Posts – Page 35 – Safe Biologics

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

Alex Azar Sworn in as HHS Secretary

February 2, 2018

On January 29th, Alex Azar was sworn in as Secretary of the Department of Health and Human Services (HHS) by Vice President Mike Pence following remarks by President Trump. ASBM Executive Director Michael Reilly, who served as Mr. Azar’s Deputy from 2005-2007, was in attendance.

Mr. Azar previously spent four years as the Department’s general counsel, and two years as Deputy Secretary. After leaving the Department, Mr. Azar spent five years as President of Lilly USA. Mr. Azar was confirmed January 25th by the Senate with a vote of 55-43.

For the full vote, see here.

Alex Azar Sworn in as HHS Secretary

February 2, 2018

On January 29th, Alex Azar was sworn in as Secretary of the Department of Health and Human Services (HHS) by Vice President Mike Pence following remarks by President Trump. ASBM Executive Director Michael Reilly, who served as Mr. Azar’s Deputy from 2005-2007, was in attendance.

Mr. Azar previously spent four years as the Department’s general counsel, and two years as Deputy Secretary. After leaving the Department, Mr. Azar spent five years as President of Lilly USA. Mr. Azar was confirmed January 25th by the Senate with a vote of 55-43.

For the full vote, see here.

TGA Releases Response to Stakeholder Naming Consultation

January 26, 2018

On January 24th, the Australian Therapeutic Goods Administration (TGA) released the response to its recent stakeholder consultation on biosimilar naming. The regulator sought input on whether or not it should use distinguishing suffixes for biologics and biosimilars to improve product identification and adverse event reporting. A suffix approach is currently supported by the World Health Organization, the U.S. FDA, and Health Canada. The TGA received 34 responses, which were divided on the merits of using distinguishing suffixes.

In a comment letter dated September 7th, ASBM responded, advocating for distinct naming of all biologics and biosimilars, and urging the TGA to adopt the World Health Organization’s Biological Qualifier (BQ) proposal. The distinct naming approach was also endorsed by Australian physician societies, patient advocacy organizations, and several biologic manufacturers.

Ultimately however, the TGA decided to continue to follow the approach used by the European Medicines Agency (using a biosimilar’s trade name in conjunction with a shared nonproprietary name) and work towards additional enhancements including the implementation of a machine-readable barcode on all biologics.

Read more about the TGA response here.

TGA Releases Response to Stakeholder Naming Consultation

January 26, 2018

On January 24th, the Australian Therapeutic Goods Administration (TGA) released the response to its recent stakeholder consultation on biosimilar naming. The regulator sought input on whether or not it should use distinguishing suffixes for biologics and biosimilars to improve product identification and adverse event reporting. A suffix approach is currently supported by the World Health Organization, the U.S. FDA, and Health Canada. The TGA received 34 responses, which were divided on the merits of using distinguishing suffixes.

In a comment letter dated September 7th, ASBM responded, advocating for distinct naming of all biologics and biosimilars, and urging the TGA to adopt the World Health Organization’s Biological Qualifier (BQ) proposal. The distinct naming approach was also endorsed by Australian physician societies, patient advocacy organizations, and several biologic manufacturers.

Ultimately however, the TGA decided to continue to follow the approach used by the European Medicines Agency (using a biosimilar’s trade name in conjunction with a shared nonproprietary name) and work towards additional enhancements including the implementation of a machine-readable barcode on all biologics.

Read more about the TGA response here.

Biosimilar Innovation Plan Part of FDA’s 2018 Strategic Roadmap

January 12, 2018

On January 11th, the FDA released its 2018 Strategic Policy Roadmap, which outlines its key priorities for 2018, including increasing access to new medicines.

“We know that the cost of product development can impact how such products are priced, and can be a factor in limiting patients’ ability to get timely access to beneficial new treatments and services,” said FDA Commissioner Scott Gottlieb. Regarding biosimilars, the Roadmap emphasizes that FDA will focus on making the process for developing and approving biosimilar drugs more efficient, and promoting cost reductions through increased competition:

“As part of these efforts, we will create better incentives for the adoption of safe, effective, and high-quality biosimilar drugs. These policies will be part of a new Biosimilar Innovation Plan (BIP) that we will advance over the coming year.

