Posts – Page 45 – Safe Biologics

ASBM Presents to Rhode Island Pharmacists

April 1, 2016

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.

ASBM Presents to Rhode Island Pharmacists

April 1, 2016

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.

ASBM Presents to Louisville Patients, Physicians, Health Professionals

March 25, 2016

On March 24^th, in Louisville, KY, ASBM presented a one hour program entitled “Biosimilars: New Choices, New Challenges”, on the benefits and challenges which will accompany the arrival of biosimilars to the U.S. healthcare landscape. The event was held at the University of Louisville’s Kosair Charities Clinical & Translational Research Facility, and the audience consisted of patients, physicians, medical students, and other health professionals.

The first presentation, by Chairman Harry L. Gewanter, MD focused on the perspectives of healthcare providers such as physicians who prescribe biosimilars and pharmacists who dispense them. Dr. Gewanter shared survey data which showed strong support among these groups for distinguishable naming of biosimilars. Also important was informative, transparent labeling that helps them provide informed advice to their patients. Dr. Gewanter also emphasized the need for collaboration and communication between providers, particularly in the case of a potential biosimilar substitution.

View Dr. Gewanter’s presentation here.

The second presentation was from ASBM Advisory Board Member and Executive Director of the Global Colon Cancer Association, Andrew Spiegel. Mr. Spiegel’s presentation focused on the patient’s perspective on biosimilars.

Mr. Spiegel spoke of his great enthusiasm about the coming of biosimilars, which will increase access to the biologic therapies that are extending and improving the lives of millions of patients. But he also cautioned that governments and insurers are under great cost pressures, and that policymakers must always keep patient safety as their primary focus when approving and regulating biosimilars.

View Mr. Spiegel’s presentation here.

ASBM Educates St. Louis Patients, Healthcare Providers

March 24, 2016

On March 23^rd, ASBM conducted an hour-long presentations entitled “Biosimilars: New Choices, New Challenges” for a group of patients and healthcare providers in St. Louis, MO.The presentation was given at a hospital complex in downtown St. Louis which includes Barnes Jewish Hospital St. Louis Children’s Hospital and Shriner’s Hospital for Children.

The program began with ASBM Chairman Harry L. Gewanter, MD outlining for attendees the basic science of biologics and biosimilars, including the differences between biosimilars and chemical generics. Dr. Gewanter then provided a physician’s perspective on issues such as the need for distinguishable naming of biologics, and the need for pharmacist-physician communication in the event of a biosimilar substitution.

Following Dr. Gewanter was ASBM Advisory Board Chair, University of Arizona professor of pharmacy Philip Schneider, who provided a pharmacist perspective on biosimilars. Dr. Schneider also emphasized clear product identification as critical for biologics, including biosimilars, referencing survey data showing support among pharmacists for distinct names. Dr. Schneider also examined the issue of biosimilar labeling, citing survey data that show many providers want more transparent and informative labeling than is currently required by the FDA. Finally, he outlined how many states, including Missouri, are crafting biosimilar substitution legislation that addresses the need for physician-pharmacist communication.

The final presentation was from ASBM Steering Committee member Andrew Spiegel of the Global Colon Cancer Association, who provided a patient’s perspective. Mr. Spiegel expressed optimism about the new choices and lower costs biosimilars will provide. Yet he stressed the need to maintain transparency in their approval process, and to keep treatment decisions- including the decision to switch- the purview of physician and patient rather than a third party.

ASBM Educates St. Louis Patients, Healthcare Providers

March 24, 2016

On March 23^rd, ASBM conducted an hour-long presentations entitled “Biosimilars: New Choices, New Challenges” for a group of patients and healthcare providers in St. Louis, MO.The presentation was given at a hospital complex in downtown St. Louis which includes Barnes Jewish Hospital St. Louis Children’s Hospital and Shriner’s Hospital for Children.

The program began with ASBM Chairman Harry L. Gewanter, MD outlining for attendees the basic science of biologics and biosimilars, including the differences between biosimilars and chemical generics. Dr. Gewanter then provided a physician’s perspective on issues such as the need for distinguishable naming of biologics, and the need for pharmacist-physician communication in the event of a biosimilar substitution.

Following Dr. Gewanter was ASBM Advisory Board Chair, University of Arizona professor of pharmacy Philip Schneider, who provided a pharmacist perspective on biosimilars. Dr. Schneider also emphasized clear product identification as critical for biologics, including biosimilars, referencing survey data showing support among pharmacists for distinct names. Dr. Schneider also examined the issue of biosimilar labeling, citing survey data that show many providers want more transparent and informative labeling than is currently required by the FDA. Finally, he outlined how many states, including Missouri, are crafting biosimilar substitution legislation that addresses the need for physician-pharmacist communication.

