Me-Too's Struggle
Contrary to common belief, the development of follow-on drugs, often referred to as me-too drugs, does not begin after a first new drug in a therapeutic category receives market approval. The reality is that sponsors are engaged in drug development races that are intensely competitive where the first drug candidate to receive marketing approval belongs to the sponsor that got to the finish line with a satisfactory submission the fastest.
Contrary to common belief, the development of follow-on drugs, often referred to as me-too drugs, does not begin after a first new drug in a therapeutic category receives market approval. The reality is that sponsors are engaged in drug development races that are intensely competitive where the first drug candidate to receive marketing approval belongs to the sponsor that got to the finish line with a satisfactory submission the fastest.
Follow-on Drug Competition Intensifying
A new study by Tufts CSDD shows that market exclusivity periods for first-in-class drugs have fallen dramatically from nine years on average in the 1960s, to 2.3 years in the 2000s. Moreover, competition between follow-on drugs has heated up as the average time between first and second follow-on drugs has been compressed from an average of 13.5 years in the 1960s to slightly more than one year on average in the 2000s. As each new drug enters a therapeutic category, other drugs in that category typically lose market share. As such, intense competition threatens to erode and dampen sponsors' return on development investment.—Tufts Center for Drug Development, http://csdd.tufts.edu
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
Study Finds Many Randomized Clinical Trials Have Poorly Justified Exclusion Criteria
January 21st 2025Investigators find that most exclusion criteria in critical care randomized clinical trials are justifiable, but 60% include at least one poorly justified exclusion, most commonly affecting pregnant or lactating individuals.
STEP UP Trial Shows Semaglutide 7.2 mg Achieves Superior Weight Loss vs. 2.4 mg, Placebo
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