Daniel Galbraith, Ph.D.

The approaching biosimilars tidal wave puts the question of animal testing for biologics further under scrutiny.

Over the past twenty years, attitudes toward animal testing in both the U.K. and U.S. have shifted noticeably. This is supported both by polling data as well as everyday observation. For example, a quick swing through a drug store circa 1994 in either country would not likely have uncovered a “not tested on animals” label. Now such are ubiquitous on cosmetics and many other products sold in the U.K., and are becoming more and more common in the U.S.

The basic pattern is that public sentiment shifts, and regulations shift accordingly. This has not yet fully come to pass, though, in the field of biopharmaceutical manufacturing. Some of us in the industry are left wondering, then, when the other shoe will drop.

An opinion piece by R.L. Sheets of the NIH published last year in Vaccines brought this issue to the forefront, at least for this chief scientific officer. The piece “Opinion on adventitious agents testing for vaccines: why do we worry so much about adventitious agents in vaccines?” takes a close look at testing for foreign substances in vaccines. The piece ultimately concludes that animal testing is unnecessary in such instances, calling for “a more scientific and rational means” of addressing concerns about the quality and safety of vaccines.

Such issues are of considerable interest to us. If animal testing in vaccines or other products is shown conclusively to be unnecessary, then we would welcome the chance to cease the practice and would encourage others to do so as well. Best practice would suggest that we seek to run our tests in ways that are more efficacious, less expensive, and that use fewer animals.

Unfortunately, and paradoxically, even as public opinion continues to harden against animal testing, the pharmaceutical industry is actually using more animals in the testing of biologics, and biosimilars are no exception.

The biosimilars tidal wave is starting to take form; Novartis CEO Joe Jiminez recently referred to it as a “looming biosimilars boom.” Last year’s biosimilars sales of $1.3 billion are predicted to skyrocket to $35 billion by 2020—all the more reason, then, that the testing industry really can no longer afford to ignore this issue.

In the U.K., life sciences companies are being strongly encouraged to find ways to reduce the number of animals used in research via the 3Rs initiative (Reduce, Refine, Replace). The U.S. has its own share of voices similarly calling for reductions. Aside from such government and public opinion pressures, though, it is also in the industry’s interest to confront this issue for companies’ bottom line: Animal testing is very expensive.

While biosimilars may wind up reflecting something similar to the 30% average discount of generic pharmaceuticals, the costs of in vivo testing at these levels can noticeably cut into profit margins.

Those of us in industry on both sides of the pond need to come together to create a new set of guidelines, putting each and every testing category into sharp focus and asking, “Is this test necessary? Are there ways of reducing animal testing here without compromising product quality or safety standards?”

We also need to take a collective look at the road ahead. If we continue in our present trajectory, the numbers of animals used in testing product will continue to increase.  We need to look at the other side of the question, “What if?” We need to ask ourselves where we will go if we move away from animal testing. Our industry must be prepared to confront these issues. Such a discussion will inevitably lead to change. Change is coming, though, regardless of whether we impose it on ourselves or not.

If such an industry discussion doesn’t take place and we continue to wait, it seems inevitable that the heavy hand of government will do so for us, and we may not be pleased with the outcome.










































Daniel Galbraith, Ph.D. (dgalbraith@biooutsource.com), is chief scientific officer and founder of BioOutsource, a contract research company based in Glasgow, Scotland with offices in Cambridge, MA. For more color on this topic, please see a full statement Dr. Galbraith helped craft here. The views expressed in this paper are the personal views of the author. 

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