In which countries is Casirivimab/Imdevimab approved?

Overview of Casirivimab/Imdevimab
Casirivimab/Imdevimab is a combination of two recombinant human monoclonal antibodies designed to target the severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2). These antibodies bind non‑competitively to distinct, non‑overlapping epitopes on the spike protein’s receptor‑binding domain (RBD). By doing so, they inhibit the spike protein’s ability to attach to the human angiotensin‑converting enzyme 2 (ACE2) receptors, which are essential for the virus to gain entry into host cells. The dual–antibody approach minimizes the chance that viral mutations in the spike protein will render the therapy ineffective, as both components must lose activity before escape occurs.

Mechanism of Action
The molecular activity of Casirivimab and Imdevimab hinges on their ability to neutralize SARS‑CoV‑2. Casirivimab binds to one epitope on the spike protein while Imdevimab targets another, distinct epitope. Their coordinated binding prevents the interaction of the virus with the ACE2 receptor and blocks viral fusion with host cells. In vitro and in vivo studies have shown that this antibody cocktail not only reduces viral load in treated patients but can also elicit an antibody‑mediated cytotoxic response against infected cells. The robust antiviral mechanism has been central to the clinical strategy for COVID‑19 treatment, particularly in patients identified as high‑risk for progression to severe disease.

Clinical Use Cases
Casirivimab/Imdevimab has been chiefly indicated for two principal clinical scenarios. First, for the treatment of mild to moderate COVID‑19, the therapy is recommended in outpatient settings for adults and pediatric patients (aged 12 years and above and weighing at least 40 kg) who test positive for SARS‑CoV‑2 and are at high risk of progressing to severe illness. Early administration in these patients has been shown to result in a significant reduction in viral load, a decrease in the proportion of hospitalizations, and a shortened duration of symptoms compared to placebo. Second, the antibody combination is used in the prophylaxis of COVID‑19, both pre‑exposure and post‑exposure, to prevent symptomatic infection, especially in populations where vaccination may be insufficient or contraindicated. This dual clinical utility—treatment and prevention—has contributed to its widespread discussion in the context of the global COVID‑19 pandemic and has shaped its regulatory pathway around the world.

Regulatory Approval Process
The approval process for biologics such as Casirivimab/Imdevimab is multifaceted, incorporating rigorous evaluations that balance efficacy, safety, and consistency of the manufacturing process. The overall regulatory approach for biologics differs from that of small‑molecule drugs and places a strong emphasis on demonstrating “biosimilarity” or, in the case of innovative medicines, definitive evidence from phase‑dedicated clinical trials and post‑approval surveillance.

General Approval Procedures for Biologics
Biologics are subject to an intensive review process by regulatory agencies worldwide. Typically, the development program for a biologic includes extensive analytical testing, non‑clinical studies (in vitro and in vivo), and multiple clinical phases to evaluate pharmacokinetics (PK), immunogenicity, efficacy, and safety. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and others have established accelerated pathways in pandemics. Under non‑pandemic conditions, the full marketing authorization would require demonstration of clinically meaningful benefits over standard treatments. In emergency circumstances, as witnessed during the COVID‑19 pandemic, regulators may grant Emergency Use Authorizations (EUAs) based on interim data from controlled clinical trials, with the understanding that full approval may be secured upon the completion of further studies and post‑market surveillance. Each jurisdiction has its own set of guidelines that inform the regulatory review process—including dossier submissions, quality control, and inspection of manufacturing facilities—which are then synthesized to approve or deny marketing applications.

Specific Approval Process for Casirivimab/Imdevimab
For Casirivimab/Imdevimab, the urgency of the COVID‑19 pandemic spurred an expedited approval process. In the United States, the FDA granted an Emergency Use Authorization in November 2020 for the treatment of mild to moderate COVID‑19 in high‑risk individuals. This EUA was based on promising results from randomized controlled trials showing significant reductions in viral load and hospitalizations among treatment recipients. In Europe, after a thorough evaluation by the EMA’s Committee for Medicinal Products for Human Use (CHMP), the European Commission granted a full marketing authorization on 12 November 2021 for a product marketed as Ronapreve—which is the trade name for the Casirivimab/Imdevimab combination. In Japan, the pharmaceutical regulatory body (PMDA) approved the therapy in a similar context, validating its safety and efficacy data through local reviews. Overall, the approval processes in different regions reflect a combination of emergency measures and subsequent formal reviews, presenting a model for how biologics can be rapidly deployed in a public health crisis while maintaining robust standards.

