Biosimilars: A Shifting Global Landscape

What Are Biosimilars — And Why Do They Matter?

Biosimilars are biological medicines that are highly similar to an already-approved reference biologic — the so-called "originator" — in terms of quality, safety, and efficacy. Unlike generic small-molecule drugs, which can be chemically replicated with near-perfect precision, biologics are large, complex molecules derived from living cells. That complexity means biosimilars are never truly identical to their reference product — but they are clinically equivalent, and that distinction is both scientifically important and commercially transformative.

Why do biosimilars matter? Because biologics dominate the most expensive segments of global healthcare. Drugs like adalimumab (Humira), trastuzumab (Herceptin), and rituximab (Rituxan) have treated millions of patients — and cost health systems tens of thousands of pounds or dollars per patient per year. Biosimilars slash those costs. In markets where biosimilar competition is established, prices for biologic medicines have dropped by 20–80%, unlocking access for patients who previously couldn't be treated and freeing up health budgets for new therapies.

The global biosimilars market reached $30.3 billion in 2024, growing at a compound annual growth rate (CAGR) of 14% since 2020. Projections are even more striking: the market is forecast to grow from approximately $50.31 billion in 2026 to $163.14 billion by 2033 — a CAGR of 18.3%. This is not a niche sector. Biosimilars are rapidly becoming a cornerstone of global pharmaceutical strategy.

The Global Regulatory Landscape for Biosimilars

Key Scientific and Regulatory Challenges

The Business Case: Who's Winning and Why

Career Opportunities: Why Biosimilars Are a Hotbed for Regulatory Affairs Talent

How to Build a Career in Biosimilars Regulatory Affairs

The Road Ahead: What Will Shape Biosimilars in the Next Five Years

Conclusion: A Market Built on Regulatory Expertise

The Global Regulatory Landscape for Biosimilars

1.       United States: The FDA's Maturing Framework

The United States has historically lagged behind Europe in biosimilar adoption — but that is rapidly changing. The Biologics Price Competition and Innovation (BPCI) Act of 2009 created the regulatory pathway under the FDA's 351(k) approval route. However, years of patent litigation, pay-for-delay settlements, and prescriber hesitancy slowed biosimilar penetration in the US market.

Today, the picture looks dramatically different. The US biosimilars market grew at 11% in 2024, driven by:

- Adalimumab biosimilars: With Humira's patents expiring, the FDA approved over a dozen adalimumab biosimilars. By 2025, AbbVie's stranglehold on one of the world's best-selling drugs has been substantially eroded.

- Interchangeability designations: The FDA's interchangeability pathway — which allows pharmacists to substitute a biosimilar for the reference product without physician intervention — has become increasingly important. This designation removes a significant market access barrier and is now a strategic priority for biosimilar developers.

- FDA guidance evolution: The FDA continues to refine its guidance on extrapolation of indications, naming conventions, and post-marketing requirements. Regulatory affairs professionals working in the US market must stay current with an evolving framework that is still finding its footing compared to Europe's more established system.

2.        Europe: The Pioneer Market

The European Medicines Agency (EMA) approved the world's first biosimilar in 2006 — a human growth hormone called Omnitrope. Since then, Europe has built the most mature, most trusted, and most competitive biosimilar market globally. The EMA's scientific guidelines for biosimilar development are widely considered the global gold standard.

Key features of the European landscape include:

- Automatic/substitution policies that vary by member state: Unlike the US, where federal interchangeability applies uniformly, EU member states retain individual authority over substitution. Countries like Germany, France, and the Netherlands have robust substitution policies; others are more restrictive. This creates a complex, country-by-country regulatory affairs challenge.

- Tender systems: Many European countries use national or regional tender systems that intensely compress biosimilar pricing. Winning a tender can mean market dominance; losing one means near-zero access. Regulatory and market access teams must align closely.

- Post-Brexit UK framework: The Medicines and Healthcare products Regulatory Agency (MHRA) has developed its own biosimilar guidance, distinct from the EMA's, since Brexit. Professionals working across EU and UK markets must now navigate two separate, though largely harmonised, regulatory systems.

Europe's biosimilar market grew at 13% in 2024 — faster than the US — and remains the global leader in per-capita biosimilar utilisation.

3.       Emerging Markets: The Next Frontier

While the US and Europe dominate headlines, Latin America, Asia, and Africa represent the next major growth horizon for biosimilars. The potential is enormous — but so are the regulatory challenges.

- India and South Korea are both major biosimilar manufacturers, with regulatory agencies (CDSCO and MFDS respectively) developing increasingly sophisticated approval frameworks. Indian companies like Biocon, Dr. Reddy's, and Samsung Bioepis are now global biosimilar players.

- Latin America: Brazil's ANVISA and Mexico's COFEPRIS have strengthened their biosimilar guidelines, though infrastructure, enforcement, and post-marketing surveillance remain variable. The region's high disease burden and growing middle class make it a strategic priority.

