Determination of the Optimal Strategy for a non-US Drug to Enter the US Market
Client Challenge: An ex-US biotechnology firm with a novel approved drug needed to ascertain the optimal method of entering the US market in terms of both indications to be pursued and prescription or OTC status.
Our Approach: BioAsset employed a dual-pronged methodology to address our client’s needs. We profiled the US market for current comparable drugs in both the Rx and OTC markets to establish comparables and determine the overall potential size of the market. We also conducted extensive primary market research with a broad cross section of physicians to understand their propensity to prescribe/recommend the drug as either an Rx or OTC and also understand the level of clinical evidence required for acceptance.
Results: Based on our work, a strong recommendation was made that the drug be used in both pediatric and adult indications as a prescription drug, which … Read More »