What a biosimilar is, how FDA, EMA, WHO and other regulators approve one, why information on the global biosimilar landscape is spread across seven regulatory systems, and how the EvySaif Biosimilar Atlas, a free global biosimilar intelligence platform, connects molecules, products, companies, markets and regulatory decisions in one place.
Looking for the data rather than the background? Every approval, holder and pathway across FDA, EMA, MHRA, PMDA, Health Canada, CDSCO and EDE is in the Atlas.
Open the EvySaif Biosimilar Atlas →1. Biological Medicines and the Case for Biosimilars
Biological medicines have changed the treatment of cancer, autoimmune disease, diabetes, inflammatory disorders and rare conditions. They are also among the most expensive medicines in use, and the cost of biological treatment remains a barrier to access in many health systems.
As reference biologics lose patent and data exclusivity, biosimilars introduce competition for molecules that previously had a single supplier. The World Health Organization revised its guidelines on the evaluation of biosimilars in 2022, in line with World Health Assembly resolution WHA67.21 on access to biotherapeutic products, with the stated aim of greater flexibility and a reduced regulatory burden while maintaining quality, safety and efficacy.1
The number of biosimilar developers, products, submissions and approvals has grown to the point where the landscape itself is difficult to follow. Information on any given molecule is spread across regulatory agencies, company pipelines, trial registries, scientific literature and commercial intelligence services, and each source covers only part of the picture. This information gap led EvySaif to build the EvySaif Biosimilar Atlas, a global biosimilar intelligence platform that links molecules, products, companies, markets and regulatory decisions in one place. With seven regulators, 32 reference molecules and 697 verified regulatory records, and free public access, it is one of the most comprehensive biosimilar resources available on the internet, and the sections below describe both the landscape it covers and the way it can be used.
2. What Is a Biosimilar?
A biosimilar is a biological product that is highly similar to an already approved biological product, known as the reference product, and has no clinically meaningful differences from that reference product in terms of safety, purity and potency.2 The US Food and Drug Administration (FDA) applies this definition under section 351(k) of the Public Health Service Act, allowing minor differences in clinically inactive components.2 The European Medicines Agency (EMA) describes a biosimilar as a biological medicine highly similar to another already approved biological medicine, evaluated according to the same standards of quality, safety and efficacy that apply to all biological medicines in the European Union.3
A biosimilar differs from a generic of a small-molecule drug. Small-molecule medicines are chemically synthesized, so a generic manufacturer can reproduce the same active ingredient exactly. Biological medicines are much larger, structurally complex proteins produced in living cells, and the manufacturing process introduces inherent molecular variability between batches, even for the reference product itself.3 A biosimilar is therefore not expected to be an identical copy. The scientific and regulatory objective is to show that any differences between the biosimilar and the reference product have no effect on clinical performance.
For a detailed guide to evidence requirements in each major jurisdiction, see the EvySaif pillar on biosimilar development strategy and regulatory requirements.
3. How Biosimilars Are Developed and Approved
Biosimilar development follows a stepwise comparability exercise. Development begins with extensive analytical and functional characterization of the proposed biosimilar against the reference product, covering structure, purity, biological activity and product-related variants. Depending on the molecule and the regulator, this is followed by comparative non-clinical studies, comparative pharmacokinetic and, where relevant, pharmacodynamic studies, an immunogenicity assessment and, when residual uncertainty remains, a comparative clinical study.2,3
EMA describes comparability as a stepwise process tailored to each product, in which the results of the quality comparability studies determine the extent and type of non-clinical and clinical studies required at the next stage.4 FDA applies the same principle under a totality-of-evidence approach: structural and functional similarity, pharmacology, immunogenicity and, when needed, additional clinical evidence are assessed together rather than as independent hurdles.2
The developer does not repeat the full development program that established the safety and efficacy of the reference product. The developer generates enough comparative evidence to establish biosimilarity and to resolve any remaining uncertainty. This approach reduces unnecessary duplication of clinical trials while maintaining the same approval standards as any other biological medicine.
EvySaif prepares biosimilar regulatory strategy and gap assessments that map a development program against the evidence expectations of the target regulators before the comparability package is finalized.
4. Why Biosimilars Matter Beyond Price
Cost is the most visible reason for biosimilar development, but the significance of biosimilars extends further. Biosimilar competition widens the supply base for a molecule, adds treatment options in areas where a single product previously dominated, and can improve continuity of supply. The therapeutic areas most affected are oncology, rheumatology, gastroenterology, dermatology, diabetes, osteoporosis and ophthalmology, where biologics account for a large share of treatment cost.