- Africa: With the African Medicines Agency (AMA) becoming operational, there is an historic opportunity to build harmonised regulatory frameworks across 55 member states. Biosimilar access in Africa is currently extremely limited, but regulatory capacity-building is accelerating.

- China: The National Medical Products Administration (NMPA) has dramatically overhauled its biologics and biosimilar regulations, bringing them closer to ICH standards. China's domestic biosimilar pipeline is vast, and the country is simultaneously a major manufacturer and an increasingly important consumer market.

Understanding these diverse regulatory environments is not optional for industry professionals — it is a commercial necessity.

Key Scientific and Regulatory Challenges

1.        The Comparability Exercise

The cornerstone of any biosimilar regulatory submission is the comparability exercise — the systematic demonstration that the biosimilar is highly similar to the reference product in physicochemical properties, biological activity, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical outcomes.

This is a stepped approach:

1. Analytical similarity — comprehensive characterisation using state-of-the-art analytical methods

2. Non-clinical studies — in vitro and/or in vivo studies, with reduced animal testing increasingly accepted by regulators

3. Clinical pharmacology — PK/PD studies in healthy volunteers or patients

4. Clinical safety and efficacy — confirmatory trials, increasingly accepted as comparative rather than placebo-controlled

The regulatory expertise required to design, execute, and submit a robust comparability package is substantial. Regulatory affairs professionals specialising in biosimilars must understand not just the dossier structure, but the science behind it.

2.        Extrapolation of Indications

One of the most contentious areas in biosimilar regulation is indication extrapolation — the practice of approving a biosimilar for all of the reference product's indications, even when clinical data has only been generated in one indication.

Regulators, prescribers, and patient groups continue to debate the appropriateness and limits of extrapolation. Getting it right requires regulatory professionals who understand the scientific rationale, can interpret EMA and FDA guidance documents, and can anticipate how regulators will scrutinise their submissions.

3.        Immunogenicity

All biologics carry a risk of triggering immune responses in patients — a phenomenon called immunogenicity. Regulatory agencies require biosimilar developers to extensively characterise and compare the immunogenicity profiles of their products against the reference biologic, including through long-term post-marketing pharmacovigilance.

Immunogenicity assessment is a growing speciality within regulatory affairs, particularly as the field moves toward more complex molecules like monoclonal antibodies, fusion proteins, and novel biologic scaffolds.

4.        Post-Marketing Surveillance and Traceability

Unlike small molecules, biologics can show subtle differences that only manifest at scale — in large, diverse patient populations over long time periods. This makes post-marketing surveillance (pharmacovigilance) especially critical for biosimilars.

Traceability — being able to identify which specific product (by brand name and batch number) a patient received — is therefore a regulatory requirement in most markets. The EU's pharmacovigilance legislation mandates non-proprietary name plus brand name for prescriptions. This regulatory infrastructure underpins patient safety and is an active area of regulatory policy development.

The Business Case: Who's Winning and Why

1.       Market Leaders

According to the 2025 Global Biosimilars Report, Sandoz, Pfizer, and Amgen dominate approximately 50% of the global biosimilar market. Their dominance reflects the enormous scale required to compete effectively:

- Sandoz (spun out of Novartis in 2023) is the world's largest biosimilars-focused company, with a broad portfolio spanning inflammatory diseases, oncology, and haematology.

- Pfizer brings its biologics manufacturing might and global market access capabilities.

- Amgen (itself a pioneer biologic originator) has pivoted aggressively into biosimilars, leveraging its deep biologics process development expertise.

But the competitive landscape is broadening. Korean companies including Samsung Bioepis and Celltrion, Indian players like Biocon Biologics, and European mid-sized firms are all challenging the established order.

2.        The Patent Expiry Wave

The single biggest driver of biosimilar opportunity remains patent expiry. The coming years will see a wave of high-value biologics losing exclusivity, including:

- Ustekinumab (Stelara) — already seeing biosimilar competition launch in 2025

- Pembrolizumab (Keytruda) — the world's best-selling drug, with patents expiring from the late 2020s

- Dupilumab (Dupixent) — a blockbuster in atopy and asthma

- Natalizumab (Tysabri) — for multiple sclerosis

Each new biosimilar entrant requires regulatory strategy, dossier preparation, regulatory submissions across multiple markets, and ongoing pharmacovigilance management. Every new wave of patent expiries means a fresh wave of regulatory affairs hiring.

3.       Oncology: The High-Stakes Frontier

Oncology biosimilars — for drugs like trastuzumab, bevacizumab, rituximab, and cetuximab — represent the highest-value segment, with oncology therapy holding a 25.12% share of the biosimilar market. The stakes are high because oncology prescribers have historically been among the most resistant to biosimilar substitution. Winning prescriber confidence requires not just regulatory approval, but robust clinical data communication strategies — a challenge that sits squarely at the intersection of regulatory affairs and medical affairs.

