The Center for Biosimilars® recaps the top news for the week of December 10, 2018.
Transcript:
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 December 10.
Number 5: Novartis recently announced that ligelizumab is moving on to phase 3 trials after demonstrating a clear dose-response relationship and improvements over another one of its older products, omalizumab.
Number 4: Since biosimilar filgrastim became available, patient access to the treatment has improved in many regulatory markets, but concerns still remain about whether the United States is keeping place with the rest of the world in biosimilar uptake.
Number 3: Amgen and Entera Bio have announced that they have entered into a research collaboration and license agreement to develop orally administered formulations of biologic drugs.
Number 2: This week, the FDA took significant steps toward a long-awaited transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars.
Number 1: Genentech and Pfizer have filed a collective stipulation and proposed order of dismissal of a patent infringement lawsuit over Genentech’s reference trastuzumab product, Herceptin.
Finally, last week, our e-newsletter asked if you think there will be more developers sponsoring biosimilars of drugs that treat rare diseases.
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.