A Semi-Continuous Operations Model For Generic Solid-Dose Manufacturing
The estimated timeline for a drug product from discovery to market is 10 to 15 years. However, less than 12 percent of drug candidates that enter clinical trials will ultimately receive FDA approval. The Orphan Drugs Act of 1983 ensured that there were adequate incentives offered to drug developers working on therapies to treat fewer than 200,000 patients in U.S. The initiative was very effective in correcting a segment that was largely neglected by research-based pharmaceutical corporations – today, there are more than 450 orphan drugs on the U.S. market. Orphan drugs were approximately 50 percent of the approved drug products based on FDA approval tracking. As a result, the new small molecule generic pipeline will potentially comprise fewer high volume products.
This article will explore the evolving generic drug environment in the U.S. It will also describe an operations model for semi-continuous manufacturing of generic solid-dose products that will improve flexibility and enable just-in-time production.
The Current Generic Manufacturing Landscape
In August 2017, the FDA reauthorized the Generic Drug User Fee Amendments (GDUFA) to ensure patients have access to affordable and safe generic drugs. The FDA’s new commissioner, Scott Gottlieb, M.D., has devised strategies to minimize barriers to generic drug competition and bring down drug prices, and the impact has already been felt within the industry. As a result of GDUFA-related initiatives, the number of abbreviated new drug approvals (ANDAs) granted in 2017 is projected to be close to 756, almost 100 more than in 2016. The increased number of approved generic drug products and manufacturers in the market is expected to shift the demand curve and induce cost moderation. Accessibility of multiple generic sources will also drive down the volume blocks for competing drug manufacturers.
The recent acceleration in generic price erosion is partly due to a product approval surge for some smaller generic manufacturers. Many generic manufacturers maintain a diverse product portfolio to maintain a competitive edge in the market, as generic products make up the majority of the prescription market share (91 percent filled). FDA’s new risk-based policy and inspection concept of operations (ConOps) will have an impact on such generic pharmaceutical firms, as complex portfolios increase regulatory risks.