Regulatory approval alone does not guarantee uptake. The real-world impact of a biosimilar depends on reimbursement and procurement policy, prescribing behavior, physician and patient confidence, interchangeability and substitution rules, competition from other biosimilars, manufacturing capacity and market access. These factors vary by country, which is one of the main reasons the biosimilar landscape has become difficult to read from any single vantage point.
5. The Global Biosimilar Landscape Is Fragmented
A single reference molecule can have many biosimilar developers, many products, many regulatory submissions and different approval statuses in different countries. The same biosimilar can carry different brand names, follow different regulatory pathways and hold different market statuses depending on the jurisdiction. The product a US clinician knows by one name may be sold under another name in Europe and licensed under a third in India.
There is no universal regulatory database for biosimilars. FDA maintains the Purple Book, a searchable database of FDA-licensed biological products that identifies biosimilars and interchangeable biosimilars and their reference products.5 EMA publishes European public assessment reports and a medicines data table for products authorized in the European Union.3 The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, Health Canada, the Central Drugs Standard Control Organization (CDSCO) in India and the Emirates Drug Establishment (EDE) in the United Arab Emirates each maintain their own lists, formats and terminology.
Each of these systems answers questions about its own market. Understanding the competitive landscape for a molecule across markets requires connecting all of them, and the connecting step is where most of the research time is spent. The market-by-market matrix in the Atlas shows, for every molecule, which of the seven regulators has approved a biosimilar and which has not.
6. Biosimilar Interchangeability in the United States and the European Union
Interchangeability is the area where biosimilar terminology causes the most confusion, because the same word has different meanings in different regulatory systems.
In the United States, an interchangeable biosimilar is a biosimilar that meets additional requirements and may, depending on state pharmacy law, be substituted for the reference product at the pharmacy without the intervention of the prescribing healthcare professional.6 A company must specifically request the interchangeable designation, and not all approved biosimilars hold it.6
The European Union takes a different approach. In a joint statement in 2022, EMA and the Heads of Medicines Agencies confirmed that biosimilars approved in the EU are interchangeable with their reference medicine or with an equivalent biosimilar, while decisions on prescribing and pharmacy-level substitution remain a matter for each member state.7
The result is that "approved", "interchangeable" and "substitutable" cannot be treated as a single universal status field. Each has to be read in the context of the regulator that used it. The US interchangeable biosimilars page in the Atlas lists the products that hold the FDA designation, with the date of each decision.
7. What a Biosimilar Landscape Assessment Requires
A landscape assessment of a single molecule needs, at minimum, the following linked information: the developer of each biosimilar product, the regulators that have approved it, the date and pathway of each approval, the brand names used in each market, the products still under review or in development, the interchangeability status where such a designation exists, and the number of competing products in each market.
These items are related, but the answers rarely sit in one source. A regulatory database gives approval status without company portfolio context. A company pipeline page gives development status without regulatory dates. A commercial intelligence subscription may cover pipelines in depth but sits behind a paywall and is organized around its own taxonomy.
A useful biosimilar intelligence resource lets the reader start with a molecule and move to its products, from a product to its company, from a company to its portfolio across molecules and markets, from a molecule to the markets where products are approved, and from a market to its competitive environment. Those relationships between molecule, product, company, market and regulator are what turn a list of records into intelligence.
8. The EvySaif Biosimilar Atlas: One of the Most Comprehensive Biosimilar Intelligence Platforms Available
The EvySaif Biosimilar Atlas was built to bring the fragmented biosimilar landscape into one connected, searchable resource. Instead of treating each biosimilar as an isolated product record, the Atlas connects the pieces of information that make up its wider landscape.
The Atlas covers 32 reference molecules, 296 development products, 697 regulatory records and 90 companies, with regulatory information mapped across seven regulators: FDA (United States), EMA (European Union), MHRA (United Kingdom), PMDA (Japan), Health Canada, CDSCO (India) and EDE (United Arab Emirates). Every regulatory record is taken from the regulator's own published list or database, and each page shows the month the data was last checked.
Three features together set the Atlas apart from other public biosimilar resources. It covers seven regulators in one register, where most public sources cover a single agency. It links every record to the molecule, product, company and market it belongs to, so the reader moves between them rather than searching each separately. And it is free to use, with no subscription, login or paywall. Taken together, these make the Atlas one of the most comprehensive biosimilar databases openly available today.
