1. Develop well-grounded biopharmaceutical product information paradigms, terminology, taxonomies and nomenclature -- an integrated functional framework for how to think of, characterize/define, differentiate, classify/group and name biopharmaceuticals.
2. Develop methods to understand and express the unique and generic (similar) aspects of biopharmaceuticals in terms of information; and
3. Provide an authoritative public resource (Registry) for biopharmaceutical terminology, nomenclature and product identification.

Secondary goals include providing coherent, integrated and, thus, compelling working paradigms, terminology and nomenclature for biopharmaceuticals and, particularly, biogenerics useful for a) framing public discussions/debates and b) adoption/adaptation for the regulation of biopharmaceuticals and, particularly, biogenerics.  No one else is working in this area, e.g., the biopharmaceutical industry lacks a trade association dedicated to its interests.  The BIOPHARMACOPEIA Registry will likely be in place before FDA and EMEA/EU ever get around to implementing regulations for all but the simplest biopharmaceuticals and, perhaps, before Congress passes new laws for generic biologics.  Without guidance, regulatory agencies and legislators will surely make a mess of things and/or follow their usual pattern of ignoring ever defining underlying concepts, terminology (e.g., EU regulations never actually define "biosimilar") and nomenclature systems.  Substantive discussions/debates of regulations for follow-on proteins and generic biologics will need to take into consideration and respond to the BIOPHARMACOPEIA Registry. 

What needs will this fulfill?

As discussed in various articles by this author, including those accessible at the www.biopharmacopeia.com, chaos and anarchy prevail in the basic ways we think of and refer to biopharmaceutical products. There has been little thought, public discussion and certainly no consensus on how to define biopharmaceutical products and characterize their unique and generic (similar) aspects.  New information-based paradigms, taxonomies, terminology, nomenclature and registries are needed to provide a solid basis for understanding, discussing and dealing with biopharmaceuticals, particularly, with the advent of generic biopharmaceuticals.  FDA, other regulatory agencies and those organizations currently providing chemical and drug nomenclature appear unlikely and ill-suited to accomplish this without assistance.

What will the Registry project do?

What is wrong with current nomenclature and registry systems? Why are new ones needed?

For further information, see Nomenclature and Registry Systems for Biopharmaceuticals and Biogenerics. Simply stated, current pharmaceutical and chemical nomenclature and registry systems have been tailored to drugs and other chemical substances, not biopharmaceuticals.  Current nomenclature systems as applied to biopharmaceuticals provide names/identifiers that are neither sufficiently unique, i.e., describe/differentiate distinct products, nor generic, i.e., classify/characterize similarities among products.  Conventional systems fail to take into account the complexity and unique aspects of biopharmaceuticals associated with their biological nature and manufacturing processes (i.e., the process=product paradigm); fail to recognize these as distinct highly-regulated commercial products (i.e., generally ignore commercial and regulatory aspects that define distinct products in the real world); and fail to recognize the diverse aspects that confer similarities among biopharmaceuticals.  What works well and was designed for naming chemicals in the scientific literature (IUPAC and CAS) and for naming drugs (INN and USAN), including generic drugs, is inadequate for biopharmaceuticals, particularly in the context of biogenerics. These systems should not be compromised simply to accomodate biopharmaceuticals; and their parent organizations are too bureaucratic, slow and lack expertise regarding biopharmaceuticals.

