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
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.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.
