The Top 5 Biosimilars Articles for the Week of October 9

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of October 9.


Hi, I’m Kelly Davio 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 9.

Number 5: A growing number of physicians and patient groups are voicing concern over step therapy, or “fail first” policies, which can make it more difficult for patients to receive biologic and biosimilar therapies.

Number 4: A recent study provided much-needed data on the use of biosimilar infliximab in children with inflammatory bowel disease.

Number 3: Contributors George Yu and Christopher Bruno of Schiff Hardin discuss the recent decision in the case of Amgen v Hospira and its implications for safe harbor in biosimilar development.

Number 2: Contributor Sonia T. Oskouei addresses the question of what the United States can learn from the European experience with biosimilars.

Finally, Number 1: The FDA has issued Mylan and Biocon a Complete Response Letter for their proposed pegfilgrastim biosimilar, referenced on Neulasta.

To read all of these articles and more, visit