What is wrong with systematic chemical nomenclature, e.g., CAS and IUPAC, and associated identifiers, e.g., CAS Registry Numbers?
These concentrate on the primary structure (e.g., protein sequences) of active agents, not products, and where this is not available, arbitrarily use trivial names as a basis for their nomenclature. This results in generic descriptors for active agents when applied to biopharmaceuticals, i.e., these names do not uniquely and unambiguously identify either specific commercial biopharmaceutical products or their active agents.
What is wrong with proprietary names, e.g., trademarks?
Trademarks and other proprietary names are inadequate and present problems in their use. Trademarks often apply to multiple and different products at different times, marketed by different companies, for different indications, in different countries, etc. Also, trademarks are private property, legally (although, generally ignored) can only be used as adjectives, not nouns (names), and their use would be too much like advertising.
What about nonproprietary nomenclature, e.g., INN and USAN, which has seemingly worked well for generic and other drugs?
These nonproprietary names, by their very nature/design, are generic names for active agents (not products); like systematic nomenclature, concentrate primarily on too few characteristics, e.g,. primary structure and/or activity classification; and ignore the biological/bioprocessing, regulatory and commercial aspects of products. These systems have been fine tuned for decades to the needs of (generic) drugs. USAN and INN have yet to be (nor should they be) adapted to adequately cover biopharmaceuticals, including biogenerics. And, INNs/USANsa are not currently even provided for major classes of biopharmaceuticals! New nonproprietary (bio)generic nomenclature systems are required to express the diverse relationships and similarities among biopharmaceuticals, particularly biogenerics (although, the Registry may selectively adapt or adopt USAN, INN or systematic names). Also, associated organizations, including USP and WHO, are too well integrated with generic drug regulation; their name selection processes are too slow and bureaucratic; and lack expertise with biopharmaceuticals. These systems and organizations are best left alone to continue to handle drug nomenclature.
What else is wrong with conventional chemical and drug nomenclature and registry systems?
These systems are too one-dimension and noninformative to appropriately handle biopharmaceuticals. These systems provide their names (and identifiers, e.g., CAS Registry Numbers) without ever fully defining/identifying unique commercial products or active agents (i.e., they give a name and that's all). At best, these systems list their names along with others, and fail to annotate the scope and limitations of their own and other names. This may work well enough for drugs, including generic drugs with their chemical substance active agents presumed to be the same, but these presumptions of sameness simply do not work for biopharmaceuticals and biogenerics.
What about FDA and other regulatory agencies as sources for product definitions, nomenclature, etc.?
FDA and other regulatory agencies have no mandate/funding and actually work hard to avoid being sources for information about the products they regulate. Approvals, by their very nature, are secret pacts between manufacturers and regulators regarding the standards/specifications for the processes and product at each stage of manufacture. FDA approvals often only confound the situation, e.g., approvals of biopharmaceuticals as biologics and drugs are inconsistent, and major changes in products/active agents, which most would agree result in a new distinct product, inconsistently result in original or supplemental approvals (which are not disclosed). Regulatory agencies consistently evade and ignore basic terminology and nomenclature issues concerning biopharmaceuticals. For example, FDA has still not released guidelines for even the simplest biogenerics regulated as drugs, avoids discussions of generic biologics, and EMEA/EU regulations never even define "biosimilar." Internally, FDA assigns nonproprietary "proper names" to biologics, but these are generic, not unique, and are used inconsistently. As discussed in a related article, FDA approval-related documentation often fails to even clearly identify the products approved, much less provide even a cursory description of what they are, their manufacture, CMC aspects, etc. FDA is best left to decide official names for pharmaceuticals in commerce, not develop nomenclature systems or candidate names.
What about appending a company name to a systematic or nonproprietary name to uniquely identify biopharmaceuticals?
Much like trademarks, company names change frequently, and it is often unclear which name to use (e.g., use the licensed manufacturer or the marketing company; what happens when multiple companies co-market the 'same' product or for different indications?); company names change frequently; and company names are often too long (e.g., Sanofi Pasteur; GlaxoSmithKline) to append to an often already long product/agent name. Using company names would require an independent company and, likely, short adopted company name registry system. Like trademarks, use of company names would look too much like advertising, and companies might try to game the system to make their names prominent.

Sponsor receive good will and visibility, including prominent acknowledgement, logos, etc. at the Registry Web site; and the opportunity to influence how we think of, define and name biopharmaceuticals and biogenerics. The primary sponsor may also have the opportunity to brand the public Registry, along the lines of the Merck Index, e.g., the 'Your Company' BIOPHARMACOPEIA™ Registry of Biopharmaceutical Products.

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

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