News

The FDA’s new focus on coronavirus disease 2019 (COVID-19) and the quarantines imposed on much of the developed world have pushed digital and remote marketing of pharmaceutical products into high gear, according to Jamie Peck, managing director of iON.
NeuClone said phase 1 patient monitoring and blood sampling has been completed for its ustekinumab biosimilar candidate, which is targeted at the $6.6 billion in annual revenue earned by Stelara, a Janssen Pharmaceutical Companies product.
 
Longtime generics manufacturer Lannett is moving an insulin glargine biosimilar development plan forward and announced an upcoming meeting with the FDA. The agent would compete with the reference product Lantus.
Because they will see greater savings, employers have greater incentive to embrace biosimilars than plan sponsors in the overall insured population. Employers can be advocates for policy changes that promote biosimilars by contacting legislators; they can organize email campaigns to reach lawmakers more easily.
 
There are multiple distinctions in labeling indications between biosimilars and brand products, and pharmacists must become familiar with these to be of maximum service to patients and physicians, according to a review.
The National Comprehensive Cancer Network (NCCN) Guidelines may help get biosimilars into circulation because the NCCN will recommend them for off-label uses.
 
In inflammatory bowel diseases (IBD), biosimilars have been available for roughly 5 years, but more evidence may be necessary to persuade medical community to increase usage, according to a study.
 
Trade groups and consumer advocates are working to fight the rising tide of protectionism generated by the coronavirus disease 2019 pandemic. The International Generic and Biosimilar Medicines Association (IGBA) is calling for dedicated air and sea channels to keep pipelines of essential medicines open between borders.
 
What is ahead for biosimilar litigation? We highlight a recent interview Goodwin partners gave recently about their new guide to biosimilar litigation. 
The Center for Biosimilars® recaps the top stories for the week of March 30, 2020.

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