Generic And Branded Thyroid Drugs "Equal"

22 April 1997

Patients being treated for hypothyroidism obtain similar therapeuticoutcomes whether they receive branded thyroid drugs or their generic counterparts, according to a report in The Journal of the American Medical Association (April 16 issue). This study has been suppressed for seven years and has only been published after Knoll Pharmaceutical, the manufacturer of Synthroid (levothyroxine), which dominates the $600 million market in the USA, agreed not to sue the study's authors, Betty Dong et al of the University of California Medical Center, reports the Wall Street Journal.

The study concluded that two brand-name levothyroxine products, Synthroid and Levoxyl (a cheaper brand name product similar in price to generic forms), are bioequivalent to two generic levothyroxine products and "are interchangeable without loss of therapeutic efficacy in the majority of patients for treatment of hypothyroidism." The authors estimated that if generic drugs or Levoxyl were prescribed instead of Synthroid, annual savings in the USA could amount to $356 million.

Drummond Rennie, deputy editor of the JAMA, explains that "in 1987, to establish that Synthroid was truly more effective than competing preparations, Flint Laboratories, then manufacturer of Synthroid, approached Betty Dong at UCSF....Flint and Dong signed a lengthy protocol/contract to finance comparative studies of the bioequivalence of Synthroid and three other preparations, and both sides expected the study to show that Synthroid was superior."

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK





Today's issue

Company Spotlight