We sat down with Sarfaraz Niazi, PhD, an adjunct professor and biosimilar industry expert, to discuss the potential impact high-concentration adalimumab products could have on the US market.
Reference adalimumab (Humira), developed by AbbVie was approved by the FDA in December 2002 and quickly became a blockbuster drug used to treat 12 rheumatic and inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Biosimilar competition overseas has eroded much of AbbVie’s international market share. Humira’s patent thicket and settlements have shielded the drug from US market competition posed by biosimilars until 2023. Additionally, AbbVie developed and received approval for a high-concentration, citrate-free formulation, which has rapidly become the dominant form of adalimumab, posing an additional challenge to biosimilar competitors.
However, Celltrion Healthcare and Alvotech are positioning themselves to be the leaders in high-concentration, citrate-free adalimumab biosimilars, with Celltrion getting the greenlight Yuflyma in mid-February 2021 from the European Union to enter the market. With new versions of adalimumab on the horizon, what will this mean for the market and the biosimilars already marketed and in the US’ pipeline?
We sat down with Sarfaraz Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of Karyo Biologics, Adello Biologics, and PharmSci, to discuss the implications for the adalimumab market and patients.
To learn more about Celltrion's EU approval, click here.
To learn more about Alvotech’s high concentration adalimumab, click here.
To learn more about high-concentration citrate-free adalimumab products, click here.
To learn about the patent dance, click here.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
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.
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
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.
Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data
November 5th 2024Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.