Gastroenterology

Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars

March 17th 2024

By Skylar Jeremias

On 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.

Adalimumab Expenditures in Countries With and Without Available Biosimilars

March 16th 2024

By Deana Ferreri, PhD

Article

A recent study used difference-in-difference analysis to assess adalimumab sales volumes and expenditures in 6 countries with and 8 countries without available biosimilar adalimumab products.

Posters From AMCCBS and AAD Showcase New Technology for Biosimilar Uptake, Barriers to Self-Injectable Biologics

March 14th 2024

By Skylar Jeremias

Article

Posters from Association of Cancer Care Centers 50th Annual Meeting and Cancer Center Business Summit (AMCCBS) and the American Academy of Dermatology (AAD) highlight the benefits of incorporating biosimilars into electronic medical records and the biggest barriers for home injection of biologics.

Review: Real-World Evidence Confirms Effectiveness and Safety of Adalimumab Biosimilar SB5

March 9th 2024

By Deana Ferreri, PhD

Article

The adalimumab biosimilar SB5 was reported to be as safe and effective as the reference product in a review of randomized controlled trials and real-world studies on immune-mediated inflammatory diseases.

FDA Green Lights Second Tocilizumab Biosimilar

March 7th 2024

By Skylar Jeremias

Article

The FDA has approved Fresenius Kabi's tocilizumab biosimilar (Tyenne; tocilizumab-aazg), making it the second tocilizumab biosimilar overall and first tocilizumab biosimilar to be approved with both intravenous and subcutaneous administration options.

Eye on Pharma: Canadian Aflibercept Settlement; Sandoz Acquires Cimerli; Payer Chooses Cyltezo

March 6th 2024

By Skylar Jeremias

Article

Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.

Patterns of Treatment With Biologics in Patients With Crohn Disease

March 2nd 2024

By Deana Ferreri, PhD

Article

A retrospective study analyzing 3 years of treatment patterns for patients with Crohn disease on biologics found that while more patients received infliximab, adalimumab, and vedolizumab initially, ustekinumab showed the highest persistence and lowest dose escalation rate, indicating potentially better clinical response compared to other biologics.

Cardinal Health Report Showcases Biosimilar Growth, Provider and Payer Evolution, and More

February 29th 2024

By Skylar Jeremias

Article

In its annual biosimilars report, Cardinal Health provided updates on how provider acceptance growth, evolving payer dynamics, and the growing pipeline for biosimilars will shape the biosimilar landscape over the next 5 years.

Samsung Bioepis Announces New Biosimilar Partnership, Regulatory Updates

February 27th 2024

By Skylar Jeremias

Article

Samsung Bioepis provided multiple updates on its biosimilar projects, including a new partnership for its aflibercept biosimilar candidate as well as regulatory news in the European Union and Republic of Korea.

FDA Approves 10th Adalimumab Biosimilar, Simlandi

February 24th 2024

By Skylar Jeremias

Article

After receiving 3 complete response letters, Alvotech has officially received US approval for its adalimumab biosimilar (AVT02; Simlandi), making it the first approval for the company, the 10th biosimilar to reference Humira, and the third interchangeable adalimumab biosimilar.