- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
The Top 5 Biosimilars Articles for the Week of February 12
The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 12, 2018.
Transcript:
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 February 12.
Number 5: On the same day that the President released his budget proposal that called for $2 billion less in funding for the National Institutes of Health than allocated by Congress, a new paper argued that a reduction in funding would significantly delay the emergence of new drugs.
Number 4: Roche has released phase 2 data for a novel drug that could compete with biosimilars of anti-vascular endothelial growth factor therapies.
Number 3: The White House’s Council of Economic Advisors said in a new white paper that the FDA should finalize biosimilar interchangeability guidelines that are easy and inexpensive to adhere to in order to promote competition.
Number 2: South Dakota became the latest state to pass legislation governing the substitution of interchangeable biosimilars for their reference products.
Number 1: Celltrion has received authorization to market its biosimilar trastuzumab, Herzuma, in the European Union.
Also this week, attorneys George Yu and Christopher Bruno, both of Schiff Hardin, explained how the Supreme Court’s eventual decision in the ongoing Oil States case could affect the biologics industry.
Finally, last week, our e-newsletter asked whether the United States should follow Australia’s lead by not using 4-letter suffixes in the names of biosimilars and biologics.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
FDA, EMA Approve Second Pair of Denosumab Biosimilars
February 17th 2025The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.
