January 2017 Newsletter
January 7, 2017
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What a Difference a Year Makes!
November 18, 2016
Philip J. Schneider, MS FASHP
Associate Dean, University of Arizona College of Pharmacy
ASBM Advisory Board Chair
This past weekend it was my honor to participate in a continuing education course for 100 New York pharmacists on the topic of biologic medicines and biosimilars, including safety and regulatory considerations which affect pharmacy practice. The 5-hour course was held in partnership with the Long Island University College of Pharmacy (LIU-Pharmacy) and was an update to a similar course ASBM and LIU presented last year. You may read about this latest course in-depth here.
While preparing for the course, I was struck at how rapidly the biologic/biosimilar policy environment is changing, relative to many areas of pharmacy practice which are largely settled (such as the substitution practices regarding generic versions of chemical drugs). This makes biologic/biosimilar policy both a exciting subject on which to teach, and a critical subject on which a practicing pharmacist needs to educate himself or herself!
For example, when we first taught this course in March of 2015, the FDA had approved its first biosimilar, Zarxio (filgrastim-sndz) only a week earlier. Today, there are four approved biosimilars in the U.S., with more on the way.
When we last met, there was no formal biosimilar naming policy in place. Zarxio (filgrastim-sndz) used a distinguishing suffix based on its manufacturer’s name (Sandoz=sndz) at the request of the manufacturer, which felt random suffixes “didn’t make sense.” Yet in August 2015, the FDA issued Draft Guidance on Naming, which proposes a shift to random suffixes (similar to the system proposed by the World Health Organization), and the three most recent approvals currently follow this convention.
Debate continues on the relative merits of each system, but it remains ASBM’s position that memorable, meaningful suffixes are preferable for making products clearly distinguishable for one another. Pharmacists in particular have a long history of wanting to avoid look-alike or sound-alike names for different medicines, and indeed subsequent research by ASBM and others since the last course has shown that most pharmacists share this preference for meaningful suffixes.
Likewise, last year we spoke about the product labeling of Zarxio, and how it had raised several concerns among physicians, who like pharmacists rely on product inserts to advise patients on potential adverse events or help them choose between similar medicines. (In September 2015, ASBM surveyed 401 U.S. pharmacists and found they too share these concerns):
For example, the product did not identify itself as a biosimilar, or state to which product it was similar. (Biosimilars, unlike generics, are not identical to their reference products and may or may not be approved for- or may not have been evaluated in- the same indications as the originator. An identification that the product is a biosimilar would thus serve as an instant flag to a physician or pharmacist that it might not be approved to treat a particular condition.) The labeling did not state whether or not the biosimilar is interchangeable with its reference product (and would thus be substitutable by a pharmacist).
In March 2016, the FDA released Draft Labeling Guidance which has addressed some, though not all of these concerns, and discussion continues on how to craft more transparent, informative labeling that helps providers use biosimilars with confidence:
Another example: biosimilar substitution laws. At last year’s course, here is the map of the 12 states, shown in green, which permitted pharmacists to substitute an interchangeable biosimilar in place of the reference product, provided they communicate to the prescribing physician which product was dispensed:
And here’s that map today. The number of “green” states has more than doubled, from 12 states then to 25 and Puerto Rico today, due in some part to feedback from pharmacists, which has led to improved legislation:
And so biosimilar policy is rapidly evolving- as regulators, pharmacists, physicians, and patients educate themselves, listen to one another’s concerns, and then work collaboratively to address these and other policy challenges so these medicines can be brought safely to patients.
Who knows what further progress we’ll have made by next year’s course?
What a Difference a Year Makes!
November 18, 2016
Philip J. Schneider, MS FASHP
Associate Dean, University of Arizona College of Pharmacy
ASBM Advisory Board Chair
This past weekend it was my honor to participate in a continuing education course for 100 New York pharmacists on the topic of biologic medicines and biosimilars, including safety and regulatory considerations which affect pharmacy practice. The 5-hour course was held in partnership with the Long Island University College of Pharmacy (LIU-Pharmacy) and was an update to a similar course ASBM and LIU presented last year. You may read about this latest course in-depth here.
While preparing for the course, I was struck at how rapidly the biologic/biosimilar policy environment is changing, relative to many areas of pharmacy practice which are largely settled (such as the substitution practices regarding generic versions of chemical drugs). This makes biologic/biosimilar policy both a exciting subject on which to teach, and a critical subject on which a practicing pharmacist needs to educate himself or herself!
For example, when we first taught this course in March of 2015, the FDA had approved its first biosimilar, Zarxio (filgrastim-sndz) only a week earlier. Today, there are four approved biosimilars in the U.S., with more on the way.