A global biosimilar intelligence platform, free to use
Every approval traced to the regulator's own source. Browse by molecule, product, company, market, competition or US interchangeability.
Open the EvySaif Biosimilar Atlas →The Atlas can be explored from six entry points.
Molecules
Each molecule page describes the reference product, its mechanism and indications, and lists every biosimilar recorded for that molecule with its regulatory status in each of the seven markets, an approvals-by-year chart, a pathway-by-market table and a developers-by-market grid.
Products
Each product page follows a single development product across markets, showing the brand names used, the holder in each jurisdiction, the approval date and status per regulator and, for US products, the Purple Book marketing status and interchangeability information.
Companies
The company pages show each developer's biosimilar portfolio across molecules and markets, so a reader can see which companies are competing on the same molecules.
Markets
The market pages show how biosimilar approval and regulatory activity differ across the seven markets, including a cross-market matrix of which molecules have approved biosimilars in which jurisdictions.
Competition
The competition page ranks molecules by the number of approved products, developers, markets and applications under review, and the comparison page places developers side by side.
Interchangeability
The interchangeable biosimilars page lists the products that hold the FDA interchangeable designation.
The Atlas is designed to provide context around records rather than a larger number of records. Each page answers a different question, and the levels are linked so that a reader can move between them without leaving the site.
9. One Molecule, Many Products: The Adalimumab Example
Adalimumab illustrates the scale of the task. A search for adalimumab biosimilars returns a list of product names, but a landscape assessment needs the developer of each product, the regulators that approved it, the dates of approval, the brand names used in each market, the products that hold US interchangeability, and the way the competitive picture differs between the United States, the European Union, the United Kingdom, Japan, Canada, India and the UAE.
The adalimumab page in the Atlas answers these questions on a single page and links to each product and each company involved. The same structure applies to every other molecule in the Atlas, including trastuzumab, bevacizumab, denosumab, ustekinumab, rituximab, the insulins and the filgrastims.
For a client planning entry into a crowded molecule, EvySaif prepares a molecule landscape report built on the Atlas data, covering competitive density, approval timing by market and the regulatory pathway available in each target country.
10. Why EvySaif Built the Atlas
The Atlas began as an internal research problem. Understanding the biosimilar landscape for a client engagement required moving between regulatory databases, company websites, product information, development records and market-specific sources. The information existed, but it was distributed across different systems and presented in different formats, and assembling it for each molecule took days.
EvySaif built a register to hold this information in one structure, with every record linked to the regulator's own source. As the register grew across molecules, products, companies and markets, it became clear that the same problem faced everyone working in the field, and the register was developed into a public resource.
11. Who Uses a Biosimilar Database
The Atlas is designed for anyone who needs to understand the biosimilar landscape at molecule, product, company or market level.
Pharmaceutical and biotechnology companies use it for competitive landscape assessment, portfolio research and market evaluation before committing to a molecule. Regulatory affairs professionals use it to compare approval activity across jurisdictions and to identify which pathway applies in each target market. Market access and commercial teams use it to identify competitive density and to see where biosimilar activity is concentrated. Medical affairs and scientific teams use it as structured background when assessing a product or therapeutic area. Researchers and academics use it to study biosimilar development across molecules, companies and regulators. Healthcare professionals use it to see the full set of products and regulatory decisions surrounding a biological medicine they prescribe.
EvySaif supports regulatory submissions for biosimilars in India, the United Arab Emirates, the Gulf Cooperation Council, the European Union and the United States, and the Atlas is the starting point for each of those engagements.
12. The Future of Biosimilar Intelligence
The biosimilar landscape will continue to change. New developers will enter, new products will move through development, regulators will issue approvals and update policy, reference products will lose exclusivity, and new markets will become commercially important.
Regulatory approaches are also changing. In March 2026 EMA adopted a reflection paper on a tailored clinical approach to biosimilar development, setting out the conditions under which a comparative efficacy study may be waived in favor of a targeted clinical package based on analytical comparability and a comparative pharmacokinetic study.8 FDA published a draft guidance in October 2025 on the same question for the US pathway.9 Changes of this kind alter the evidence a developer needs and the timing of approvals, and a static list cannot capture them.
Biosimilar intelligence therefore has to be maintained as a living resource. The Atlas is updated as regulators publish new approvals and applications, and each record carries the date it was last checked, so a reader can see how current the information is.
