Safe Biologics

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 Since then, three more have been approved, the FDA has issued Draft Guidance on both Naming and Labeling, and the number of states permitting biosimilar substitution has more than doubled.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.