Columbia Biosimilars Market Research Report, 2030

Colombia is emerging as a key player, thanks to its agile regulatory framework, an active authority such as INVIMA, and policies that promote access to biotechnological medicines. In recent years, Colombia has made significant regulatory advances. INVIMA has implemented measures to streamline biosimilar evaluations while maintaining high technical standards. This environment is favorable for market entry, but it also demands strong technical preparation. In Colombia, the regulatory body for the approval of biologicals is the National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA). INVIMA is the National Regulatory Agency, a technical-scientific surveillance and control entity, which works to protect the individual and collective health of Colombians, through the application of health standards associated with the consumption and use of food, medicines, medical devices and other products subject to health surveillance. The regulatory body for approval of medicines in Colombia is INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia’s National Institute of Food and Drug Monitoring. It is the national regulatory agency, a technical-scientific surveillance and control body, which works to protect the individual and collective health of Colombians, through the application of health standards associated with the consumption and use of food, medicines, medical devices and other products subject to health surveillance. The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Colombia. According to the research report, “Columbia Biosimilars Market Research Report, 2030” published by Actual Market Research, the Columbia Biosimilars market was valued at USD 220 Million in 2025. Colombia's biosimilars industry is steadily advancing, propelled by a combination of regulatory reforms, market dynamics, and strategic investments. A significant driver of this growth is Colombia's progressive regulatory framework. The National Institute for Food and Drug Surveillance (INVIMA) has established three distinct pathways for biosimilar approval: the full dossier approach, the comparability pathway, and the abbreviated comparability approach . These pathways are designed to ensure rigorous evaluation of biosimilars while facilitating their entry into the market, thereby enhancing patient access to affordable biologic therapies. The demand for biosimilars in Colombia is further fueled by the rising prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders. Biosimilars offer cost-effective alternatives to original biologic drugs, making them an attractive option for both healthcare providers and patients. The government's commitment to expanding healthcare coverage and reducing treatment costs has led to increased adoption of biosimilars within the public health system.

What's Inside a Actual Market Research`s industry report?

Asia-Pacific dominates the market and is the largest and fastest-growing market in the animal growth promoters industry globally

Download Sample

Monoclonal antibodies (mAbs) are leading the biosimilars industry in Colombia due to a combination of rising therapeutic demand, market accessibility initiatives, and the clinical importance of these biologics in treating prevalent health conditions. These complex molecules are used in the treatment of various chronic and life-threatening diseases such as cancer, rheumatoid arthritis, and inflammatory bowel diseases—conditions that have seen increasing incidence rates in Colombia over recent years. The high clinical relevance of mAbs and their traditionally high cost as originator biologics have made them prime candidates for biosimilar development and adoption. Colombian healthcare authorities and providers have recognized the potential of biosimilar mAbs to reduce healthcare expenditure while maintaining treatment efficacy, thereby accelerating their integration into public and private healthcare systems. Furthermore, the regulatory framework established by Colombia's National Institute for Food and Drug Surveillance (INVIMA) supports the introduction of biosimilar mAbs through comparability pathways that ensure both safety and cost-efficiency. This regulatory clarity has encouraged pharmaceutical companies to invest in biosimilar development, with monoclonal antibodies emerging as the most commercially viable segment due to their market size and therapeutic range. The growing acceptance of biosimilar mAbs among healthcare professionals—bolstered by successful real-world outcomes and increasing confidence in biosimilar pharmacovigilance systems—has further contributed to their dominance in the Colombian biosimilars landscape. In addition, international partnerships and technology transfers from global biopharma firms have helped local manufacturers strengthen their capabilities in producing high-quality biosimilar mAbs. These collaborations not only reduce production costs but also expand access to biologics across the country. Public hospitals and social health insurance schemes are increasingly prioritizing biosimilars, especially mAbs, to optimize resource allocation while ensuring continued access to critical therapies. Oncology is leading the biosimilars industry in Colombia due to the high prevalence of cancer across the country, the immense cost burden of oncology treatments, and the increasing availability of biosimilar alternatives for expensive biologic drugs used in cancer care. Cancer is a major public health concern in Colombia, with rising incidence and mortality rates driven by aging demographics, lifestyle changes, and limited early detection infrastructure. Biologic drugs, such as monoclonal antibodies used in targeted cancer therapies (e.g., trastuzumab, rituximab, and bevacizumab), are essential components in the modern treatment of various cancers, including breast, lung, and lymphomas. However, their high prices often limit accessibility, especially within Colombia’s public health system. Biosimilars offer a critical solution by delivering clinically equivalent outcomes at a significantly reduced cost, making cancer care more sustainable and accessible. The Colombian government has been actively promoting the use of biosimilars to improve public access to life-saving treatments and reduce the financial strain on the healthcare system. Oncology biosimilars have therefore received significant regulatory attention and policy support. INVIMA has adopted WHO-aligned guidelines that allow for the rigorous but streamlined approval of oncology biosimilars through comparability exercises, facilitating faster market entry. As a result, Colombia has seen the introduction and growing use of biosimilar versions of key oncology biologics, improving treatment penetration in underserved populations. Public procurement policies, particularly those used by Colombia’s national health insurance system (EPS), increasingly prioritize biosimilar adoption to maximize coverage under budgetary constraints. Additionally, oncologists and healthcare institutions in Colombia are becoming more confident in prescribing biosimilars due to accumulating clinical evidence, successful outcomes, and increasing familiarity with biosimilar pharmacovigilance practices. Educational campaigns and partnerships with international biopharmaceutical companies have further reinforced confidence in the quality and efficacy of oncology biosimilars. As a result, the oncology segment not only leads in biosimilar sales but also acts as a catalyst for broader acceptance of biosimilars across other therapeutic categories.

