drug reaction reporting.

Results of the consultation will be used to:

  • understand the impact of different approaches to biologic drug naming and the perspectives of healthcare providers, consumers, and other interested and affected stakeholders, and
  • inform Health Canada’s policy decision on a naming convention for biologic drugs.

 The questionnaire suggested three options for consideration:

OPTION 1:

Continue the current Canadian drug identification and naming approach [status quo]

 

OPTION 2:

Use of the brand name with the non-proprietary name to distinguish among biologics [European approach]

 

OPTION 3:

Implement a 4-letter suffix appended to the non-proprietary name

[supported by the FDA, the WHO, and strong majorities of physicians in Canada and worldwide]

Naming Tool for Biologic Medicines Released; Ensures Compliance with FDA, WHO Standards

February 8, 2018

For Immediate Release

Naming Tool for Biologic Medicines Released;  Ensures Compliance with FDA, WHO Standards

Arlington, VA (February 8, 2018)

 

The Alliance for Safe Biologic Medicines (ASBM) announced today that it has developed a web-based tool for the naming of biologic medicines to quickly ensure compliance with naming standards set forth by the FDA and World Health Organization (WHO). The tool, called “SuffixAudit”, will be made available to regulators and manufacturers.

 

Biologic medicines are complex molecules engineered to treat serious and chronic conditions including rheumatoid arthritis, psoriasis, and cancer. Lower-cost versions of these medicines, known as biosimilars, are becoming available but unlike generics, they are not exact copies of their reference product. These inherent differences have caused health regulators worldwide to make clear product identification a priority. “The distinct naming of all biologics, including biosimilars, allows regulators to accurately track products, ensure their continued safety and efficacy, and attribute any adverse events to the correct product”, said Michael Reilly, executive director of ASBM.

 

To accomplish this, the FDA and WHO have each proposed a system which appends a distinct four-letter suffix to a root name shared by the innovator medicine and all biosimilars to that product. While similar, the FDA and WHO systems employ different sets of rules, including which letters may be used and how many unique letters must be used in a suffix. Both systems exclude suffixes that exhibit meaning (e.g. those that are too similar to company names, stock symbols, or words).

 

ASBM’s SuffixAudit checks a proposed suffix against regularly-updated lists of words, stock symbols, medical and pharmaceutical terms, and combinations not in compliance with FDA or WHO rules. It can also encode suffixes with a 32-bit “checksum”, an additional mathematical safeguard against inadvertent substitution that is required by the WHO Biological Qualifier (BQ) system.

“SuffixAudit allows a manufacturer or regulator to quickly test a potential suffix against the FDA established naming rules for biologics, the WHO’s proposed BQ standard, or both, as regulators continue their work to harmonize naming globally”, said Jeff Jones, PhD; an ASBM Advisory Board member and chief architect of the tool.

 

ASBM has worked closely with the WHO since 2013 in the development and implementation of the BQ system, including providing survey data which shows broad support for distinct naming among physicians worldwide. In April 2017, ASBM presented the WHO with a precursor to SuffixAudit called “SuffixDB” which empirically demonstrated the feasibility of implementing the four-letter suffix system by generating many thousands of BQ-compliant suffixes and reliably detecting any potential conflicts or rule violations.

 

“SuffixAudit represents the next generation in biologic naming compliance and will help to streamline the implementation of this approach in any region wishing to pursue distinguishable names. Manufacturers and regulators will be able to name biologics and biosimilars with confidence, ensuring clear product identification regardless of which of the two suffix systems is ultimately adopted as the global standard. ASBM looks forward to meeting with regulators in coming months to offer SuffixAudit as an aid to implementation of distinct naming and to international harmonization” said Mr. Reilly.

 

About the Alliance for Safe Biologic Medicines

 

The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups including physicians, patients, pharmacists, manufactures of innovator biologics and biosimilars, researchers, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.

 

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For more information, please contact:

 

Michael Reilly

Executive Director

Alliance for Safe Biologic Medicines

Phone: 202-222-8326

Email: Michael@safebiologics.org

 

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