"Biosimilar Strategy & 351K", by D. A. Prasanna, at 'CPhI 2014, Paris 2014

Biosimilar development is a landmine of complexities with respect to regulatory, manufacturing, and marketing aspects, making it one of the most expensive development propositions in the pharmaceutical industry and related clinical research organization services. Like generic pharmaceuticals, biosimilars enter the market with the aim of reducing healthcare cost, but entry to the biosimilar market carries higher costs, greater risks, and more time and expertise in relation to the clinical development of these products.

Furthermore, the marketing and launch of biosimilars requires a different strategy than small-molecule generics. The considerable costs to obtain FDA approval, and the substantial costs to develop manufacturing capacity, will limit the number of biosimilar competitors. In this scenario, very few biosimilar manufacturers are likely to ttempt entry for a given innovator product and are unlikely to introduce their drugs only at discounts normally in the range of 10% to 30% of the innovator product price. Further, the lack of automatic substitution between a biosimilar and an innovator product will slow the rate at which a biosimilar can obtain market share. Therefore, it is easy to see that currently, the type and amount of resources required for biosimilar development can create high barriers of entry, not just for small to mid-sized companies, but even for the larger, well-established generics players and global biopharmaceutical companies. Gaining market share for a biosimilar could be challenging when there is no added benefit over the innovator and insignificant cost savings. The price decrease can be achieved when multiple biosimilars are introduced to the market. On the other hand, if a substantial price decrease is not viable for a biosimilar, a better strategy seems to be to develop a biosimilar as a new product. It would benefit the sponsor to use a scientific rationale and its own non clinical and clinical testing, most of which will be required anyway, to develop its product as a unique innovator product, and gain the benefit of extended market exclusivity.
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