The Top 5 Biosimilars Articles for the Week of October 1

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Number 5: The FDA announced this week a revised draft guidance that it says will help ensure that citizen petitions cannot be used by brand-name drug makers to delay the market entry of generics or biosimilars of branded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Number 3: The FDA has released a draft guidance document relating to potential fines that may be incurred if submitters of data and trial information on either do not report clinical trial results, or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