Biosimilars

Bringing Life-Saving Biologics to More Patients

Overview

Biosimilars are a class of biological medicines that are designed to mimic existing and approved biological medicines, known as reference products. These products are made from large complex molecules derived from living cells or organisms and manufactured under controlled settings. They include gene therapies, stem cell therapies, and monoclonal antibodies and are often more effective than chemically synthesized medicines in treating serious conditions like cancer and autoimmune diseases.

In 2010, the FDA began regulating biosimilars, enabling their commercialization after the reference product's patent expired. To meet FDA approval, biosimilars must satisfy two key criteria—they must be functionally and structurally similar to the reference product and must not differ clinically from the reference product in any meaningful way. Biosimilars offer a lower-cost alternative to original biological products. They also provide patients with more options while increasing competition in the pharmaceutical industry.

Biosimilar players can be broadly categorized into pure play and diversified drug developers, specialized testing and technology providers, and contract development and manufacturing providers.

Note: Additional sections (market sizing, detailed overview, incumbents, etc.) can be provided on request.

Market Mapping


Incumbents
Growth
Early
Seed
Pre-Seed
Diversified Drug Developers
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Pure Play Biosimilars Developers
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Contract Development and Manufacturing Organizations
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Technology and Support Service Providers
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Testing Services
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Biopharmaceuticals
Biopharmaceuticals
Biopharmaceuticals
Biopharmaceuticals
Biopharmaceuticals

The Disruptors


Funding History

Notable Investors


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Industry scope 

This industry focuses on companies involved in the R&D, manufacturing, and commercialization processes of biosimilars, which includes: 
  1. Pure play biosimilar developers involved in the R&D, production, and commercialization of only biosimilars. They have the necessary expertise to manufacture these complex biological molecules and must adhere to strict regulations and guidelines to ensure quality and safety
  2. Diversified drug developers that are biotech companies involved in the R&D, production, and commercialization of biological drugs including biosimilars
  3. Testing services that provide solutions to support the biological characterization, comparability, and other clinical assessments required to adhere to strict regulations and guidelines governing biosimilars
  4. Contract biosimilar developers and manufacturers that provide outsourced R&D services and manufacturing sites with controlled settings for biosimilar companies
  5. Technology and support service providers, including companies that provide biopharmaceutical technology development and support services to biosimilar drug developers
However, we exclude the following areas when selecting companies for this industry:
  1. Companies that develop original biological medicines (covered under Precision Medicine, Human Gene Editing, and Regenerative Medicine)
  2. Companies that develop biobetters, since they are modified to improve safety and efficacy and patented, unlike biosimilars
Currently, we do not actively cover this industry, but we have identified it as a potential industry to add to our coverage. For the list of industries in our coverage, please visit https://sp-edge.com/industries
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