Safe Biologics

Conference Shows Strong Support for Distinct Names, Meaningful Suffixes for Biologics Among Pharmacists

NEWPORT, RI – On March 31st, the Alliance for Safe Biologic Medicines (ASBM) gave an educational presentation on biologics and biosimilars for 150 pharmacists attending the 31^st annual Seminar by the Sea conference, held by the University of Rhode Island College of Pharmacy.

ASBM Advisory Board Chair Philip Schneider, Associate Dean at the University of Arizona College of Pharmacy, gave the 45-minute presentation. Dr. Schneider explained the basic science of biologic medicines, the differences between biosimilars and generic medicines, and how these differences pose new regulatory challenges for healthcare providers including pharmacists.

Unlike generic drugs, biosimilars are not exact copies of the medicines on which they are based, and some of these differences can create unexpected effects in patients, including unwanted immune responses. Dr. Schneider emphasized the need for clear product identification when dealing with biologics and biosimilars:

“Pharmacists have traditionally avoided look-alike and sound-alike drug names. Both the World Health Organization (WHO) and Food and Drug Administration (FDA) have proposed systems that use differentiating four-letter suffixes to provide distinct naming for all biologics, including biosimilars. This allows accurate tracking of patient response and of the long-term safety and efficacy of these agents.”

Dr. Schneider noted that national pharmacist societies including the American Pharmacists Association (APhA) and the American Society of Health-system Pharmacists (ASHP), of which Dr. Schneider is a past president, have traditionally opposed distinct naming. Yet while these societies prefer to rely on National Drug Codes (NDCs) to differentiate between similar medicines, rank and file pharmacists are significantly more receptive to the idea of distinct names:

“ASBM found that when we asked pharmacists at our Continuing Education courses, most considered the value of clear product identification with biologics very important or critical. This led us to examine and quantify these perspectives with a survey of 401 U.S. pharmacists. That survey revealed that 68% support the FDA issuing distinct names.”

A poll taken during the speech revealed that of about 150 pharmacists in the audience, an astonishing 97% supported distinct names:

Regulators are still discussing how best to design a differentiating suffix. The FDA’s first approval, for Zarxio (filgrastim-sndz), used a meaningful suffix “-sndz” reflecting the name of its manufacturer, Sandoz. But the WHO and FDA are both soliciting feedback on proposals to instead use random suffixes, which carry no meaning.

ASBM’s survey revealed that 77% of pharmacists prefer a suffix based on the manufacturer name, with only 15% preferring random suffixes. Similarly, the audience poll showed 77% supporting manufacturer-based suffixes, and 21% preferring random suffixes:

Dr. Schneider’s presentation also addressed the issue of biosimilar labeling– including what information is available to providers on the product insert.

Dr. Schneider emphasized that pharmacists want more information and greater transparency than the FDA currently requires. For example, 81% considered it important for the product to state that it is a biosimilar; 69% considered it important to clearly distinguish data generated by the biosimilar from data generated by the originator product; and 88% considered it important to state whether or not the biosimilar is interchangeable with its reference product.

Later that day, the FDA would release its long-awaited Draft Guidance on Labeling, which begins to address some, though not all, of the respondents’ concerns. For example, while it would identify the product as being biosimilar, it would not distinguish which product- the reference or the biosimilar- generated the safety and efficacy data on the biosimilar label. It also does not address whether the biosimilar is or is not interchangeable with its reference product.

Finally, Dr. Schneider discussed the issue of biosimilar substitution at the state level, including what communication should occur between pharmacist and physician following a substitution:

“Collaboration and communication between pharmacists and physicians is critical to providing effective care. Everyone should know which medicine the patient actually receives, so we can make informed assessments of a patient’s response to a particular treatment.”

Since 2013, 19 states and Puerto Rico have enacted laws which permit pharmacists to substitute biosimilars, provided they communicate to the prescribing physician within a 5-to10-day timeframe which product was dispensed.

The full ASBM Pharmacist Survey results may be read here.

