Abstract: The concepts, paradigms, terminology and definitions concerning generic biopharmaceuticals (biogenerics) are still in a primitive state, and anarchy and chaos prevail. Use of essentially all current terms may support, denigrate or obfuscate various views and discussions of the topic, e.g., to many 'generic' (and 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 biogenerics have either been around for a century or more, a few decades, a few years or do not yet even exist.
No comments:
Post a Comment