When we last met, there was no formal biosimilar naming policy in place. Zarxio (filgrastim-sndz) used a distinguishing suffix based on its manufacturer’s name (Sandoz=sndz) at the request of the manufacturer, which felt random suffixes “didn’t make sense.” Yet in August 2015, the FDA issued Draft Guidance on Naming, which proposes a shift to random suffixes (similar to the system proposed by the World Health Organization), and the three most recent approvals currently follow this convention.
Debate continues on the relative merits of each system, but it remains ASBM’s position that memorable, meaningful suffixes are preferable for making products clearly distinguishable for one another. Pharmacists in particular have a long history of wanting to avoid look-alike or sound-alike names for different medicines, and indeed subsequent research by ASBM and others since the last course has shown that most pharmacists share this preference for meaningful suffixes.
Likewise, last year we spoke about the product labeling of Zarxio, and how it had raised several concerns among physicians, who like pharmacists rely on product inserts to advise patients on potential adverse events or help them choose between similar medicines. (In September 2015, ASBM surveyed 401 U.S. pharmacists and found they too share these concerns):
For example, the product did not identify itself as a biosimilar, or state to which product it was similar. (Biosimilars, unlike generics, are not identical to their reference products and may or may not be approved for- or may not have been evaluated in- the same indications as the originator. An identification that the product is a biosimilar would thus serve as an instant flag to a physician or pharmacist that it might not be approved to treat a particular condition.) The labeling did not state whether or not the biosimilar is interchangeable with its reference product (and would thus be substitutable by a pharmacist).
In March 2016, the FDA released Draft Labeling Guidance which has addressed some, though not all of these concerns, and discussion continues on how to craft more transparent, informative labeling that helps providers use biosimilars with confidence:
Another example: biosimilar substitution laws. At last year’s course, here is the map of the 12 states, shown in green, which permitted pharmacists to substitute an interchangeable biosimilar in place of the reference product, provided they communicate to the prescribing physician which product was dispensed:
And here’s that map today. The number of “green” states has more than doubled, from 12 states then to 25 and Puerto Rico today, due in some part to feedback from pharmacists, which has led to improved legislation:
And so biosimilar policy is rapidly evolving- as regulators, pharmacists, physicians, and patients educate themselves, listen to one another’s concerns, and then work collaboratively to address these and other policy challenges so these medicines can be brought safely to patients.
Who knows what further progress we’ll have made by next year’s course?
ASBM Conducts CE Course for 100 NY Pharmacists
November 14, 2016
On November 13th, ASBM conducted a 5-hour Continuing Education (CE) course for 100 New York pharmacists in Queens, NY.
The course, entitled “Biosimilars and Biologics- Regulatory and Practice Issues for Pharmacists” was presented in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy). The course was a follow-up to the 5-hour course ASBM and LIU-Pharmacy presented in March 2015. Participating pharmacists earned 5 hours of CE credit from the New York State Board of Pharmacy.
“Biosimilar policy is a rapidly-changing area of healthcare, said ASBM Advisory Board Chair Philip Schneider. “When we presented this course last year, the FDA had approved its first biosimilar just one week prior. Since then, three more have been approved, the FDA has issued Draft Guidance on both Naming and Labeling, and the number of states permitting biosimilar substitution has more than doubled. It’s important for pharmacists to stay informed.”
Topics covered included the basics of biologic medicines and biosimilars, how differences between biosimilars and chemical generics affect pharmacy practice, and a discussion of laws and regulations relevant to pharmacists regarding biosimilar approval, naming, substitution, and labeling.
Below are descriptions of and links to each presentation:
1) Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Effects
Philip Schneider, MS FASHP
ASBM Advisory Board Chair
Associate Dean of the University of Arizona College of Pharmacy
Past president of the American Society of Health-system Pharmacists (ASHP)
In this presentation, Dean Schneider begins by explaining what biologic medicines are, how they were developed and approved, and how they are used to treat serious conditions including rheumatoid arthritis and cancer. He then explains safety, storage and handling considerations that result from the greater size, complexity, and sensitivity of biologics, relative to small molecule drugs.
He follows with a discussion of biosimilars, discussing differences between biosimilars and chemical generics- chief among them that biosimilars are not identical but only similar to their reference products. Schneider then examines the need for clear product identification with biologic medicines, including biosimilars, and shares perspectives from regulators, national pharmacist organizations, and surveys of pharmacists regarding possible naming conventions for biosimilars.
View Dr. Schneider’s presentation here.
2) Physician Perspectives on Biosimilars
Michael S. Reilly, Esq.