13. Frequently Asked Questions
A generic contains the same chemically synthesized active ingredient as the original small-molecule drug. A biosimilar is a biological product made in living cells that is highly similar to, but not identical to, its reference product, and is approved on the basis of a comparative exercise showing no clinically meaningful differences in safety, purity and potency.
Most major regulators have a biosimilar pathway. The EvySaif Biosimilar Atlas covers FDA (United States), EMA (European Union), MHRA (United Kingdom), PMDA (Japan), Health Canada, CDSCO (India) and EDE (United Arab Emirates). The evidence requirements and terminology differ between them.
In the United States, an interchangeable biosimilar is a biosimilar that meets additional FDA requirements and may be substituted for the reference product at the pharmacy, subject to state law, without the prescriber's intervention. In the European Union, EMA and the Heads of Medicines Agencies consider all approved biosimilars interchangeable with their reference medicine, while substitution rules are set by each member state.
The EvySaif Biosimilar Atlas is a free global biosimilar intelligence platform at evysaif.com/biosimilars/. It currently covers 32 reference molecules, 296 development products, 697 regulatory records and 90 companies across seven regulators, and links each record to its molecule, product, company and market pages. Its breadth of regulators and its open access make it one of the most comprehensive biosimilar resources publicly available.
Each regulatory record is taken from the regulator's own published list or database, such as the FDA Purple Book, the EMA medicines data table, the PMDA approved-biosimilar list, the Health Canada Drug Product Database, the CDSCO permission lists, the EDE registered product directory and the MHRA products database. Each page shows the month the data was last checked.
Yes. The Atlas is a public resource on evysaif.com with no subscription, login or paywall. Organizations that need a deeper assessment can commission a molecule landscape report or a regulatory gap assessment from EvySaif.
Commercial intelligence services track development pipelines, forecasts and market data in depth under subscription. The Atlas focuses on connecting verified regulatory decisions to products, companies and markets in an open format, so that a reader can move from a molecule to its full regulatory picture without a subscription.
The competition page of the Atlas ranks molecules by approved products, developers, markets and applications under review. Adalimumab, trastuzumab, bevacizumab and denosumab are among the most crowded.
14. Working With EvySaif on Biosimilars
EvySaif is a clinician-led medical writing, regulatory affairs and drug clinical development consultancy based in Pune, India, serving pharmaceutical, biotechnology and medical device clients across India, the Middle East and Europe. Alongside the Biosimilar Atlas, EvySaif provides biosimilar landscape research, regulatory gap assessments across FDA, EMA, MHRA, CDSCO and GCC pathways, competitive intelligence and scientific and regulatory writing for biosimilar submissions.
Explore the EvySaif Biosimilar Atlas, the global biosimilar intelligence platform, by molecule, company, market and regulatory status, or contact EvySaif to discuss a biosimilar landscape or regulatory assessment.
References
- World Health Organization. Guidelines on evaluation of biosimilars. Annex 3, WHO Technical Report Series No. 1043. Geneva: WHO; 2022. https://www.who.int/publications/m/item/guidelines-on-evaluation-of-biosimilars--trs-1043--annex-3
- US Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Guidance for Industry. Silver Spring, MD: FDA; April 2015. https://www.fda.gov/media/82647/download
- European Medicines Agency. Biosimilar medicines: overview. https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview
- European Medicines Agency. Biosimilar medicines: marketing authorisation. https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/biosimilar-medicines-marketing-authorisation
- US Food and Drug Administration. Purple Book: Database of Licensed Biological Products. https://purplebooksearch.fda.gov/
- US Food and Drug Administration. 9 Things to Know About Biosimilars and Interchangeable Biosimilars. https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars
- European Medicines Agency and Heads of Medicines Agencies. Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU. 19 September 2022, updated 21 April 2023. https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged
- European Medicines Agency. Reflection paper on a tailored clinical approach in biosimilar development. EMA/CHMP/BMWP/60916/2025. Adopted by CHMP 16 March 2026. https://www.ema.europa.eu/en/documents/other/reflection-paper-tailored-clinical-approach-biosimilar-development_en.pdf-0
- US Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies. Draft Guidance for Industry, October 2025. Docket FDA-2011-D-0605. https://www.fda.gov/media/189366/download
Last reviewed: September 2026. This article is for general information and does not constitute regulatory or legal advice. Regulatory requirements change; the current position should be confirmed with the relevant authority before reliance on any statement in this article.