Biosimilars Market Updates

Skyquest Technology's expert advisors continuously track and analyze the latest developments and updates related to biosimilars market. Our team of analysts stay abreast of all the recent news stories shaping the industry including new product launches by major companies, strategic partnerships, M&As, Patent filings and industry and regulatory developments.

Biosimilars Market News

Biosimilars, which are highly like already approved biologic medicines, offer significant cost savings—usually between 30% and 70%—with the same efficacy and safety. Regulatory bodies like the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), are trying to simplify approvals, bringing these treatments within reach of patients across the globe.

  • In December 2024, Biocon Biologics received U.S. FDA approval for Yesintek (ustekinumab-kfce), a biosimilar for chronic inflammatory conditions like plaque psoriasis and Crohn's disease. The approval strengthens Biocon's presence in the U.S. market, providing an affordable option to branded biologics, and solidifying the company's position in making global biosimilar accessibility and affordability.
  • In October 2024, Accord Healthcare had the European Medicines Agency (EMA) approve its biosimilar Imuldosa (ustekinumab-srlf). This biosimilar is indicated for the treatment of chronic inflammatory diseases, such as plaque psoriasis and Crohn's disease. The approval reinforces Accord Healthcare's position in the Europe biosimilars market, driving competition and broadening treatment access for patients.

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Global Biosimilars Market size was valued at USD 24.3 billion in 2023 and is poised to grow from USD 28.38 billion in 2024 to USD 98.31 billion by 2032, growing at a CAGR of 16.8% during the forecast period (2025-2032).

Global biosimilars market is highly competitive, with major pharmaceutical and biotech companies actively expanding their portfolios. The leading biosimilar companies invest in R&D, strategic alliances, and regulatory clearance to capture market share. Some of the notable contributors include Pfizer, Novartis (Sandoz), Amgen, Biocon Biologics, Samsung Bioepis, and Celltrion. These players use cutting-edge manufacturing, biosimilar interchangeability strategies, and competitive pricing to battle in the market. Some of the upcoming players such as Alvotech, Coherus BioSciences, and Polpharma Biologics are also emerging, making a difference through innovation and affordability. As biosimilar adoption increases, competition intensifies, fostering market growth and affordability of biologic treatments globally.'Sandoz', 'Biocon Biologics', 'Celltrion Healthcare', 'Amgen Inc.', 'Pfizer Inc.', 'Samsung Biologics', 'Viatris', 'Teva Pharmaceutical Industries', 'Fresenius Kabi', 'Coherus BioSciences', 'Alvotech', 'STADA Arzneimittel AG', 'Reliance Life Sciences', 'Dr. Reddy’s Laboratories', 'Novartis AG', 'Formycon AG', 'Intas Pharmaceuticals', 'BIOCAD', 'mAbxience', 'Apotex Inc'

The growing prevalence of chronic diseases like cancer, diabetes, and autoimmune diseases is propelling the need for cheap biologic treatments. Biosimilars ensure cheaper substitutes to pricey biologics, enhancing patients' access to life-sustaining medicines. This surging demand for long-term therapeutic solutions continues to boost uptake for biosimilar drugs.

Short-Term: Regulatory bodies such as the FDA and EMA are simplifying biosimilar approval procedures, resulting in more market entries. Faster approvals encourage competition, driving down costs and expanding accessibility. Healthcare providers and payers are more inclined to adopt biosimilars, causing a surge in market penetration and reshaping pricing strategies for both originator biologics and biosimilars.

Why is North America Dominates Biosimilars in 2024?

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Global Biosimilars Market
Biosimilars Market

Report ID: SQMIG20I2389

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