Conference Shows Strong Support for Distinct Names, Meaningful Suffixes for Biologics Among Pharmacists

NEWPORT, RI – On March 31st, the Alliance for Safe Biologic Medicines (ASBM) gave an educational presentation on biologics and biosimilars for 150 pharmacists attending the 31^st annual Seminar by the Sea conference, held by the University of Rhode Island College of Pharmacy.

ASBM Advisory Board Chair Philip Schneider, Associate Dean at the University of Arizona College of Pharmacy, gave the 45-minute presentation. Dr. Schneider explained the basic science of biologic medicines, the differences between biosimilars and generic medicines, and how these differences pose new regulatory challenges for healthcare providers including pharmacists.

Unlike generic drugs, biosimilars are not exact copies of the medicines on which they are based, and some of these differences can create unexpected effects in patients, including unwanted immune responses. Dr. Schneider emphasized the need for clear product identification when dealing with biologics and biosimilars:

“Pharmacists have traditionally avoided look-alike and sound-alike drug names. Both the World Health Organization (WHO) and Food and Drug Administration (FDA) have proposed systems that use differentiating four-letter suffixes to provide distinct naming for all biologics, including biosimilars. This allows accurate tracking of patient response and of the long-term safety and efficacy of these agents.”

Dr. Schneider noted that national pharmacist societies including the American Pharmacists Association (APhA) and the American Society of Health-system Pharmacists (ASHP), of which Dr. Schneider is a past president, have traditionally opposed distinct naming. Yet while these societies prefer to rely on National Drug Codes (NDCs) to differentiate between similar medicines, rank and file pharmacists are significantly more receptive to the idea of distinct names:

“ASBM found that when we asked pharmacists at our Continuing Education courses, most considered the value of clear product identification with biologics very important or critical. This led us to examine and quantify these perspectives with a survey of 401 U.S. pharmacists. That survey revealed that 68% support the FDA issuing distinct names.”

A poll taken during the speech revealed that of about 150 pharmacists in the audience, an astonishing 97% supported distinct names:

Regulators are still discussing how best to design a differentiating suffix. The FDA’s first approval, for Zarxio (filgrastim-sndz), used a meaningful suffix “-sndz” reflecting the name of its manufacturer, Sandoz. But the WHO and FDA are both soliciting feedback on proposals to instead use random suffixes, which carry no meaning.

ASBM’s survey revealed that 77% of pharmacists prefer a suffix based on the manufacturer name, with only 15% preferring random suffixes. Similarly, the audience poll showed 77% supporting manufacturer-based suffixes, and 21% preferring random suffixes:

Dr. Schneider’s presentation also addressed the issue of biosimilar labeling– including what information is available to providers on the product insert.

Dr. Schneider emphasized that pharmacists want more information and greater transparency than the FDA currently requires. For example, 81% considered it important for the product to state that it is a biosimilar; 69% considered it important to clearly distinguish data generated by the biosimilar from data generated by the originator product; and 88% considered it important to state whether or not the biosimilar is interchangeable with its reference product.

Later that day, the FDA would release its long-awaited Draft Guidance on Labeling, which begins to address some, though not all, of the respondents’ concerns. For example, while it would identify the product as being biosimilar, it would not distinguish which product- the reference or the biosimilar- generated the safety and efficacy data on the biosimilar label. It also does not address whether the biosimilar is or is not interchangeable with its reference product.

Finally, Dr. Schneider discussed the issue of biosimilar substitution at the state level, including what communication should occur between pharmacist and physician following a substitution:

“Collaboration and communication between pharmacists and physicians is critical to providing effective care. Everyone should know which medicine the patient actually receives, so we can make informed assessments of a patient’s response to a particular treatment.”

Since 2013, 19 states and Puerto Rico have enacted laws which permit pharmacists to substitute biosimilars, provided they communicate to the prescribing physician within a 5-to10-day timeframe which product was dispensed.

The full ASBM Pharmacist Survey results may be read here.