"We Envision Growth Strategies Most Suited
to Your Business"

U.S. Biosimilars Market to Witness Stellar Growth with Bullish FDA Approvals; Amneal Pharmaceuticals Received the U.S. FDA Approval for RELEUKO to Treat Neutropenia

May 12, 2022 | Healthcare

The U.S. biosimilars market size is anticipated to surge from USD 9.48 billion in 2022 to USD 100.75 billion by 2029. Follow-on biologics have become sought-after as a cost-effective alternative amidst the patent expiry of blockbuster biologics. Prominently, treatment with biosimilars is cheaper than treatment with biologics. The soaring number of approvals from the U.S. FDA will add fillip to the industry growth in the ensuing period.

According to the latest research report by Fortune Business Insights™ titled, U.S. Biosimilars Market Size, Share & COVID-19 Impact Analysis, By Drug Class (Filgrastim & Pegfilgrastim, Monoclonal Antibodies, and Others), By Disease Indication (Cancer, Autoimmune Diseases {Arthritis, Psoriasis, Neutropenia, and Others}, and Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Regional Forecast, 2022-2029,” the market was pegged at USD 6.73 billion in 2021. It is expected to observe a 40.2% CAGR during the forecast period.

COVID-19 Pandemic-led Product Launch Postponement Dented Growth Prospect

While most industries grappled with the COVID-19 pandemic, the healthcare sector exhibited resilience across the U.S. To illustrate, Pfizer’s global biosimilars business reported a revenue of USD 2.34 billion in 2021, with the U.S. contributing approximately 66.6% of the revenue. Meanwhile, postponement of regulatory approval redefined the regional landscape. It was reported that merely two biosimilars were rolled out in FY 2021 compared to six rollouts in 2019 in the U.S. Stakeholders expect the next few years to witness increased approval and product launches.

To get a detailed report summary and research scope of this market, click here:


Coherus Biosciences Received FDA approval for YUSIMRY for Plaque Psoriasis Treatment

Major companies are gearing to boost their portfolios as they compete to bolster their brand position in the U.S. To illustrate, in December 2021, Coherus Biosciences announced the U.S. FDA approved YUSIMRY for the treatment of psoriatic arthritis, plaque psoriasis, juvenile idiopathic arthritis, rheumatoid arthritis, and ankylosing spondylitis. Prominent companies could infuse funds into research and development activities to tap into markets. The U.S. biosimilars market share will observe a notable gain on the back of investment in organic and inorganic strategies.

Strategic Partnerships to Underpin Regional Growth

Industry players are likely to cash in on the clinical upsides as the penetration of the drug continues to gain traction across the region. Drug-makers are expected to ink a strategic deal to boost the product’s commercialization, manufacturing, and development. Specifically, in February 2022, Biocon Biologics inked a deal to acquire Viatris’s biosimilars business to bolster its position through its projected pipeline biosimilar drugs portfolio. The U.S. biosimilars market growth will be pronounced with rising demand to boost the accessibility of the drug. However, prevailing challenges with clinical processing and cost of drug development may challenge leading companies gearing to boost their portfolios.

Stakeholders Emphasize FDA Approvals to Bolster Portfolio

Leading companies are poised to invest in R&D activities, product launches, technological advancements, and mergers & acquisitions to boost their presence across untapped areas. Furthermore, leading companies could infuse funds into innovations to gain a competitive edge in the regional market.

Notable Industry Development

  • March 2022 – Amneal Pharmacueticals, Inc. announced the U.S. FDA approval for RELEUKO to treat neutropenia.

List of the Companies Profiled in the Report

  • Pfizer Inc. (U.S.)

  •  Amgen Inc. (U.S.)

  •  Samsung Bioepis (South Korea)

  • Novartis AG (Switzerland)

  • Celltrion Inc. (South Korea)

  •  Viatris Inc.(U.S.)

  •  Coherus BioSciences (U.S.)

Further Report Findings

  • In terms of drug class, the monoclonal antibodies segment could account for a considerable share of the U.S. market, largely due to increasing FDA approvals and R&D activities.

  • With respect to disease indication, the autoimmune diseases segment will witness a considerable CAGR from 2022 to 2029. The growth is attributed to the rollout of the drug for autoimmune diseases.

  • Hospital pharmacies could exhibit robust growth, owing to easy accessibility and advanced treatment options.

Table of Segmentation



Study Period


Base Year


Estimated Year


Forecast Period


Historical Period



Value (USD billion)


By Drug Class, Disease Indication, and Distribution Channel


By Drug Class

  • Filgrastim & Pegfilgrastim

  • Monoclonal Antibodies

  • Others

By Disease Indication

  • Cancer

  • Autoimmune Diseases

    • Arthritis

    • Psoriasis

    • Neutropenia

    • Others

  • Others

By Distribution Channel

  • Hospital Pharmacies

  • Retail Pharmacies

  • Online Pharmacies

U.S. Biosimilars Market
  • PDF
  • 2021
  • 2018-2020
  • 105


  • 2850

Our Clients

We use cookies to enhance your experience. By continuing to visit this site you agree to our use of cookies . Privacy.