Here are the top 5 biosimilar articles for the week of November 21, 2022.
Hi, I’m Skylar Jeremias 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 biosimilar articles for the week of November 21, 2022.
Number 5: As the US awaits the 2023 launch of adalimumab biosimilars, Biogen announced an injunction against Sandoz over a natalizumab biosimilar, Rani Therapeutics initiated a development program for an oral ustekinumab biosimilar, and Bio-Thera Solutions bagin a phase 3 trial for a secukinumab biosimilar.
Number 4: In Biocon’s second quarter of fiscal year 2023 earnings report, revenues were up 23% year over year (YoY) for the company, largely in thanks to the 34% increase in revenues for biosimilars, which accounted for 42% of the total company revenue.
Number 3: Organon Canada launched 2 biosimilars referencing Avastin (bevacizumab) and Herceptin (trastuzumab), China became the first country to approve a denosumab biosimilar, and Optum Rx, a large pharmacy benefit manager (PBM), said that it will add adalimumab biosimilars to formulary.
Number 2: A review explored the 3 main administration options for pegfilgrastim biosimilars, finding that providers should consider the ease and frequency to which patients will need to travel to a clinic for administration as well as their preferences when choosing a mode of administration.
Number 1: The European Commission granted marketing authorization for Ximluci, the third ranibizumab biosimilar to be approved in the European Union. The product was developed through a partnership between STADA Arzneimittel and Xbrane Biopharma and is expected to launch in early 2023.
To read all of these articles and more, visit centerforbiosimilars.com.
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
February 6th 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
BioRationality: No More Biosimilars—Just Biogenerics
February 3rd 2025Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.