Biosimilars Enter a New Growth Phase: Biologics R&D Trends and Research Opportunities in 2026

Key Takeaways

   • Biosimilars are entering a new predictable growth phase

   • Autoimmune diseases remain a dominant biologics R&D area

   • Several next-generation biologics targeting BAFF, OX40 and IL-36 pathways are approaching key milestones

   • Reliable research reagents remain essential for biologics discovery and validati

BAFF/BAFF-R pathway: Regulates B cell survival and differentiation, pivotal in multiple autoimmune diseases

OX40 co-stimulatory pathway: Involved in T cell activation and immune memory formation

IL-36 inflammatory pathway: Key in psoriasis and other inflammatory skin disorders

BAFF/APRIL dual pathway: Governs antibody production and B cell maturation

3.1 Ianalumab: BAFF-R Targeted B Cell Modulation

Figure 2. Interaction and expression of BAFF.（DOI: 10.1016/j.cyto.2015.07.014）

Developed by Novartis, Ianalumab targets the BAFF receptor (BAFF-R), a key regulator of B cell survival and differentiation. Unlike therapies that only block the BAFF ligand, it directly inhibits BAFF-R while inducing ADCC-mediated depletion of pathogenic B cells. It met primary endpoints in Phase III trials for Sjögren’s syndrome, with additional studies showing benefits in immune thrombocytopenia (ITP), positioning it as a potential first-in-class BAFF-R-targeted therapy.

3.2 Rocatinlimab: T Cell Immunomodulation via OX40

Figure 3. The summary of the impact of the OX40–OX40L interaction on T cell subsets.（Doi: 10.1016/j.apsb.2019.08.010）

Co-developed by Amgen and Kyowa Kirin, Rocatinlimab (AMG-451) targets the T cell co-stimulatory receptor OX40, which sustains pathogenic T cell responses and immune memory. By blocking OX40 signaling, it modulates upstream immune activation. Its Phase III ROCKET IGNITE trial for atopic dermatitis met primary endpoints, delivering meaningful lesion clearance and long-term remission in some patients.

3.3 Imsidolimab: IL-36 Pathway Inhibition

Figure 4. Inflammatory pathways and factors involved in IL-36-associated inflammation in the skin.（DOI: 10.1007/s40259-023-00587-5）

Imsidolimab targets the IL-36 receptor, the critical driver of inflammation in GPP. IL-36 signaling amplifies inflammatory crosstalk between keratinocytes and immune cells, leading to severe neutrophil-mediated skin inflammation. In the Phase III GEMINI-1 study, it achieved rapid and substantial disease control, highlighting its potential as a targeted therapy for this rare and severe condition.

3.4 Atacicept: Dual BAFF/APRIL Targeting

Figure 5. BAFF and APRIL receptor interactions.（DOI: 10.1080/08830185.2016.1276903）

Atacicept is a TACI-Fc fusion protein that simultaneously neutralizes BAFF and APRIL, two key survival factors for B cells and plasma cells. This dual-pathway inhibition enables broader suppression of antibody-mediated immune responses. Clinical studies in IgA nephropathy have shown significant reductions in proteinuria and improved renal biomarkers, demonstrating promising therapeutic potential.

4.1 Industrial and Clinical Value

Improved patient access: Biosimilars reduce treatment costs, increasing availability of high-end biologics and easing financial pressure on healthcare systems and patients.
Technology advancement: Biosimilar R&D demands advanced cell culture, protein purification, and quality control technologies. In turn, this drives technological advancement across the biologics supply chain and fosters the development of local manufacturing capabilities.
Ecosystem development: Biosimilars provide an entry pathway for companies worldwide, cultivating skilled professionals in R&D, manufacturing, and quality assurance, and laying a foundation for the next generation of innovative biologics.

4.2 Research Applications

Biosimilars have become essential research reagents, supporting mechanistic studies, target validation, in vitro and in vivo pharmacology, and bioanalytical method development, providing consistent and reliable materials for biologics innovation.