The Center for Biosimilars® recaps the top stories for the week of March 16, 2020.
Hi, I’m Christina Mattina 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 March 16, 2020.
Number 5: Schiff Hardin patent attorney, Imron T. Aly, works with India-based manufacturers of biologics and says supply chain problems are anticipated shortly in the United States, based on changes in FDA inspection policy and sourcing issues.
Number 4: Even as the first bevacizumab biosimilar gained approval for marketing in China, data emerged from a phase 1 pharmacokinetic study comparing the biosimilar with its reference product (Avastin).
Number 3: In light of the COVID-19 outbreak, the FDA has suspended foreign inspections of FDA-regulated manufacturing plants and products. Meanwhile, escalating foreign travel restrictions put a damper on growth of the biosimilars industry.
Number 2: Teva Pharmaceuticals USA and Celltrion Healthcare have launched the fourth trastuzumab biosimilar, Herzuma, at a 10% discount to the cost of reference product Herceptin
Number 1: A Vizient executive says the difficulty in tracking active pharmaceutical ingredients and the limited requirements for information from manufacturers will make it difficult to respond to the COVID-19 pandemic.
To read all of these articles and more, visit centerforbiosimilars.com.