Immunology 2025 Review focused on durable benefit, simplified delivery, and access, with biosimilars and persistence shaping outcomes.

 Similar Biological Medicinal Products (Biosimilars) Market continues its rapid ascent, with valuation reaching USD 25.4 billion in 2024. According to the latest analysis, the market is projected to expand from USD 29.1 billion in 2025 to USD 71.9 billion by 2032, reflecting a CAGR of 12.3% during the forecast period. Biosimilars represent a pivotal innovation in biopharmaceuticals—delivering near-identical therapeutic efficacy to originator biologic drugs at significantly lower costs.

Evidence Supports Safe, Effective Switching to Etanercept Biosimilars    Center for Biosimilars

The second half of 2025 showed pharma and healthcare leaning into partnerships that de‑risk innovation and compress time to market.

2025 endocrinology review of pivotal readouts, approvals, guidelines, safety themes, diagnostics, and key catalysts into 2026.

Objective Biosimilars are helping to reduce the cost burden of treatment and widen patient access to therapies. This multicentre trial compared the efficacy, safety and immunogenicity of the biosimilar aflibercept FYB203 with reference aflibercept in patients with neovascular age-related macular degeneration (nAMD). Methods and analysis Patients aged ≥50 years with newly diagnosed nAMD and a best-corrected visual acuity (BCVA) between 20/40 and 20/200 Snellen equivalent were randomised (1:1) to double-masked treatment with 2 mg FYB203 or EU-approved reference aflibercept by intravitreal injection every 4 weeks for three doses (baseline, weeks 4 and 8) then every 8 weeks up to week 48. The primary efficacy endpoint was the change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8 in the study eye. Therapeutic equivalence of FYB203 and reference aflibercept was demonstrated if, depending on the regulatory requirement with respect to the significance level, the two-sided 90.4% and 95.2% CIs were within the predefined equivalence interval of (–3.5 to 3.5) ETDRS letters. Results A total of 433 patients received treatment with FYB203 (n=215) or reference aflibercept (n=218). Mean improvement in BCVA from baseline to week 8 was 6.6 ETDRS letters with FYB203 and 5.6 ETDRS letters with reference aflibercept, with an estimated mean treatment difference of 1.0 and the two-sided 90.4% CI (–0.3 to 2.2) and 95.2% CI (–0.6 to 2.5) fully contained within the pre-defined equivalence margins, confirming therapeutic equivalence between FYB203 and reference aflibercept. Safety and immunogenicity profiles were similar between groups. Conclusion Although conducted during the COVID-19 pandemic in a potentially vulnerable elderly population and affected by geopolitical disruption in Ukraine, mitigation measures minimised the overall impact of these events. FYB203 demonstrated therapeutic equivalence to reference aflibercept in patients with nAMD, supporting similar clinical performance across all approved indications. Trial registration number Clinicaltrials.gov: NCT04522167; EudraCT: 2019-003923-39.

CivicaScript unveils new low-cost insulin and biosimilars aimed at providing better access for patients dealing with chronic conditions, enhancing affordability.

Japan Insulin Biosimilars Market growth is projected to reach 135.0 USD billion, at a 15.756% CAGR by driving size, share, top company analysis, segments research, trends and forecast report 2025 to 2...

Patent Thickets and Litigation Abuses Hinder all Biosimilars  Association for Accessible Medicines

The U.S. Food and Drug Administration (FDA) has approve […]

More than 7,000 people in England will now be able to access to a life-extending treatment for advanced bowel cancer.

The FDA approval of Boncresa and Oziltus, new denosumab biosimilars, enhances access to treatments for osteoporosis and cancer-related bone loss.

Immunology 2025 Review focused on durable benefit, simplified delivery, and access, with biosimilars and persistence shaping outcomes.

Biosimilars Market is expected to grow from 36.79 (USD Billion) in 2024 to 282.3 (USD Billion) by 2035. The Biosimilars Market CAGR (growth rate) is expected to be around 20.35% during the forecast pe...

US Biosimilars Market share register 8.37 USD Billion in 2024, projected to grow 5.18 % CAGR to reach USD Billion 14.59 during the forecast period 2025 - 2035.

Biosimilars Market is expected to grow from 36.79 (USD Billion) in 2024 to 282.3 (USD Billion) by 2035. The Biosimilars Market CAGR (growth rate) is expected to be around 20.35% during the forecast pe...

2025 endocrinology review of pivotal readouts, approvals, guidelines, safety themes, diagnostics, and key catalysts into 2026.

Biosimilars Training Course: Prepare for the Biosimilar Market Growth As Some of the World's Best-known Biologics Face Patent Expiration in the Coming Years (Online Event: Mar 16th - Mar 17th, 2026) - ResearchAndMarkets.com  The AI Journal

Biosimilars Market is expected to grow from 36.79 (USD Billion) in 2024 to 282.3 (USD Billion) by 2035. The Biosimilars Market CAGR (growth rate) is expected to be around 20.35% during the forecast pe...

The Insomniac Hedge Fund

The Insomniac Hedge Fund

On December 22, 2025, the FDA approved mAbxience and Amneal’s Biologics Licensing Applications (BLAs) for BONCRESA™ (denosumab-mobz) and OZILTUS™...

On December 22, 2025, the FDA approved mAbxience and Amneal’s Biologics Licensing Applications (BLAs) for BONCRESA™ (denosumab-mobz) and OZILTUS™...