The Top 5 Biosimilars Articles for the Week of October 30

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Hi, I’m Laura Joszt 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 30.

Number 5: The FDA has announced that it will recognize 8 European regulatory agencies as capable of conducting manufacturing facilities inspections that will meet FDA requirements.

Number 4: More than 90% of Americans believe that the cost burden of cancer is too high, according to a nationally representative survey conducted on behalf of the American Society of Clinical Oncology.

Number 3: A New York union has filed an antitrust lawsuit against Johnson & Johnson, alleging that the maker of the reference infliximab has engaged in anti-competitive practices to keep biosimilar competition at bay.

Number 2: Biosimilar developers Momenta and Mylan announced this week that M834, a proposed biosimilar of Orencia, did not meet its primary pharmacokinetic endpoints in a phase 1 study.

Number 1: 54-week results of a phase 3 study in patients with Crohn’s disease support the long-term effectiveness of treatment with the infliximab biosimilar CT-P13.

Finally, this week, The Center for Biosimilars^® launched a new Peer Exchange^TM, titled "Regulation, Policy, and Litigation in Biosimilars." Follow the series to hear insights on the state of biosimilars from the clinical, legal, and product developer perspectives.

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