Career Opportunities: Why Biosimilars Are a Hotbed for Regulatory Affairs Talent

The biosimilar boom is translating directly into one of the strongest job markets in regulatory affairs in recent memory. Here's where the opportunities lie:

1.        High-Demand Regulatory Roles in Biosimilars

Regulatory Affairs Associate/Manager (Biosimilars) - Dossier preparation and submission management

Regulatory CMC Specialist - Chemistry, Manufacturing and Controls for biologics

Pharmacovigilance Scientist - Safety monitoring and adverse event reporting

Regulatory Intelligence Analyst - Tracking evolving global biosimilar guidelines

Market Access & Regulatory Strategist - Navigating tender systems and pricing frameworks

Labelling & Artwork Manager - Country-specific labelling compliance

2.       Skills Employers Are Looking for Right Now

The 2025 life sciences job market data is clear: employers are prioritising regulatory affairs expertise combined with biologics/biosimilar knowledge. Specifically sought skills include:

- Understanding of ICH guidelines (particularly Q5 series for biologics)

- Knowledge of EMA and FDA biosimilar guidance documents

- Pharmacovigilance and EU GVP module competency

- CTD dossier preparation experience

- Cross-functional collaboration (clinical, CMC, quality, commercial)

- Regulatory intelligence and competitive monitoring

How to Build a Career in Biosimilars Regulatory Affairs

The regulatory affairs profession is not one you can simply walk into without the right foundations — but it is absolutely accessible to science graduates, healthcare professionals, and career changers who are willing to invest in structured, practical training.

1.        What You Need to Get Started

A background in pharmacy, biochemistry, life sciences, medicine, nursing, or a related field is typically the starting point. But the technical regulatory knowledge — the dossier structure, the guideline literacy, the submission management skills — has to be learned specifically.

2.       Training Options: What's Out There (And What Actually Works)

There are several training providers in the regulatory affairs space, but Entry to Regulatory is different — and that difference matters enormously for career changers and new entrants. Rather than academic theory delivered in isolation, Entry to Regulatory focuses on getting you job-ready through real-world application: live work assignments that mirror what you'll actually encounter on the job, mentoring from active regulatory professionals, and dedicated job support designed to bridge the gap between training and employment. It's built specifically for people who don't yet have regulatory experience — exactly the group that academic programmes and professional societies tend to under-serve.

The Road Ahead: What Will Shape Biosimilars in the Next Five Years

Looking forward, several forces will shape the biosimilar landscape through 2030 and beyond:

1. AI and analytical technology — Advanced characterisation tools and AI-assisted comparability assessment are beginning to reshape how biosimilar development evidence packages are constructed. Regulatory agencies are actively developing guidance on AI use in submissions.

2. Complex biosimilars — The next generation of biosimilar development targets more structurally complex molecules: antibody-drug conjugates, gene therapy-adjacent biologics, and multi-domain fusion proteins. These present new regulatory challenges with limited existing guidance.

3. Harmonisation pressure — Industry and regulators are pushing for greater international harmonisation of biosimilar requirements through ICH and the World Health Organization (WHO). Progress is slow but meaningful.

4. Interchangeability expansion — In the US, interchangeability designations will increasingly become the market access baseline rather than a premium, further accelerating biosimilar penetration.

5. Sustainability and manufacturing resilience — Post-pandemic supply chain vulnerabilities have focused regulatory and policy attention on domestic biologic manufacturing capacity, particularly in the EU and US. This creates both regulatory complexity and opportunity.

Conclusion: A Market Built on Regulatory Expertise

Biosimilars are no longer an emerging niche — they are a global healthcare imperative. The market is growing at nearly 20% per year. Patent expiry waves are accelerating. Regulators in every major market are actively evolving their frameworks. And at the heart of every biosimilar programme, without exception, is a team of skilled regulatory affairs professionals who understand the science, navigate the guidelines, and build the strategic submissions that bring these medicines to patients.

If you are considering a career in regulatory affairs, biosimilars represent one of the most dynamic, well-funded, and professionally rewarding areas you can enter. The demand for skilled professionals is real, it is growing, and it is global.

🎓 Ready to Start Your Regulatory Affairs Career?

At Entry to Regulatory, we provide industry-leading training courses for anyone looking to build a career in Regulatory Affairs — whether you're a science graduate, a healthcare professional looking to pivot, or a career changer who wants to break into the life sciences sector.

Unlike purely academic programmes, we offer:

✅ Real-life work assignments — not just theory, but hands-on regulatory tasks that mirror actual industry work

✅ Job support — helping you translate your training into actual employment

✅ Expert mentoring — from active professionals working across pharma, biotech, and medical devices

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The biosimilars sector is hiring. Regulatory professionals are in demand. The question is: will you be ready?

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About the Author: Rabiea is an Honorary Associate Professor at UCL, former MHRA Health Authority reviewer, and CEO of Entry to Regulatory and Advanced Regulatory Consulting. After transitioning from retail pharmacy to regulatory affairs, she has dedicated her career to helping others make the same successful career change. Connect with her on LinkedIn for the latest regulatory affairs insights and career advice.