Competitive Pressure for First-in-Class Drugs is Intensifying
Applied Clinical Trials
Study shows sharp reduction in market exclusivity periods for first-in-class treatment entrants.
Competition between drugs within a given class has intensified, according to a new study recently published by the Tufts Center for the Study of Drug Development (Tufts CSDD). Newly approved first-in-class prescription drugs face substantially shorter periods of exclusivity within which to recoup the high and rising cost of drug development.
Tufts CSDD reviewed 40 multiple-entrant pharmacologic classes that produced 108 new drug approvals in which the first-in-class agent received approval between 1998 and 2011. Comparing market exclusivity periods for drugs approved between 1998-2004 and those approved between 2005-2011, the results show a 51% reduction in the median time-from 4.7 years down to 2.3 years-from when the first-in-class drug was approved to when the first competitor entered the market. Three-out-of-four second entrants in a given drug class were approved within 3.7 years and 25% were approved in less than six months. Tufts CSDD also found that nearly half (49%) of the 40 classes examined eventually had three or more competitors.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
