The Center for Biosimilars® recaps the top news for the week of August 20, 2018.
Hi, I’m Samantha DiGrande 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 August 20.
Number 5: A Japanese company has launched Celltrion’s trastuzumab biosimilar in Japan, but the product will only be sold to treat HER2-positive gastric cancers.
Number 4: The FDA has granted priority review for Alexion’s proposed long-acting C5 complement inhibitor that could help stave off biosimilar competition for the Soliris market.
Number 3: A new paper in BioDrugs argues that phase 3 studies may no longer be necessary for biosimilars.
Number 2: The United Kingdom’s National Institute for Health and Care Excellence says that it does not recommend Perjeta for routine use after surgery in patients with breast cancer, even though using the drug in combination with biosimilar trastuzumab could reduce the total cost of treatment.
Number 1: Pfizer’s proposed adalimumab biosimilar demonstrated similar efficacy, safety, and immunogenicity profiles to the reference Humira at 26 weeks of treatment in patients with rheumatoid arthritis.
Finally, last week, our e-newsletter asked whether you think that the United States’ patent system needs reform to prevent abuse by drug makers.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.