Five things for pharma marketers to know: Friday, March 6
The FDA approved the first biosimilar, a move that will introduce a potentially cheaper alternative to Amgen's blood biologic Neupogen. Like Neupogen, the newly approved Zarxio, which is manufactured by Novartis, can be used to treat the same indications, including certain cancers. The FDA still has to clarify what it will call biosimilars. Generic versions of brand-name drugs are given the same name based on the active ingredient, which helps physicians and pharmacies identify them. For now, the FDA named Zarxio filgrastim-sndz. The active ingredient in Neupogen is filgrastim. Marketing for the drug will likely focus on educating physicians about biosimilars as well as the cost advantages of using Zarxio instead of Neupogen.
A federal judge ruled that four members of the FDA's tobacco advisory panel had conflicts of interest, which prompted their departure from the panel. After the judge's ruling last year, members of the panel were rescreened, the Associated Press reported. FDA panels make recommendations to the FDA. Although the agency doesn't have to follow those recommendations, it usually does.
Sequenom Laboratories disclosed that its noninvasive prenatal genetic tests have discovered cancers in at least 26 pregnant women. Tests such as Sequenom's MaterniT21 Plus are largely unregulated by the FDA, and the discovery of unexpected cancers has raised questions about how the companies should handle the results, BuzzFeed News reported. There are at least five other companies that sell similar tests and demand for the tests is on the rise.
GE Ventures and Stanford Health Care created Evidation Health, which will evaluate the effectiveness of digital health technologies, according to MobiHealthNews. The findings will help other healthcare companies, including start-ups and drugmakers, better understand the clinical and economic evidence for new technologies.
An FDA official told the Wall Street Journal's Pharmalot blog that Orexigen Therapeutics may face civil monetary penalties, seizure or injunction for disclosing clinical trial data in a Securities and Exchange Commission filing. “The FDA also has the option to initiate the withdrawal of an approved new drug application,” Dr. John Jenkins, director of the FDA's Office of New Drugs, told the blog.