Christine Simmon Senior Vice President, Policy & Strategic Alliances Generic Pharmaceutical Association November 6, 2014 Biologics Naming

Introduction GPhA represents the manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry. 2

Globalization of Naming Drugs have two names, the brand name and the International Nonproprietary Name (INN), one or the other/or both are recognized by patients and clinicians who are the key stakeholders in the value of the name A global system was established by WHO and administered through various regulatory bodies, to make sure drugs with the same active ingredients had a standard International Nonproprietary Name (INN) Naming must be “simple” and “intuitive” to be effective Patient safety and accessibility are best ensured when biologic products shares the same “nonproprietary” name with the original biologic 3

A Biologic has Several Names and Identifiers Identifies Brand Name Product INN Active substance Manufacturer Company National Drug Code (NDC)** Company, product, package Lot number Lot ** NDC is electronically recorded for healthcare professional purview NDC Brand Name INN Manufacturer All trademarks are the property of their respective owners. 4

The INN Identifies the Active Substance (API) The INN is issued by the WHO for; Active substance, NOT product International, NOT country‐specific Non‐proprietary, NOT company‐specific The INN has important roles; Allows doctor and other healthcare professionals to identify an active substance regardless of; (i) which country(s) they currently practices and (ii) which company manufactures the product for that country Allows the global exchange of healthcare information 5

Biologic Naming is a Public Health Issue Consistent “non-proprietary” naming will; Enable globalization Promote biosimilar intent to drive cost savings Ensure robust market formation Maximize reimbursement and product adoption Support pharmacovigilance systems Reduce confusion of clinicians and patients Build off of a successful foundation of the same INN for both generic and brand name small molecules Biosimilar products have been in the European market since 2006/2007 and have had the same INN The biosimilar monoclonal antibody (mAb) products Remsima® and Inflectra® were approved by the EMA using the same INN as the reference product (infliximab) 6

Key Principles to Product Identification GPhA continues to support the same INN  Adding more complexity to current naming is NOT recommended as it will neither increase compliance nor reduce confusion If needed, GPhA would consider an additional, unattached qualifier;  Independent of INN  Includes the full company name of the marketing authorization holder  On the same line as the INN, but separate/unattached from the INN o INN: epoetin alfa o Unique Identifier: Epoetin alfa Sandoz  Applicable to ALL biologic products, not just biosimilars  Applied retroactively WHO INN Program is considering a unique identifier  BQXXXX – which identifies to the manufacturing site level  GPhA does not support this construct, nor does FDA 7

Manufacturers that intend to market their pharmaceutical in the US are also required to request a United States Adopted Name (USAN) The USAN Council is comprised of members from the American Medical Association (AMA), American Pharmacists Association (APhA), U.S. Pharmacopeial Convention (USP), and the FDA. The USAN Council selects “simple, informative and unique nonproprietary names for drugs by establishing logical nomenclature classification based on pharmacological and/or chemical relationships”. 1 The USAN process is independent of the WHO INN process A USAN must be accepted by the USAN Council, the INN Expert Group, and the sponsor prior to the USAN being adopted. United States Adopted Names 8 1. Source: usan.page? usan.page

Non-unique Naming GPhA’s Biosimilars Network remains active and has participated in a series of meetings with bipartisan congressional staff to discuss biosimilars naming. Biosimilars Network members include companies from the following categories: – Payers – Pharmaceutical Benefit Managers (PBMs) – Retail Pharmacies – Labor Unions – Public Employee Retirement Systems Unique Naming Patients for Biologics Safety & Access – Coalition of more than 20 patient advocacy organizations encouraging unique INNs for biosimilars Biosimilars Naming – Advocacy Efforts 9

Biosimilars are expected to save the health care system billions of dollars. The magnitude of savings will depend on a variety of factors, including but not limited to FDA’s final biosimilars regulations on naming, substitution, and interchangeability. Savings estimates range from $44 billion 1 to $250 billion 2 over a ten year period. Cost Saving Potential of Biosimilars 10 1."The Cost Savings Potential of Biosimilar Drugs in the United States.” Andrew W. Mulcahy, Zachary Predmore, and Soeren Mattke. RAND Corporation. November Available at: “The $250 Billion Potential of Biosimilars. Express Scripts. April Available at: updates/the-$250-billion-potential-of-biosimilarshttp://lab.express-scripts.com/insights/industry- updates/the-$250-billion-potential-of-biosimilars

Questions? 11