The Drive for Best Practice in Biopharmaceutical Manufacturing - Key business considerations when developing biosimilar products virtually. - BioPharm International

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The Drive for Best Practice in Biopharmaceutical Manufacturing
Key business considerations when developing biosimilar products virtually.


BioPharm International
Volume 25, Issue 3, pp. 60-64

Headquartered in Burgdorf, Switzerland, Finox Biotech was founded in late 2007, but interestingly not by pharmaceutical development professionals. Nevertheless, the company has made considerable progress in developing its first biosimilar. Afolia, a recombinant-human follicle-stimulating hormone, was taken on the journey from cell bank to the end of Phase III clinical trials within just four years. In this article, the cofounder and CEO of Finox Biotech, Anjan Selz, shares insight into the company's approach to biosimilar development.

TARGET SELECTION

Biosimilars are a hot item in the pharmaceutical industry; many companies, no matter the size or focus, are venturing into the space. Some people give the impression that filling a pipeline with any compound is more important than having a carefully chosen selection of targets to fit an overall strategy. How else could one explain the fact that there are still new erythropoieitin (EPO) biosimilars being developed for the European market despite the fact that the first such biosimilar was approved by EMA in 2006?

For a small start-up company, such as Finox Biotech, careful target selection is crucial because it often decides the fate of the company; the first compound will either be the sound foundation on which to build further product offerings or bring the company to its knees.

In fact, Finox Biotech was offered an EPO for consideration shortly after its establishment, but the company turned down the opportunity for two reasons. First, the timing was bad; in late 2007 there were already several EPO biosimilars on the European market or about to enter it. Second, Finox Biotech had a keen awareness of with whom we would be competing. EPO is a blockbuster and therefore attractive to large established companies; as a small start-up it would have been difficult to compete. Therefore, the company chose to focus on opportunities in markets that were still worth the heavy investment required for biosimilar development, but at the same time used compounds that were below the radar of most large companies.

Today, it seems that almost everybody wants to move into monoclonal antibody (mAb) biosimilars, which is understandable given the high originator turnovers in the respective therapy fields being threatened by the loss of patent protection. But where there is high turnover, there is strong competition. Perhaps more important, the development complexities involved in such large biologics poses a huge challenge. Whereas the full characterization and comparability exercises required for a small biologic such as r-FSH seem feasible to a start-up company, it can be quite difficult to take on mAbs considering their inherent complexity and the reliability risks associated with their huge clinical-trials.

Yet, more important criteria for target selection are the intellectual property (IP) and regulatory landscapes for a given compound. If regulatory expectations for a given target or class of targets are not clear, it can be too risky to invest millions in product development. If by chance, one manages to match authority expectations, it would be even more frustrating to fall from such heights when market success is not decided on the prescribing physician's desk but on that of a patent lawyer because of a fuzzy IP landscape.

Last but not least, a crucial criterion for target selection is the opportunity for product differentiation. Industry discussions on biosimilar differentiation far too often center on price alone. However, in many therapeutic fields—especially in prescription drug products and in the absence of automatic product substitution mechanisms—the prescription decision is more complex and based on factors other than price. Biosimilars, for example, may not be big sellers when only if they are given a markdown of just 20–30% compared with the originator product. The biosimilars industry can hurt itself heavily in the long-term with price-focused competition. Having invested substantial sums for development, registration and marketing of a biosimilar, a negative spiral of continuous markdowns with subsequent and incessant eroding margins is definitely not the investor's first choice.


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