U.S. BIOPHARMACOPEIA Registry of Biopharmaceutical and Biogeneric, Biosimilar, Follow-on Protein and Biologics, etc., Products (Nomenclature)

U.S. BIOPHARMACOPEIA Registry of Biopharmaceutical Products

Biosimilars/follow-on proteins/biogenerics are coming! This raises a number of issues that must be resolved concerning how to define the most basic aspects and nomenclature (naming) of biopharmaceutical products. Before one can regulate these products based on relationships between them, one must be able to define what is a distinct/unique biopharmaceutical (which is much harder than determining biosimilarity between products). What is a 'biopharmaceutical' (or whatever synonym one prefers)? And what is a biosimilar/follow-on biologic/biogeneric? What changes in an active agent or finished product require defining, naming and tracking it as a new, different product (when does a reference product become a new one, e.g., deserving data exclusivity)? What terminology and names/identifiers are needed for active agents and products for different uses and user communities, particularly in the context of biosimilars/follow-on biologics? How does one come up with useful names, including acceptable specific and (bio)generic names, for these products?; and should names be based on the scientific (entity-based), regulatory (approvals-based) and/or market (real world) aspects of each product? Who will develop and control product definitions, nomenclature, information resources, and how will this information be disseminated? Should these aspects be controlled by FDA or industry? These are difficult issues with broad ramifications.

Someone (or, ideally, multiple organizations representing diverse interests) needs to provide recommendations for terminology, definitions and active agent/product nomenclature (names) relevant to various user communities and track/identify marketed products, particularly in the context of biosimilars/follow-on biologics. But, essentially all organizations that should be involved, including trade, professional associations and governments, are avoiding these complex issues and/or have conflicts-of-interest; and with information needing to be freely disseminated, there is no incentive for the private sector to do the job. The U.S. BIOPHARMACOPEIA™ Registry of Biopharmaceutical Products is proposed as, ideally, an industry-based and -funded collaborative scientific/educational project to provide what is needed.

U.S. BIOPHARMACOPEIA™ Registry of Biopharmaceutical Products

new terminology, taxonomy, nomenclature and registry systems for biopharmaceutical products and active agents in commerce

designed from basic chemical/biomedical information principles to handle biopharmaceuticals, including biogenerics

provides candidate unique and (bio)generic BIOPHARMACOPEIA™ names for products and active agents for adoption
by regulatory agencies, formularies, reference sources, public use, etc.

industry-sponsored, including a free public Web site/database; Contact us for further information.

Proposal now online Join the mailing list (announcements only; not a discussion group)

Links are provided below to articles by the the Web master,

Ronald A. Rader, concerning biopharmaceutical information, including biopharmaceutical and biogeneric terminology, nomenclature systems and the infrastructure of information resources supporting the biopharmaceutical industry.

published in Nature Biotechnology, July 2008, 26(7), p. 743-751, by Ronald A. Rader, President, Biotechnology Information Institute

"Re(defining) Biopharmaceutical" [good for general background]

Abstract: This peer-reviewed article updates and synthesizes much of my prior two-part series, "What is a Biopharmaceutical?," and other articles (available below). This includes discussion of the various definitions of 'biopharmaceutical'; the complexities of these agents/products and what differentiates biopharmaceuticals from drugs (chemically-derived, chemical substance-based pharmaceuticals), including the process=product paradigm; the flaws and problems caused by the aberrant definitions in common use promoted by vested interests, including in the context of biogenerics/biosimilars/follow-on proteins; and proposes actions to resolve these problems, including the U.S. BIOPHARMACOPEIA Registry of Biopharmaceutical Products.

published in BioProcess International, March and May 2007, by Ronald A. Rader, President, Biotechnology Information Institute

"What Is a Generic Biopharmaceutical? Biogeneric? Follow-On Protein? Biosimilar? Follow-On Biologic?"

Part 1: Introduction and Basic Paradigms

Abstract: The concepts, paradigms, terminology and definitions concerning generic biopharmaceuticals (biogenerics) are still in a primitive state. Use of essentially all current terms may support, denigrate or obfuscate various views and discussions of the topic, e.g., to many 'biogeneric' evokes negative connotations from association with generic drugs and/or suggests that products are identical, rather than similar/related. There are three basic views/paradigms/definitions of generic biopharmaceuticals. Entity-based views concentrate on the products and active agents, including chemical structures and the unique aspects imparted by their biological source/identity, manufacturing process and specifications (process=product paradigm). Regulatory-based views concentrate on biopharmaceuticals as being approved or on track for approval as biogenerics (involving abbreviated filings based on comparative testing, sometimes therapeutic equivalence/substitution). Market/commercial-based views concentrate on products as competing for similar/same indications, having similar names, or any other perceived similarities. Depending on the view/paradigm/definition used and whether one takes a world or just Western (major market)-centric view, there are currently either many (hundreds), some or just a few biogeneric products in commerce; and biosimilars/follow-on biologics/biogenerics have either been around for a century or more, a few decades, a few years or do not yet even exist.