As FDA improves its policies related to new product development, it is imperative that we balance increased access to lower-cost, generic medicines and biosimilars with the benefits of new product innovation. Competition plays a key role in reducing costs of products like prescription drugs, and enabling broader access to beneficial medicines. Greater access to effective drugs also helps advance the public health and lower overall health care costs by improving health outcomes and reducing the cost and burden of disease. Enabling access to safe and effective innovation that can promote better health is a critical part of FDA’s mandate.”

Read the 2018 Strategic Roadmap here.

CMS Reversal on Shared Billing Codes Will Save $65 Billion

January 5, 2018

On January 4th, the Roanoke Times published an op-ed by Stacie Phan, Executive Director of the Biosimilars Forum, discussing the potential cost savings of biosimilars, especially to the Medicare program:

“…a recent decision by the Centers for Medicare & Medicaid Services to change a billing policy that jeopardized the long-term stability of the biosimilars market could also help pave the way for increased development of biosimilars. The CMS rule change to assign each biosimilar a unique billing code will lead to greater opportunity for increased competition, greater cost savings, and more choices for patients. In fact, the Biosimilars Forum estimates the new rule will reduce Medicare costs by $65 billion over ten years.”

In November, CMS reversed the policy made in 2015 under the Obama Administration, in which all biosimilars sharing one reference product would also share a single billing code. The initial policy had faced broad opposition from manufacturers of biologics and biosimilars, as well as representatives of the physician, pharmacist, and patient communities. ASBM was among these opponents.

On September 11th, 2017, ASBM submitted comments to CMS which reiterated our concerns in detail and urged CMS to reconsider the policy. Learn more about the decision here.

Read the op-ed here.

ASBM Executive Director’s Op-ed Published in Vancouver Sun

December 25, 2017

On December 25th, the Vancouver Sun published an op-ed authored by ASBM Executive Director, Michael Reilly, regarding the topic of Non-Medical Switching of biosimilars. Non-Medical Switching is when a biosimilar is substituted by a third party in place of the biologic medicine prescribed by the physician, for reasons other than the patient’s health or safety.

In the op-ed, Mr. Reilly references the findings of ASBM’s recent survey of 403 Canadian prescribers of biologics:

“Our survey also found that most doctors were not comfortable with a third party switching a patient’s medicine for non-medical reasons. Many worry the different medications may cause adverse effects in patients. I am hoping British Columbia…will play a leadership role in working with Canadian physicians and stakeholders to develop guidelines on the responsible switching of originator biologics and biosimilars.

Biosimilars [offer] patients and physicians lower cost alternatives and different therapeutic options. But for biosimilars to be introduced and used successfully, decision makers must rely on the input and opinions of those who prescribe them.”

Read the full op-ed here.

ASBM Executive Director’s Op-ed Published in Vancouver Sun

December 25, 2017

On December 25th, the Vancouver Sun published an op-ed authored by ASBM Executive Director, Michael Reilly, regarding the topic of Non-Medical Switching of biosimilars. Non-Medical Switching is when a biosimilar is substituted by a third party in place of the biologic medicine prescribed by the physician, for reasons other than the patient’s health or safety.

In the op-ed, Mr. Reilly references the findings of ASBM’s recent survey of 403 Canadian prescribers of biologics:

“Our survey also found that most doctors were not comfortable with a third party switching a patient’s medicine for non-medical reasons. Many worry the different medications may cause adverse effects in patients. I am hoping British Columbia…will play a leadership role in working with Canadian physicians and stakeholders to develop guidelines on the responsible switching of originator biologics and biosimilars.

Biosimilars [offer] patients and physicians lower cost alternatives and different therapeutic options. But for biosimilars to be introduced and used successfully, decision makers must rely on the input and opinions of those who prescribe them.”

Read the full op-ed here.