The Top 5 Biosimilars Articles for the Week of September 4

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 September 4.

Number 5: A recent analysis shows that biologic agents represent the highest single cost associated with infusion therapy for rheumatoid arthritis patients.

Number 4: Drug maker USV announced that it has successfully completed phase 1 and phase 3 studies on a proposed pegfilgrastim biosimilar. The company expects to submit data to the European Medicines Agency before the end of the year.

Number 3: The European Association of Hospital Pharmacists recently released a position paper on biosimilar medicines. The paper contains marked contrasts to the FDA’s current thinking about biosimilars in the United States.

Number 2: This week, state governors and insurance commissioners testified before the US Health, Education, Labor, and Pensions Committee on stabilizing the Affordable Care Act marketplace.

Number 1: Drug maker Celltrion has received the FDA’s Form 483 after a recent inspection of its manufacturing facility. The form notes 12 observations that include problems with vial stoppers of injectable drugs and visible particulate in products.

Finally, last week, our newsletter asked you to share your thoughts about whether the FDA’s recent approval of a second adalimumab biosimilar is likely to influence prescribing behavior. To view results of the poll, visit The Center for Biosimilars® on LinkedIn.

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