Part 2: Information, Nomenclature, Perceptions, and the Market

Abstract: Because of their complexity, biopharmaceutical products defy use of various conventional chemical and pharmaceutical information paradigms and methods that work well with drugs and other chemical substances. Before one can deal with biogenerics, difficult questions must be answered, e.g., What defines a biopharmaceutical agent or product as unique and distinct from others?; And, what entity-, regulatory-, and/or market-based changes in an agent or product require it to be considered a new, different one? Biopharmaceuticals will have to be defined, named, and tracked. But how should names be assigned, particularly to biogenerics? Should generic/similar names be assigned, facilitating marketing as generics but likely decreasing safety, or should unique names be assigned, favoring safety but likely decreasing the cost savings generic offer? Both unique and (bio)generic names for both finished products and active ingredients will be required for different uses/users. However, current nomenclature systems are inadequent for biopharamceuticals, e.g., with systematic nomenclature (IUPAC and CAS) designed to index the chemical literature, and nonproprietary pharmaceutical nomenclature (USAN and INN) designed to handle small molecule, particularly generic, drugs. New paradigms, terminology, taxonomy, and nomenclature systems are needed for biopharmaceuticals, particularly ones that include biogenerics. This industry maturation will be painful, requiring industry and regulators to define products, their relationships and develop related information resources and educational programs. The U.S. BIOPHARMACOPEIA Registry of Biopharamceuticals will assist in this process by developing new nomenclature systems, candidate names and a public Registry of biopharmaceutical products.

"What is a Biopharmaceutical?" - published in the March and May 2005 issues of BioExecutive, by

Ronald A. Rader, President, Biotechnology Information Institute:

Part 1: (Bio)Technology-Based Definitions - This reviews the four very different basic views/paradigms/definitions of what is a biopharmaceutical, concentrating on technology-based definitions, and the terms and definitions used by U.S. and European Union regulatory authorities.
Part 2: Company and Industry Definitions - This reviews and critiques the views/paradigms/definitions of 'biopharmaceutical' no longer linked to biotechnology, with these aberrant definitions often adopted by many in the financial community, press, companies and even major U.S. trade associations (BIO and PhRMA).
Abstract - Pharmaceuticals are composed of two major subsets - biopharmaceuticals and drugs (the vast majority). Biopharmaceuticals are pharmaceuticals inherently, usually obviously, biological in nature (e.g., proteins, cells) manufactured using biotechnology (involving live organisms). A derivative view limits this to recombinant proteins. Two other common views/paradigms/definitions ignore linkage to biological nature/biotechnology and take business/market-centric views. These either include as being biopharmaceuticals any/all pharmaceuticals connected with a biotechnology-like (small, entrepreneurial) company or that otherwise can be portrayed as being high-tech; or simply consider all pharmaceuticals to now be biopharmaceuticals (i.e., the drug/pharmaceutical industry is now the biopharmaceutical industry). These later two views are very common, but are dysfunctional, e.g., they arbitrarily include many or even all small molecule and other drugs (pharmaceuticals inherently chemical, not biological, in nature and manufactured by chemical means). With the biopharmaceutical industry lacking its own trade organization representing its interests [and sponsoring projects such as the BIOPHARMACOPIEA], the widespread misuse, cooptation and obfuscation of 'biopharmaceutical' (and 'biotechnology') places the underlying definitions, identity and public perception of the industry at risk to public relations, lobbying and rebranding efforts; and confounds discussions of biopharmaceuticals and related issues, e.g., biogenerics.

"Nomenclature and Registry Systems for Biopharmaceuticals and Biogenerics":

[The links below provide access to sections of a large draft article, much of which is discussed more briefly in the ""What Is a Generic Biopharmaceutical?..." articles above].

Abstract: There are no simple ways to define and assign useful nomenclature (names and other identifiers) to specific biopharmaceutical products, including biogenerics, which add further levels of complexity. This includes names that are unique, unambiguous and useable (relatively short, pronounceable, etc), and generic names that convey information regarding entity, activity, therapeutic equivalence/substitution, class or other relationships among products. Nomenclature systems that work well for chemical substances and drugs fail when applied to biopharmaceuticals and biogenerics. This article discusses problems with conventional drug/chemical nomenclature and registry systems as applied to biopharmaceuticals, and the controversies likely to be associated with selection of official names, both unique and generic, for biopharmaceuticals, particularly biogenerics. Nomenclature, since it greatly affects marketing, particularly the names to be officially adopted (for filling of prescriptions) for biogenerics, will be a very contentious issue.

Nomenclature in Biopharmaceutical Products in the U.S. and European Markets (the book/database by this author)

Products/Active Agents Index: view 3,700 entries from the book's nomenclature index

"The Status of the Infrastructure of Information Resources Supporting the U.S. Biopharmaceutical Industry -- Shades of Grey and Black"

Abstract - Serious deficiencies persist in the infrastructure of information resources supporting the U.S. biopharmaceutical industry. Basically, no one has ever paid any attention to the many information problems in the area of biopharmaceuticals, e.g., with biopharmaceuticals lacking functional nomenclature and taxonomy systems (see above), and little or no truly authoritative product information available. A seemingly infinite number and variety of information resources provide access to basic scientific and medical/use information. However (other than Biopharmaceuticals in the U.S. and European Markets, by this author), there are hardly any useful information resources for the most basic information about marketed biopharmaceutical products, e.g., what they are, how they are made, approvals, companies involved, patents, markets/sales, etc. Most available information originates from "grey" or "fugitive" sources that are usually ephemeral, unpublished, unsigned and undated (e.g., regulatory documents, Web sites, information from companies, etc.) or bits and pieces extracted from diverse published sources (industry newsletters, patents, etc.), with the user/analyst left to make judgments about the quality and relevance of information to the products of interest. Better access to basic product and other information is essential to industry maturation and public acceptance.

Contact/Further Information:

Ronald A. Rader
President
Biotechnology Information Institute
1700 Rockville Pike, Suite 400
Rockville, MD 20852
E-Mail: ron@biopharmacopeia.com
Phone: 301-424-0255 (9AM-5PM, Eastern U.S.)
[Phone is the most reliable method].

*This material is solely authored by Ronald A. Rader, President, Biotechnology Information Institute. This material presumes the reader is already at least familiar with the topics discussed. Your comments are most welcome.