Executive Director, Alliance for Safe Biologic Medicines
Mr. Reilly begins by discussing the formation and functions of ASBM and gives an overview of the current policy landscape, highlighting three key issues on which he will share physician perspectives: biosimilar naming, substitution, and labeling. He discusses how ASBM’s surveys of physicians in 12 countries has revealed a need for education about biosimilars, as well as a need for distinct names for all biologics, including biosimilars.
For example, large percentages of physicians refer to biologics only by their International Nonproprietary Names (INN) when recording in the patient record (which could result in the patient recieving the wrong medicine) or when reporting adverse events (which could result in misattribution to the wrong product).
Mr. Reilly then discussed ASBM’s role in the development of a solution to this problem: a proposal by the World Health Organization to modify the INN system by adding a four-letter suffix called a Biological Qualifier (BQ). The BQ is potentially compatible with the FDA’s naming guidance, released in August 2015. Reilly then presented data showing broad support for distinct naming among physicians in Canada, U.S. and Latin America.
Regarding substitution, surveys revealed that it is important to physicians to be informed in the event a biosimilar is substituted at the pharmacy, and to retain the authority to block a substitution. Reilly then discussed labeling requirements for biosimilars in the U.S., and showed data from ASBM surveys of physicians and pharmacists which revealed a desire for greater transparency and information that currently required by the FDA.
View Mr. Reilly’s presentation here.
3) Biosimilars: The Patient Perspective
Andrew Spiegel, Esq.
Executive Director, Global Colon Cancer Association
Mr. Spiegel spoke about his experience as a patient advocate following the death of his parents from cancer. Today, he explained, the life expectancy of patients diagnosed with colon cancer has tripled, in part due to biologic medicines. Biosimilars, Mr. Spiegel emphasized, hold great promise for patients- offering new therapeutic options and doing so at lower cost. However, he cautioned that the benefits of biosimilars will not be realized unless they gain the confidence of providers and patients.
Mr. Spiegel discussed Non-Medical Switching. The choice to use an innovator biologic or biosimilar, must always be made by the patient and physician, rather than a third-party payer.
“Treatment decisions, including the decision to switch from one medicine to another should be made for medical reasons that benefit the health and safety of the patient, not for non-medical reasons that might benefit a a company’s shareholders”, said Spiegel. He then outlined practices that payers may use to force a patient to switch to a non-interchangeable biosimilar, such as changing their medical coverage or health care premiums.
Mr. Spiegel also described his experience at recent FDA hearings, where committee members were given an “all or nothing” choice: approve a biosimilar for all the diseases it seeks approval to treat (or indications) for which it applied, or none at all. By contrast, in Canada, biosimilars are approved for each indication separately. The FDA’s “all or nothing” approach is worrying, and does not serve the interest of patients, Mr. Spiegel argued.
Pharmacists, Spiegel said, serve an important role in patient care and should be well-informed by transparent, informative product labeling regarding a biosimilar’s approval, especially regarding indication extrapolation: “Pharmacists are the last line of defense for patients, the last link in the chain…they should give informed advice to patients about the benefits of biosimilars, as well as helping track possible adverse events.”
View Mr. Spiegel’s presentation here.
4) Biosimilars: A Regulatory Overview
Bruce Babbitt, PhD
Vice President – Technical (Drug Development & Regulatory Affairs), PAREXEL Consulting
In this presentation, Dr. Babbitt begins by listing many biologics for which biosimilars are currently in development.
He then outlines the current regulatory environment surrounding biosimilar approvals. He begins with a regulatory history of the U.S. biosimilars pathway, which has its origins in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which laid the framework for U.S. biosimilar development. Dr. Babbitt discusses the definition of biosimilarity set by the BPCIA, and outlines how the totality of clinical and non-clinical evidence is used by the FDA to determine biosimilarity.
Dr. Babbitt then examines in detail how biosimilars are evaluated, including trial design, biosimilar trial recruitment challenges, PK and PD studies, factors that impact immunogenicity, and clinical considerations. Finally, he discusses the evaluation and approval of the four biosimilars currently approved for sale in the U.S. by the FDA.
5) Pharmacists and Biosimilars: Impact of Naming Conventions and Notification on Substitution
Daniel Tomaszewski, RPh, Phd
Assistant Professor in Pharmacy Administration, Chapman University
In this presentation, Dr. Tomaszewski discusses the potential benefits of biosimilar use in pharmacy practice relative to the “Triple Aim”, three core values identified by Donald Berwick and Thomas Nolan in 2007 to guide improvement in U.S. healthcare system. The Triple Aim consists of 1) Improving Health, 2) Improving Care, and 3) Reducing Costs. The use of safe and effective biosimilars, Dr. Tomaszewski argued, would effect positive change in each of these three areas.
