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Not So Different: Sarfaraz Niazi, PhD Discusses Market Projections For High-Concentration Adalimumab Biosimilars
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.
Adalimumab Biosimilar Switching Policy Shows Long-Term Success in IBD
February 26th 2025Patients with inflammatory bowel disease (IBD) who switched from reference adalimumab (Humira) to a biosimilar under a mandatory nonmedical switching policy maintained long-term safety, efficacy, and treatment persistence comparable to those who remained on the originator drug, according to a Canadian study.
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.
Resolution of Injection Site Reactions After Switching to Adalimumab Biosimilar
February 22nd 2025A 15-year-old girl with ulcerative colitis who developed injection site reactions to the adalimumab reference product was successfully switched to the biosimilar LBAL without recurrence of symptoms, demonstrating the safety and effectiveness of switching for medical reasons, likely due to an allergic reaction to an excipient in the originator.
Biosimilars in Action: Market Shifts, Legal Insights, and FDA Approvals
February 9th 2025In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.
