-

Samsung Bioepis Releases Fourth Quarter 2026 Biosimilar Market Report Highlighting Importance of Supply Continuity

  • As of September 2026, a total of 98 biosimilars across 21 unique biological molecules have been approved in the United States (US) with 75 biosimilars (77%) launched in the market
  • Trastuzumab, bevacizumab, infliximab, and pegfilgrastim are maintaining or increasing their Average Sales Price (ASP) across multiple consecutive quarters while holding market share
  • Deep Dive section introduces an exclusive wholesaler interview revealing up to a quarter or more of a wholesaler’s biosimilar portfolio in the US facing supply shortage or restriction – the highest level reported

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today released its Fourth Quarter 2026 Biosimilar Market Report, marking the fifteenth edition of the Quarterly Biosimilar Market Report in the United States (US). The report provides an overview of the market status of all biosimilars available in the US, including approval and launch status, pricing (both Average Sales Price, or ASP, and Wholesale Acquisition Cost, or WAC), and market uptake per molecule. The Deep Dive section in this edition reveals how inventory shortages and distribution stability have become decisive factors in provider purchasing decisions, now rivaling price as a primary consideration in the US biosimilar market.

We analyze key factors contributing to supply constraints, explore how supply chain stability influences product adoption and contracting decisions, and discuss both the challenges and strategic opportunities that biosimilar stakeholders should consider

Share

“The US biosimilar market continues to evolve amid growing emphasis on supply reliability and access stability. Following our previous coverage of policy changes shaping the biosimilar landscape, this edition turns to another critical dimension: the current state of biosimilar supply shortages and the broader implications for supply chain resilience,” said Thomas Newcomer, Senior Vice President and Head of US Commercial, Samsung Bioepis. "We analyze key factors contributing to supply constraints, explore how supply chain stability influences product adoption and contracting decisions, and discuss both the challenges and strategic opportunities that biosimilar stakeholders should consider in building more resilient supply frameworks."

Key highlights from the market analysis:

  • Sustained Market Penetration and Price Relief: Within five years of initial launch, biosimilars across key therapeutic classes achieved an average market share of 55% and generated an average 54% reduction in ASP, underscoring the long-term savings delivered to patients and payers.
  • ASP Recovery in Selected Molecules: Selected biosimilars have maintained recovered ASP levels for two consecutive quarters. This trend was observed in the bevacizumab and ranibizumab markets across Q3 and Q4 2026 — signaling a shift from the historical pattern of continuous price erosion in the biosimilar market.
  • Expanding Footprint Across Specialty Areas: Biosimilars established noticeable quarterly gains across specialty biologics, with eculizumab biosimilar penetration climbing 11 percentage points quarter-over-quarter to reach 46%, while ranibizumab biosimilars advanced to 14% (up 7 percentage points from the prior quarter).
  • Supply Chain Stability as a Critical Market Differentiator: The report’s Deep Dive reveals significant vulnerability in product availability, showing that up to a quarter or more of biosimilars in a wholesaler’s portfolio experienced short or restricted supply on a given day. Healthcare providers and health systems are increasingly prioritizing supply chain resilience and reliable fulfillment alongside competitive pricing when evaluating biosimilar partnerships.

To access the Fourth Quarter 2026 Samsung Bioepis Market Report, please visit HERE.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings (KRX: 0126Z0), Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

Contacts

MEDIA CONTACT – Samsung Bioepis
Yoon Kim, yoon1.kim@samsung.com
Anna Nayun Kim, nayun86.kim@samsung.com

Samsung Bioepis Co., Ltd.

KRX:0126Z0

Release Versions

Contacts

MEDIA CONTACT – Samsung Bioepis
Yoon Kim, yoon1.kim@samsung.com
Anna Nayun Kim, nayun86.kim@samsung.com

Social Media Profiles
More News From Samsung Bioepis Co., Ltd.

Samsung Bioepis and Teva Expand Strategic Partnership to Advance Up to Six Potential Biosimilar Candidates

INCHEON, Korea & TEL AVIV, Israel--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the companies have entered into a global license, development, and commercialization agreement for up to six potential biosimilar candidates, with two confirmed investigational biosimilar candidates, SB41, a biosimilar candidate referencing Fasenra®1 (benralizumab), and SB44, a biosimilar candidate referencing Ilaris®2 (canakinumab). Un...

Samsung Bioepis Releases Third Quarter 2026 Biosimilar Market Report

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today released its Third Quarter 2026 Biosimilar Market Report, marking the fourteenth edition of the Quarterly Biosimilar Market Report in the United States (US). The report provides an overview of the market status of all biosimilars available in the US, including approval and launch status, pricing (both Average Sales Price, or ASP, and Wholesale Acquisition Cost, or WAC), and market uptake per molecule. The Deep Dive section in this...

Samsung Bioepis Relaunches BYOOVIZ® (ranibizumab-nuna) in the United States in Partnership with Harrow

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced the relaunch of BYOOVIZ® (ranibizumab-nuna) in the United States (US), in partnership with Harrow (Nasdaq: HROW). Harrow became responsible for commercialization of BYOOVIZ® (ranibizumab-nuna), a biosimilar referencing LUCENTIS1 (ranibizumab), and OPUVIZ™ (aflibercept-yszy), a biosimilar referencing EYLEA2 (aflibercept), upon full transition of commercialization rights from Biogen back to Samsung Bioepis by the end of 20...
Back to Newsroom