Improved collaboration and good communication between providers is another means of improving healthcare outcomes and reducing cost. Dr. Tomaszewski cited work by NEHI and RWJF which shows a potential for $21 billion in savings due to improved communication and collaboration, which would reduce medication errors. Preventable medication errors, the NEHI and RWJF study found, 3.3 million additional outpatient visits, and 3.3 million additional inpatient admissions, and 7,000 deaths annually. He then highlighted several other areas in which pharmacists could be be engaged to a greater degree in a patient’s healthcare team, resulting in better care and increased savings.
Finally, Dr. Tomaszewski discussed a recently published whitepaper he authored, regarding pharmacist preferences on biosimilar naming. The whitepaper was based on a 2015 survey of 781 respondents selected from the membership of the Hematology and Oncology Pharmacy Association (HOPA) and the Acadaemy of Managed Care Pharmacy (AMCP).
Respondents were very supportive of distinct naming, with 74% supporting distinct names, with the most-preferred method being INN plus suffix (48%) as proposed by the WHO and FDA. The study also attempted to measure the percieved burden of communication requirements following biosimilar substitution, and their impact, if any, on the likelihood of substitution.
While 41.5% agreed there would be “some burden”, 23% felt this burden would be substantial. However, a similar percentage (24%) felt there would be no burden (6%) or a minimal burden (18%). Regarding the impact of these requirements, 44% felt there would be no impact, 28% felt they would be less likely to dispense biosimilars, and 24% were unsure of the impact.
View Dr. Tomaszewski’s presentation here.
6) Biosimilar Substitution: A Collaborative Approach to Pharmacovigilance
Philip Schneider, MS FASHP
ASBM Advisory Board Chair
Associate Dean of the University of Arizona College of Pharmacy
Past president of the American Society of Health-system Pharmacists (ASHP)
The final presentation of the day was given by Dr. Schneider, and dealt with biosimilar substitution policy in the United States. Dean Schneider emphasized that while Congress sets the legal definition of interchangeability, and the FDA makes the scientific determination of which biosimilars are interchangeable, it is the individual States that govern when and how a pharmacist can substitute and interchangeable biosimilar.
Following a brief discussion about substitution policy globally (including Canada, the EU, Latin America, and Australia) Dr. Schneider spoke about the evolution of biosimilar substitution legislation in the US. He focused his discussion on laws passed by 25 states and Puerto Rico which require a pharmacist to communicate to the prescribing physician which product- the originator or the biosimilar- was actually dispensed to the patient. These states also allow a physician to specify “do not substitute” or “dispense as written” in order to prevent a substitution they consider medically inappropriate.
A collaborative and communicative approach to pharmacovigilance, Schneider argued, is good for everyone. It empowers the pharmacist to offer the patient new and lower-cost treatment options, it allows the patient to be an engaged partner in a their own care, it allows the physician to maintain an accurate patient record and make informed treatment decisions, and it improves safety overall by promoting accurate attribution of adverse events to the proper medicine.
View Dr. Schneider’s presentation here.
The course ended with a Q&A period and post-course learning assessment questions.
November 2016 Newsletter
November 7, 2016
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November 2016 Newsletter
November 7, 2016
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One of These is Not Like the Other …
November 7, 2016
Harry L. Gewanter, MD, FAAP, FACR
Chairman, ASBM
Since becoming involved with ASBM on the Medical Advisory Board and, more recently, as Chairman, I’ve learned a great deal about biosimilars. Being a pediatrician, I have found that analogies are an extraordinarily helpful means to explain complex issues. This video has proven to be an invaluable teaching tool when discussing the benefits and challenges of these medications:
They are not the same. They may be close, but they are not the same. Cookie Monster has hit the nail on the head.
Biosimilars may be highly similar to their reference products, but they are not the same. This is in contrast to generic versions of chemical medications which are identical. Being a reverse-engineered molecule designed to mimic the therapeutic properties of the originator, they may be close, but they are still not the same. While we hope and expect that these new molecules will behave in the same way as the originator molecule, there may be unexpected differences, such as unwanted immune responses.
The reality that biosimilars are close, but not the same as the originator molecules is at the core of the challenges faced by regulators, physicians, pharmacists and patients. Here are but a few of the various issues that must be reconciled if we are to reap the full potential benefits of these medications:
Approval: Biosimilars need to demonstrate that they are not only similar analytically, but that they also function similarly to their reference product. How much clinical data is needed and in how many conditions are sufficient to demonstrate this high similarity remains a subject of debate.
