Global Biosimilar Market Sees Structural Shifts, Regulatory Hurdles, and Pipeline Gains

From corporate restructuring to pipeline setbacks and surging market penetration in Asia, recent developments across the biosimilar landscape reflect an industry simultaneously navigating opportunity and regulatory complexity.

Sandoz Creates Unified Biosimilar Unit, Appoints New President

In a major organizational overhaul aimed at capitalizing on what company leaders described as a "golden decade" of opportunity, Sandoz Group AG announced the creation of a dedicated global biosimilar development, manufacturing, and supply unit, according to a press release published on the Sandoz website.1

The company appointed industry veteran Armin Metzger as president of the new division and member of the executive committee. Metzger, who previously held senior roles at Ferring and Merck, is scheduled to officially join the Executive Committee on April 1, 2026.

The initiative was designed to capitalize on anticipated opportunities arising from the upcoming expirations of medical exclusivity, valued at more than USD 650 billion over the next decade. By consolidating all biosimilar activities, such as spanning development, manufacturing, and supply chain under a single executive, Sandoz is hoping to speed decision-making, deepen vertical integration, and tailor strategies to distinct market dynamics.

Concurrent leadership changes included the appointment of Claire D'Abreu-Hayling as president of generics development and Glenn Gerecke as president of generics manufacturing and supply, effectively separating the generics and biosimilars businesses under specialized leadership. Sandoz posted full-year 2025 revenue of $11.09 billion, with biosimilar sales growing 13% at constant currency to $3.29 billion, representing 30% of total revenue, underscoring why the company moved to sharpen its structural focus on the segment.

Outlook Therapeutics Evaluates Options After FDA Type A Meeting on Bevacizumab Candidate

In contrast to Sandoz's forward momentum, Outlook Therapeutics stated that it was still weighing its regulatory options for its bevacizumab ophthalmic candidate following a Type A meeting with the FDA, as reported by Pearce IP.2

The Type A meeting was held to clarify the outstanding issue identified in the complete response letter (CRL), issued December 30, 2025, regarding substantial evidence of effectiveness for ONS-5010/LYTENAVA (bevacizumab-vikg)—and to discuss potential paths forward for regulatory approval. The biologics license application (BLA) had been submitted for the treatment of wet age-related macular degeneration (wet AMD).

Outlook Therapeutics stated it was evaluating available regulatory options to advance ONS-5010/LYTENAVA toward potential US approval, noting that the product demonstrated clinically meaningful and statistically significant improvements in visual acuity in the NORSE TWO randomized, double-masked, active-controlled phase 3 trial, which met its primary and key secondary end points.

The company noted that if approved, ONS-5010/LYTENAVA would be the first FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, FDA-approved labeling, and robust pharmacovigilance. The product has already received marketing authorization in Europe and was commercially launched in Germany, Austria, and the United Kingdom for wet AMD treatment, providing some commercial foundation as the company navigated the US regulatory path.

Celltrion Biosimilars Achieve Dominant Shares Across Asian Markets

While others grappled with structural or regulatory challenges, Korean biopharmaceutical company Celltrion reported strong commercial gains across Southeast Asia and other key Asian markets, according to Korea BioMedical Review.3

The company said it drove prescription growth in Malaysia, Singapore, Thailand, and Hong Kong through tender wins and localized sales strategies, with several key product lines achieving leading market shares.

Celltrion's flagship infliximab biosimilar, Remsima, held market shares of 93% in Singapore, 77% in Hong Kong, 73% in Thailand, and 65% in Malaysia as of the third quarter of 2025, according to IQVIA, a pharmaceutical market research firm.

Performance extended beyond autoimmune disease. Herzuma (trastuzumab), a treatment for people with breast and gastric cancer, held prescription shares of 87% in Thailand, 57% in Hong Kong, and 51% in Malaysia as of Q3 2025, while Truxima (rituximab), a treatment for people with blood cancers, maintained leading prescription shares of 90% in Singapore and 79% in Thailand.

Celltrion's adalimumab biosimilar, Yuflyma, was also gaining ground, surpassing its originator product to become the second-most prescribed treatment for people with autoimmune conditions in Singapore. Looking ahead, Celltrion's Thai subsidiary announced plans to launch 3 new biosimilars in 2026—ustekinumab, bevacizumab, and omalizumab—to build on its existing portfolio of 5 marketed products in the country.

References

1. Sandoz Group AG. Sandoz creates new global biosimilar development, manufacturing and supply unit, appoints industry veteran Armin Metzger to lead next phase of growth. Published March 10, 2026. Accessed March 10, 2026. https://www.sandoz.com/sandoz-creates-new-global-biosimilar-development-manufacturing-and-supply-unit-appoints-industry
2. Pearce IP. Outlook Therapeutics provides update regarding bevacizumab biosimilar after Type A FDA meeting. Published March 5, 2026. Accessed March 10, 2026. https://www.pearceip.law/2026/03/05/outlook-therapeutics-provides-update-regarding-bevacizumab-biosimilar-after-type-a-fda-meeting/
3. Lee H. Celltrion biosimilars secure leading share in key Asian countries. Korea BioMedical Review. Published March 9, 2026. Accessed March 10, 2026. https://www.koreabiomed.com/news/articleView.html?idxno=30850