Make this report your own

We're excited to discuss your needs and our solutions. Let's schedule a call.

Ask an Expert

Nikita Jabrela

Business Development Manager

In-house manufacturers are leading the biosimilars industry in Colombia due to their strategic advantages in cost control, regulatory compliance, and responsiveness to local healthcare demands. Colombian pharmaceutical companies that produce biosimilars internally—rather than relying heavily on imports or outsourcing—are better positioned to navigate the country’s regulatory and market environment efficiently. With INVIMA (Colombia’s drug regulatory authority) providing clearer pathways for biosimilar approvals, domestic companies have invested in developing in-house capabilities to manage research, development, and production under one roof. This vertical integration enables faster product development cycles, tighter quality control, and the ability to swiftly adapt to changes in local regulations or healthcare system needs. Another major driver of in-house dominance is the government's focus on pharmaceutical self-sufficiency and cost containment. By encouraging local production of biosimilars, Colombian authorities aim to reduce the country’s dependence on expensive imported biologics and improve access to essential therapies for diseases such as cancer, autoimmune disorders, and anemia. In-house manufacturers are well-aligned with these national healthcare goals, offering competitive pricing without compromising on quality—making their products more appealing to public procurement agencies and health insurance providers. This synergy between domestic manufacturing and public sector priorities has significantly boosted the visibility and market share of locally developed biosimilars. Furthermore, in-house operations allow Colombian pharmaceutical firms to build specialized expertise in biologic production, invest in workforce development, and retain intellectual property within the country. Local companies can also engage in partnerships with research institutions and clinical networks to support trials and post-market surveillance, creating a robust ecosystem for biosimilar innovation. With the growing confidence of healthcare professionals in the safety and efficacy of domestically produced biosimilars, along with national policies that increasingly favor local sourcing, in-house manufacturers have emerged as the dominant force in Colombia’s biosimilars market. Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030 Aspects covered in this report • Biosimilars Market with its value and forecast along with its segments • Various drivers and challenges • On-going trends and developments • Top profiled companies • Strategic recommendation

Don’t pay for what you don’t need. Save 30%

Customise your report by selecting specific countries or regions

Specify Scope Now

By Product • Monoclonal Antibodies • Insulin • Erythropoietin • Others (Includes recombinant glycosylated and non-glycosylated proteins) By Application • Oncology • Chronic & Autoimmune Disorders • Blood Disorders • Growth Hormonal Deficiency • Infectious Disease • Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept) By Manufacturer • In-house • Contract Research and Manufacturing Services The approach of the report: This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases. After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources. Intended audience This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.