Naming: All biologic medications (both originators and biosimilars) must be clearly distinguished from one another in order to accurately track any benefits or problems to the correct product. The global use of these miracle biologic medications calls for a worldwide agreement on their names. Both the FDA and WHO have made distinct naming a priority, but have yet to announce an “official” system.
Labeling: Transparent, informative labeling assists physicians and patients to make more informed treatment decisions when choosing between similar products. Knowing if a product is the originator or a biosimilar or for what conditions each product has clinical data versus an extrapolated approval are two examples of important information that should be on a label. Labeling regulations vary from country to country, with Canada’s policies currently requiring the greatest degree of transparency.
Substitution: Physicians and patients need to know which product – the originator or the biosimilar – was dispensed by the pharmacy in order to accurately assess the medication’s effects. While no products are currently interchangeable in the United States, the potential for non-medical substitution exists.
Notification: A majority, but not all U.S. states have enacted laws requiring communication between pharmacists and prescribers if a biosimilar is dispensed when not specifically prescribed. How this communication is to be performed and within what time frame varies from state to state.
Put simply, as any preschooler – or muppet – knows, differences matter.
Physicians, pharmacists and patients are appropriately leery of using medications for which they may not have sufficient data or knowledge of the potential variations. To fully realize the potential benefits of biosimilars – such as improved access, additional treatment choices and lower costs – policies at all levels needs to reflect that reality.
ASBM Participates in AusBiotech 2016 Conference
October 26, 2016
During the last week of October, ASBM participated in the AusBiotech 2016 conference, which ran from the 24th-26th in Melbourne, Australia. The event attracted more than 2000 attendees, including Australian regulators, physicians, patients, researchers and biologic manufacturers.
Andrew Spiegel, executive director of the Global Colon Cancer Association, an ASBM Steering Committee member, represented ASBM at the conference.
Mr. Spiegel staffed ASBM’s booth, met with many attendees, including officials from the Australian Therapeutic Goods Administration (TGA); and, shared ASBM’s positions on issues relevant to Australia such as distinct naming and pharmacy-level substitution.
More information on Australian biosimilars policy may be found here.
ASBM Member Testifies in Support of BsUFA Reauthorization
October 20, 2016
On October 20th, representatives from the patient, physician, and pharmacist communities joined manufacturers of innovator biologics and biosimilars to discuss reauthorization of the Biosimilars User Fee Act (BsUFA). BsUFA is a five-year agreement between FDA and stakeholders that finances the FDA’s review of biosimilars through fees paid by biosimilar sponsors. It is set to expire in September 2017. The public meeting was held to discuss BsUFA’s proposed replacement, BsUFA II, at the FDA’s campus in Silver Spring, MD.
ASBM Steering Committee member group, the Global Colon Cancer Association, represented ASBM at the meeting. GCCA head Andrew Spiegel praised BsUFA’s track record in his remarks:
As patient advocates, we are extremely encouraged by the success of BsUFA in promoting both the safe and timely introduction of biosimilars. We’ve finally seen several biosimilars approved over the past year; and numerous other products are in various stages of the pipeline.
We can see the FDA’s cautious, science-based approach to biosimilar approval is working: take for example its use of distinguishable naming–both in the Zarxio approval and in subsequent approvals. It is critical for patients and providers to always be able to clearly identify which biologic product is being used throughout treatment. Accurate attribution of adverse events to the correct biologic is also necessary for long-term tracking of safety and efficacy.
Learn more about BsUFA II here.
Read Mr. Spiegel’s remarks here.
Click here to watch the full FDA Meeting.
ASBM Presents to WHO at 63rd INN Meeting
October 19, 2016
On October 18th, in Geneva, Switzerland, ASBM President Doug Badger and Advisory Board Chair Philip Schneider, MS, FASHP participated in the World Health Organization’s 63rd Stakeholder Consultation on International Nonproprietary Names.
The subject of the INN meeting is the continued development of the INN Programme’s Biologic Qualifier (BQ) proposal. The is a modification to the INN system designed to ensure clear product identification between biosimilars and their reference product by means of a four-letter distinguishing suffix appended to a common root name. This is the eighth INN Consultation at which ASBM has shared its perspectives with the INN Expert Group.
As a condition of participation, ASBM was asked by the WHO to refrain from discussing details about the meeting until the Executive Summary is made available to the public in the coming months.
The Executive Summary from the 62nd INN Consultation, held on April 12th, may be viewed here, and ASBM’s presentation from that meeting may be viewed here.
