- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Dr Stephen Hanauer: Why More Studies Assessing Adalimumab Biosimilars in Gastro Conditions Are Needed
Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, shares why his study comparing the safety and efficacy of Cyltezo, an adalimumab biosimilar, with the originator (Humira) matters for patients with gastroenertology conditions.
Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, highlights the importance of his study comparing an adalimumab (Cyltezo) with the refrence product (Humira) patients with gastroenterology conditions.
Transcript
What role can your trial play in improving patient and provider confidence in using adalimumab biosimilars for Crohn disease and ulcerative colitis?
The study actually provides additional reassurance regarding the biosimilarity and the potential of patients switching from either the [reference product] to the biosimilar or substituting the biosimilar from the onset.
Why are more clinical studies on anti-TNF [tumor necrosis factor] medications in gastroenterology conditions needed and how can providers and health systems be better advocates for these types of trials?
Firstly, there still is room for improvement in efficacy within the TNF class. We're not getting 100% remission rates and we know that remission rates can be improved with the addition of immunomodulators for instance, or dose escalation in some situations. In addition, we are seeing newer TNF formulations—for instance, of subcutaneous infliximab—as a maintenance therapy. So, as additional biosimilars are coming out, we also have additional new products of the same class that are being evaluated and offer patients different opportunities, for instance, of intravenous versus subcutaneous formulations at different intervals.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.
