From the Editor June 2015

S. Anne Montgomery

June 16, 2015

3 Min Read

FtE-SAM-263x300.jpgMore often than we realize, industry literature suffers from discrepancies in definitions of (seemingly) common, basic terms. We have pointed this out before — twice addressing the differences between analytical and bioanalytical testing, for example, and cautioning against misunderstanding the distinctions. Some terms are interchangeable, though, or it may be too soon to separate them from one another (e.g., cell therapies and therapeutic vaccines).

We editors accept much of this as normal. Differences in interpretation will persist, and often a general point can be made without delving into their minutiae. But determinations of the fledgling biotech industry 25 years ago may need occasional dusting off and revisiting. Distinctions understood by the first wave of modern bioprocessors may be accepted by those new to the industry without the critical lower-iceberg foundation of historical knowledge. As biotechnology enjoys greater public awareness — and as patients, providers, and investors rely on the Internet more frequently for research — resulting confusion may negatively affect healthcare decisions, reimbursement issues, and investment directions.

For this issue’s special report, we asked the writer to look at how companies decide between biosimilar and biobetter development programs. We were interested in delving into what influences such decisions, whether driven by a need to protect or expand a company’s own product portfolio and patent position or the influence of regulatory pathways offered across the world. And we suspected that much was happening behind the scenes to influence such decisions.

Our first surprise: We encountered differences in how biobetters are defined. Can you “better” only drugs that your company already owns? Must you work with the same active molecule, or can you develop another like it for the same indication but in, say, a different formulation? From a certain (regulatory) perspective, what we call “biobetters” are simply new drugs. But the “well-characterized” paradigm allows you to make certain changes to your own product — and others may seek to market their new drugs as a “better” alternative to yours. Along with the frequently posited question of “How similar is similar?” perhaps we also should ask, “How different is different?”

With pressure to reduce healthcare costs, an important remit of the biopharmaceutical industry is to clearly communicate what its products are (and are not). We are not always singing to our own choir, so to speak. The Internet popularizes this field, and we have no idea what information will be picked up as citable fact (and by whom). In the special report, you will see a note from our senior technical editor, Cheryl Scott, correcting the New York Times’ identification of two drugs as biologics that are actually synthetic small molecules. So how many biosimilars are approved in the world? Well, how do you first define biopharmaceutical? And are your survey responders defining terms the same way you are? Published numbers don’t always agree with one another, and differences in definition (positioning) are much to blame.

As different product classes emerge and will themselves become subject to biosimilar competition someday — especially when some are combinations of small- and large-molecule components — smart readers and writers need to remember to pay attention to the definitions on which their analyses rest. It all comes down to a basic rule that I used to tell college freshmen in introductory writing classes: Begin by defining your terms.SAMfix-sig-300x73.jpg

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