The European Union approves a tocilizumab biosimilar and the US sees another launch, Genentech’s ophthalmology biobetter returns to the market, and Samsung Bioepis shares data on switching to its denosumab biosimilar.
The European Union approves a tocilizumab biosimilar and the US sees another launch, Genentech’s ophthalmology biobetter returns to the market, and Samsung Bioepis shares data on switching to its denosumab biosimilar.
EU Approval for a Tocilizumab Biosimilar
Biogen announced that the European Commission (EC) has approved Tofidence, a tocilizumab biosimilar monoclonal antibody referencing Roactemra (Actemra in the US). Tofidence’s intravenous formulation has been authorized for treating moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. The EC approval was based on extensive analytical, nonclinical, and clinical data demonstrating Tofidence’s comparability with the reference biologic. Studies confirmed its similar pharmacokinetics, safety, and immunogenicity. Biogen has exclusive commercialization and marketing rights to Tofidence outside of China as part of a partnership with Bio-Thera Solutions, which serves as the product’s developer and manufacturer.
Tyenne Launch and the Market Return of a Biobetter
Fresenius Kabi announced the launch of the subcutaneous version of Tyenne (tocilizumab-aazg), the first tocilizumab biosimilar with both intravenous and subcutaneous formulations approved by the FDA. The new formulation, available in a prefilled syringe and autoinjector, offers increased access and affordability for US patients with chronic autoimmune diseases. Tyenne is Fresenius Kabi's third biosimilar in the US and second in its immunology portfolio. The biosimilar, approved by the FDA in March 2024 and launched as an intravenous formulation in April 2024, has shown similar safety and tolerability to the reference product in trials.
Additionally, Genentech reintroduced Susvimo, an intravitreal use via an ocular implant utilizing reference ranibizumab (Lucentis) for treating wet age-related macular degeneration (AMD) in the US. This follows the end of a voluntary recall and FDA approval of a post-approval supplement to the biologics license application, which includes updates to the ocular implant and refill needle. Genentech recalled Susvimo in 2022 due to performance issues but has since updated the implant and needle, ensuring they meet performance standards and improving the manufacturing process.
The implant, approved by the FDA in 2021, is surgically inserted during an outpatient procedure and refilled every 6 months. The product is also a biobetter, which is a class of follow-on biologic products that are intentionally altered to improve clinical effects, allow for more time in between doses, or enhance tolerability.
Denosumab Switching Data
Samsung Bioepis presented follow-up results from a phase 3 study on SB16, a proposed biosimilar to Prolia/Xgeva (denosumab), at the 2024 European Calcified Tissue Society Congress. The randomized, double-blind study showed that SB16 and reference denosumab remained comparable in efficacy, pharmacokinetics, pharmacodynamics, safety, and immunogenicity up to month 18, including during a switching period.
Patients with postmenopausal osteoporosis were initially randomized to receive either SB16 (SB16+SB16) or reference denosumab (DEN+DEN). Patients taking the reference agent were re-randomized at month 12 to continue their treatment or switch to the biosimilar (DEN+SB16).
The follow-up demonstrated that switching to SB16 from reference denosumab was comparable up to month 18. The mean percent change from baseline in lumbar spine bone mineral density (BMD) at month 18 was similar between treatment groups. The least squares mean (LSM) of percent change from baseline in lumbar spine BMD at month 18 was 6.77% (standard error, 0.286) for SB16+SB16. The LSM difference in lumbar spine BMD change for the full analysis set was –0.03% (90% CI, –0.85 to 0.79) between SB16+SB16 and DEN+DEN, and –0.52% (90% CI, –1.48 to 0.43) between the DEN+SB16 and DEN+DEN groups.
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.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
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.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis
October 19th 2024A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.
Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.