Countries with Approval
The global landscape of regulatory approvals for Casirivimab/Imdevimab is varied, reflecting both the urgency of the COVID‑19 emergency and the different criteria for full marketing authorization versus emergency use authorizations. The therapy’s approval status must be understood in the context of both emergency authorizations and permanent marketing approvals as granted by various regulatory agencies.

North America
In North America, the United States has adopted an expedited approach to Casirivimab/Imdevimab due to the exigencies of the pandemic.
– In the United States, although the antibody cocktail has not received a full marketing approval as a conventional therapeutic, it has been granted an Emergency Use Authorization by the FDA since November 2020. This EUA permits its use in non‑hospitalized adults and pediatric patients (≥12 years old and ≥40 kg) who test positive for SARS‑CoV‑2 and are at high risk for severe disease. The EUA framework allows clinicians to administer the therapy based on the best available clinical data while formal evaluation continues.
– Additionally, Canada is mentioned as one of the territories where Casirivimab/Imdevimab is authorized for emergency or temporary pandemic use. Although Canada may not have a full marketing authorization deemed equivalent to that of the European Commission in the EU, Canadian regulatory authorities have extended emergency approvals during the public health emergency, thereby allowing healthcare providers to prescribe the combination under specific conditions.

Europe
Europe presents a contrasting scenario where a full marketing authorization was conferred rather than relying solely on emergency use.
– The European Commission granted marketing authorization for Ronapreve, the branded formulation of Casirivimab/Imdevimab, on 12 November 2021 after a positive opinion from the EMA’s CHMP. This approval covers the treatment of adult and adolescent patients (aged 12 years and older who weigh at least 40 kg) who do not require supplemental oxygen, as well as for the prophylaxis of COVID‑19 in high‑risk individuals. The full marketing authorization in Europe reflects a comprehensive review of phase III clinical trial data, which demonstrated a significant reduction in hospitalizations and a reduction in symptom duration.
– Within the European Union, this approval extends to all member countries, which collectively follow the centralized procedure administered by the EMA. In practice, this means that countries such as Germany, France, Spain, Italy, the Netherlands, and others in the EU have access to Ronapreve under the established marketing authorization.
– Moreover, the United Kingdom, although no longer an EU member, has a regulatory framework that has conditionally approved the use of Casirivimab/Imdevimab through agencies such as the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA’s process has been closely aligned with the EMA’s evaluation, resulting in a conditional approval that serves the public health needs during the pandemic.

Asia and Other Regions
In Asia and other regions outside North America and Europe, the approval status varies from full approvals to conditional and emergency authorizations.
– Japan is one of the countries that has fully approved the use of Casirivimab/Imdevimab. The PMDA in Japan evaluated the clinical trial data and approved the therapy for the treatment of mild to moderate COVID‑19, thereby reflecting its confidence in the safety and efficacy profile of the antibody cocktail. Such regulatory rigor is particularly important in Asia, where local populations are evaluated through bridging studies and other localized data assessments.
– The United Kingdom and Australia have received conditional approvals for Casirivimab/Imdevimab. In these regions, the regulatory authorities have given the green light on the basis of strong clinical evidence, although further data might be required to transition from a conditional approval status to full marketing authorization. This conditional status helps initiate widespread use while additional post‑approval studies are conducted.
– India, while not featured in a traditional marketing authorization framework comparable to the EU, is another key region. In India, partnerships such as the one between Cipla and Roche have been established to market Casirivimab/Imdevimab for COVID‑19 treatment. This partnership ensures that the therapy is available under relevant emergency use protocols or provisional approvals, making it accessible to patients in a country with a high burden of COVID‑19.
– Beyond these, the antibody cocktail has been made available in several other countries through bilateral purchase agreements and emergency use provisions. According to recent reports, Ronapreve is currently available in nearly 50 countries globally, including several lower‑middle‑income countries. Although the specific regulatory status (full marketing approval versus emergency authorization) may differ from one nation to another, Casirivimab/Imdevimab is broadly recognized as an important therapeutic agent in the COVID‑19 response.
– Some regions in the Middle East and Southeast Asia have also received emergency use authorizations or conditional approvals. These authorizations ensure that even in jurisdictions with limited full‑approval infrastructure, the therapeutic benefits of the antibody cocktail can be utilized during the ongoing pandemic.