The final presentation was from ASBM Steering Committee member Andrew Spiegel of the Global Colon Cancer Association, who provided a patient’s perspective. Mr. Spiegel expressed optimism about the new choices and lower costs biosimilars will provide. Yet he stressed the need to maintain transparency in their approval process, and to keep treatment decisions- including the decision to switch- the purview of physician and patient rather than a third party.

ASBM Submits Comments on Health Canada SEB Guidance

February 16, 2016

On February 15th, ASBM submitted comments to Health Canada on its December 7th Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars), for which Health Canada has sought comment from stakeholders.

The Guidance calls for more labeling transparency than is currently required by the FDA. For example, the SEB sponsor must include data they generate on the product’s label and must provide safety data for all indications.

The Guidance Document and information on submitting feedback may be found here.

ASBM Submits Comments on Health Canada SEB Guidance

February 16, 2016

On February 15th, ASBM submitted comments to Health Canada on its December 7th Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars), for which Health Canada has sought comment from stakeholders.

The Guidance calls for more labeling transparency than is currently required by the FDA. For example, the SEB sponsor must include data they generate on the product’s label and must provide safety data for all indications.

The Guidance Document and information on submitting feedback may be found here.

FDA Advisory Panel Recommends Approval of Biosimilar Infliximab

February 10, 2016

On February 9th, the FDA’s Arthritis Advisory Committee held a hearing on CT-P13, a biosimilar to infliximab marketed internationally as Remsima or Inflectra.

Infliximab is approved to treat conditions including Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriasis (Pso), Crohn’s Disease (CD) and Ulcerative Colitis (UC). This would be the first biosimilar for a monoclonal antibody (MAb) approved by the FDA.

ASBM Chairman Harry Gewanter MD noted that many physician and patient groups have raised concerns about approving CT-P13 for IBD indications (CD and UC) based on data from RA and AS, due to different mechanisms of action.

For these reasons, Health Canada did not approve CT-P13 for UC and CD. Nevertheless, the AAC voted 21-3 to approve CT-P13 for all indications of its reference product.

Any indications for which FDA approval was based on extrapolation should be clearly identified on a biosimilar’s label, Dr. Gewanter cautioned, so that physicians can make informed decisions and can have confidence in biosimilars.

Dr. Gewanter’s remarks may be read here , and ASBM’s written testimony read here.

FDA Advisory Panel Recommends Approval of Biosimilar Infliximab

February 10, 2016

On February 9th, the FDA’s Arthritis Advisory Committee held a hearing on CT-P13, a biosimilar to infliximab marketed internationally as Remsima or Inflectra.

Infliximab is approved to treat conditions including Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriasis (Pso), Crohn’s Disease (CD) and Ulcerative Colitis (UC). This would be the first biosimilar for a monoclonal antibody (MAb) approved by the FDA.

ASBM Chairman Harry Gewanter MD noted that many physician and patient groups have raised concerns about approving CT-P13 for IBD indications (CD and UC) based on data from RA and AS, due to different mechanisms of action.

For these reasons, Health Canada did not approve CT-P13 for UC and CD. Nevertheless, the AAC voted 21-3 to approve CT-P13 for all indications of its reference product.

Any indications for which FDA approval was based on extrapolation should be clearly identified on a biosimilar’s label, Dr. Gewanter cautioned, so that physicians can make informed decisions and can have confidence in biosimilars.

Dr. Gewanter’s remarks may be read here , and ASBM’s written testimony read here.

House Energy & Commerce Committee Holds Hearing on Biosimilars

February 5, 2016

On February 4, the House Energy and Commerce Health Subcommittee held a hearing to discuss implementation of the Biologics Price Competition and Innovation Act (BPCIA).

Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare at the Centers for Medicare and Medicaid Services (CMS), and Janet Woodcock, the Director of the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA), offered testimony at this hearing.

Members of the committee expressed frustration over the FDA’s delay in releasing guidances on interchangeability, naming, labeling, and extrapolation. Dr. Woodcock said that the FDA should be issuing draft guidances on interchangeability, naming, and labeling this year. She noted that the agency will continue to review and approve biosimilar applications regardless of whether or not the guidances have been issued.

Committee members were concerned that CMS’ biosimilar reimbursement policy would stifle innovation. ASBM has previously expressed concern with this rule; read ASBM’s comment letter here.