The Center for Biosimilars® recaps the top stories for the week of November 18, 2019.
Transcript
Hi, I’m Laura Joszt 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 November 18, 2019.
Number 5: The first patients in a phase 3 trial of PB006, a proposed natalizumab biosimilar, have begun to receive the study drug.
Number 4: Samsung Bioepis announced that the FDA has accepted for review a Biologics License Application for SB8, a proposed bevacizumab biosimilar referencing Avastin.
Number 3: While much attention over the past few weeks has been on the US biosimilars market, Canada has also been making strides in its own biosimilars experience.
Number 2: The US market saw the launch of the third biosimilar pegfilgrastim.
Number 1: The FDA approved Pfizer’s adalimumab biosimilar, referencing Humira.
Finally, last week, our e-newsletter asked whether you think that the 10% list price discount for the first US rituximab biosimilar is deep enough to drive uptake.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.