The Center for Biosimilars® recaps the top news for the week of October 1, 2018.
Hi, I’m Samantha DiGrande for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilars articles for the week of October 1.
Number 5: The FDA announced this week a revised draft guidance that it says will help ensure that citizen petitions cannot be used by brand-name drug makers to delay the market entry of generics or biosimilars of branded products.
Number 4: A recent study randomized and dosed 589 patients with breast cancer with either Apotex’s pegfilgrastim biosimilar, the European Union-licensed reference pegfilgrastim, or the United States-licensed reference pegfilgrastim, and found that the biosimilar demonstrated similarity to both reference products.
Number 3: The FDA has released a draft guidance document relating to potential fines that may be incurred if submitters of data and trial information on clincialtrials.gov either do not report clinical trial results, or misreport findings.
Number 2: The Association for Accessible Medicines and the Biosimilars Council, a division of AAM, have submitted comments to the FDA in reference to its Biosimilar Action Plan.
Number 1: Pfizer has indicated that its filgrastim biosimilar, Nivestym, will be priced at a wholesale acquisition cost of 350 dollars and 40 cents per 480 microgram pre-filled syringe, which accounts for a 30.3% discount to that of the reference product, Neupogen.
Finally, last week, our e-newsletter asked whether direct-to-consumer advertising should include drugs’ list prices.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.