The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 21, 2017.
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 August 21.
Number 5: Stakeholder groups, including the American College of Rheumatology and the Biotechnology Innovation Organization are praising the enactment of the FDA Reauthorization Act of 2017, calling the law critical to bringing biosimilar products to the marketplace.
Number 4: Drug maker Alexion has announced 3 new US patents that will defend its Soliris against biosimilar competition. Alexion also announced that the European Commission has granted the drug an extended indication for myasthenia gravis.
Number 3: A recently published study shows that biosimilar filgrastim is safe, effective, and well tolerated in both primary and secondary prevention of chemotherapy-induced febrile neutropenia.
Number 2: The FDA has signed an agreement to share confidential information, including trade secrets and inspection reports, with European regulators.
And Number 1: The Center for Biosimilars® Peer Exchange®, titled “Clinical Advances and Challenges with Biosimilars,” kicks off with an expert discussion of the adoption of biosimilar treatments in the United States and Europe.
Finally, last week, our newsletter asked you to share your thoughts about how the FDA should address the deficiencies it observed at Biocon’s manufacturing facility. To view results of the poll, follow The Center for Biosimilars® on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.