The Center for Biosimilars® recaps the top news for the week of March 25, 2019.
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 March 25.
Number 5: The FDA's updated guidance on the naming of biologics has caused concern among some proponents of biosimilars, and one stakeholder has now filed a citizen petition with the FDA in which he asks that the guidance be withdrawn.
Number 4: Roche has reached a confidential US patent settlement with Pfizer regarding its brand-name rituximab, Rituxan.
Number 3: Spectrum Pharmaceuticals has withdrawn its Biologics License Application for a novel granulocyte colony-stimulating factor therapy that the company had hoped to sell under the brand name Rolontis.
Number 2: The Department of Justice has issued a letter saying that the Affordable Care Act should indeed be struck down, raising questions about the future of the biosimilar approval pathway.
Number 1: A research letter published this week shows that biosimilars of insulin can generate significant cost savings.
Finally, last week, our e-newsletter asked which policy proposal recently put forward by the Trump administration would most encourage biosimilars.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.