Impact and Implications
The approval and subsequent use of Casirivimab/Imdevimab across different regions of the globe have notable implications for both public health and the market landscape of COVID‑19 therapeutics.

Public Health Impact
On the public health front, the diverse regulatory approvals play a crucial role in combating COVID‑19.
– In regions where full marketing authorization has been granted (notably in the European Union and Japan), healthcare providers have a clearly defined treatment option supported by in‑depth clinical data. The approval of Ronapreve in Europe, for instance, validates its use not only as a treatment for mild to moderate cases but also as a prophylactic measure for high‑risk individuals. This has far‑reaching consequences in reducing hospitalization rates and alleviating the burden on healthcare systems.
– In North America, the emergency use authorization in the United States has facilitated early access to the therapy, particularly during epidemic surges. By enabling early treatment and reducing progression to severe disease, the EUA framework for Casirivimab/Imdevimab has helped to mitigate some of the severe outcomes of COVID‑19.
– The conditional and emergency approvals in other regions such as the United Kingdom, Australia, and India ensure that even in the absence of a full marketing approval, high‑risk patient populations receive timely therapeutic interventions. This agile response is vital during a rapidly evolving pandemic when delays in treatment approval can cost lives.
– Furthermore, the global deployment of Casirivimab/Imdevimab—from high‑income regions to lower‑middle‑income countries—demonstrates an unprecedented level of international cooperation, ensuring that advanced therapies are not confined to select markets. This widespread availability contributes to the overall global effort to reduce transmission, hospitalizations, and mortality related to COVID‑19.

Market Implications
From a market perspective, the regulatory approvals of Casirivimab/Imdevimab have multifaceted implications.
– The full marketing authorization in the European Union has established a solid, predictable market framework for Ronapreve, encouraging manufacturing scalability and stable supply across member states. This authorization, backed by detailed clinical evidence, has instilled confidence in healthcare providers and payors alike, thus fostering higher uptake rates.
– In North America, the EUA in the United States has allowed rapid market entry. Although not a full approval, the EUA has driven substantial utilization, and companies such as Regeneron and Roche have collaborated to expand global distribution networks. This, alongside emergency authorizations in Canada, has set a precedent for balancing emergency needs with regulatory oversight.
– In Asia and other regions, conditional approvals and local partnerships (e.g., in Japan and India) highlight the flexibility of regulatory frameworks during a health crisis. By collaborating with local firms and adapting approval strategies to meet regional needs, global pharmaceutical companies have been able to penetrate diverse markets. This adaptability not only enhances market share but also ensures that advanced therapeutics reach populations that might otherwise have limited access.
– The wide geographical dissemination of Casirivimab/Imdevimab has market implications beyond the immediate treatment needs of COVID‑19. It has stimulated competition in the monoclonal antibody space and spurred further investment in rapid drug development and emergency regulatory pathways. As nearly 50 countries now have access to this therapy—whether through full marketing approvals or emergency use authorizations—the pharmaceutical market is witnessing a new model of global drug accessibility that could reshape future regulatory strategies.

Conclusion
In summary, Casirivimab/Imdevimab is approved or authorized for use in a diverse array of regions worldwide. In North America, it is available under Emergency Use Authorization in the United States and via emergency or temporary pandemic authorizations in Canada. In Europe, the European Commission has granted a full marketing authorization for Ronapreve, ensuring access throughout all EU member states. In Asia, Japan has fully approved the therapy through its PMDA, while the United Kingdom and Australia have issued conditional approvals; in addition, India benefits from robust local partnerships ensuring the availability of the drug under emergency use provisions.

This regulatory mosaic highlights the dual strategies—a rapid response through emergency authorizations and a more definitive review leading to full marketing approvals—that have been employed globally in response to the COVID‑19 crisis. The widespread approval and use of Casirivimab/Imdevimab underscore its significant public health impact by reducing viral load, mitigating hospitalization rates, and serving as an effective prophylactic measure. Market implications include enhanced global supply networks and a new model for rapid therapeutic deployment in pandemic settings. Overall, such regulatory successes illustrate the potential of collaborative international efforts to ensure that innovative therapeutics are made available promptly and effectively, ultimately contributing to a more resilient global health system.