The Top 5 Biosimilars Articles for the Week of June 8

Hi, I’m Skylar Jeremias 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 June 8, 2020.

5. Downward “drift” in batches of reference trastuzumab shed more light on the importance of antibody-dependent cell-mediated cytotoxicity on survival, investigators reported at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.

4. The COVID-19 pandemic put a crimp in the FDA’s new drug and biosimilars review activities. In so doing, the pandemic helped make the case for an FDA project to upgrade its system for assessing its resource needs for biosimilar application reviews.

3. Mylan and Lupin announced that the European Commission has approved their etanercept biosimilar, Nepexto, for all indications of the reference product.

2. A recent settlement over patent challenges will enable Amgen to bring its biosimilar for eculizumab to market in 2025, giving originator company Alexion breathing space to bolster its revenue base by developing sales of a follow-on product.

1. As part of pilot program designed to improve access to cheaper medications in oncology, a rituximab biosimilar from Celltrion has been approved for use by the World Health Organization (WHO).

To read all of these articles and more, visit centerforbiosimilars.com.