Biosimilar Regulatory Issues Review of Pharmacy Organizations’ Policy Statement Joint Commission of Pharmacy Practitioners Meeting January 16, 2019

List of Organizations American Pharmacists Association (APhA) Academy of Managed Care Pharmacy (AMCP) American Society of Consultant Pharmacists (ASCP) American Society of Health-System Pharmacists (ASHP) Hematology/Oncology Pharmacy Association (HOPA) National Association of Boards of Pharmacy (NABP) Model Pharmacy Practice Act National Association of Chain Drug Stores (NACDS) National Community Pharmacist (NCPA)

Organizations’ Policy Statement Policy Area FDA Guidance and Regulatory Activity Policy Statement Use of biosimilar The Biologics Price Competition and Innovation Act of 2009 established an abbreviated licensure pathway for biological products. All organizations, except for ASCP and NABP that do not have a statement, support the use of biosimilars. Naming Under the FDA’s final guidance on Nonproprietary Naming of Biological Products in 2017, each originator biological product, related biological product, and biosimilar product will be identified by a proper name with two parts: (1) a core name and (2) a four-letter suffix with devoid meaning. No guidance is currently available for a naming convention for interchangeable products. All organizations, except for NABP that does not have a statement, advocate for the use of the reference product’s core name for the biosimilar products. HOPA supports the use of a meaningful four-letter suffix for FDA-designated non-interchangeable biosimilars.

FDA Guidance and Regulatory Activity Policy Area FDA Guidance and Regulatory Activity Policy Statement Labeling Under the FDA’s final guidance on Labeling for Biological Products in 2018, biosimilar products labeling should incorporate relevant safety and effectiveness data from the reference product labeling. FDA recommends a specified biosimilarity statement of the biosimilar product to the reference product’s indication(s) in the “Highlights” section. Labeling recommendations for interchangeable products will be provided in the future. APhA, AMCP and HOPA support the use of the same content found in the reference product’s label, including the clinical data supporting the reference product, for the biosimilars’ label. AMCP believes including a statement describing that the product was approved as a biosimilar product may discourage use of biosimilars. APhA also identifies the need for product labeling and information related to the interchangeable products.

FDA Guidance and Regulatory Activity Policy Area FDA Guidance and Regulatory Activity Policy Statement Pharmacy-level substitution According to the section 351(i)(3) of the Public Health Service Act, interchangeable products may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product. In contrast, biosimilar products are specifically prescribed and cannot be substituted at the pharmacy level. The state laws that address substitution of biological products at the pharmacy level vary from state to state. All organizations, except ASCP, NABP that do not have a statement, advocate for the substitution of biological without the intervention of prescribers, similarly to the process of generic product selection. HOPA recommends that the development of future biosimilar substitution legislation should have the input from the State’s Board of Pharmacy, local pharmacy organizations, and other healthcare providers.

FDA Guidance and Regulatory Activity Policy Area FDA Guidance and Regulatory Activity Policy Statement Pharmacy requirements for substitution As of 2018, 45 states and Puerto Rico have enacted state law and legislation on biosimilar substitution requirements. Some general requirements are prescriber/patient notification and pharmacy recordkeeping. APhA, AMCP, and ASHP oppose the unnecessary state requirements that place excess burden on pharmacists or other practitioners when an FDA-licensed interchangeable product is dispensed. Extrapolation for indications of biosimilars Under the FDA’s guidance on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product in 2015, a biosimilar product may be approved for a reference product’s indication without direct studies by extrapolation. APhA, AMCP, and HOPA support the conceptual framework of extrapolation in approving biosimilars for the reference product’s clinical indications.

FDA Guidance and Regulatory Activity Policy Area FDA Guidance and Regulatory Activity Policy Statement Biological product resource The FDA’s Purple Book is an electronic list of FDA-licensed innovator biological products, as well as any biosimilar and interchangeable biological products. It includes the licensed issue date, reference product exclusivity, and biosimilar or interchangeability evaluations. APhA determined that the Purple Book was the only legitimate resource in the United States for information on biosimilar products. HOPA and NACDS encouraged FDA to create a reference like the Orange Book to compare a biosimilar product to the reference product.

Summary of Available Policy Statements Policy Area APhA AMCP ASCP ASHP HOPA NABP NACDS NCPA Use of biosimilars ✓   Naming Labeling Pharmacy-level substitution Pharmacy requirements for substitution Extrapolation for indications of biosimilars Biological product resource Table: Summary of the available policy statements from professional pharmacy organizations on different policy areas of biosimilar and biological products