Eye on Pharma: EU Biosimilar Approval, Launches and Product Returns, Denosumab Switching Data

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.