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26/12/2023 2023 Year in Review: Samsung Bioepis’ Advancements in Innovating Healthcare Access
As 2023 comes to a close,  we’re taking this time to reflect on our work and accomplishments throughout the year and the advancing role of biosimilars within global healthcare systems. The global biosimilars market, valued at USD 29.4 billion in 2023, is poised to more than double to USD 66.9 billion by 2028, showing remarkable growth driven by constant product innovation and increasing endorsements from regulatory bodies. Amidst this environment, we have consistently been advancing healthcare access for patients through new product launches, regulatory approvals and strategic initiatives. Let's look back at the progress we have made this year.

Approvals & Market Launches
In July, we launched our adalimumab biosimilar in the United States, in collaboration with our partner Organon. Following the launch, the FDA accepted for review the sBLA for interchangeability designation in November. The launch and interchangeability designation signified major steps in expanding treatment options for millions of patients suffering from chronic autoimmune diseases in the country.
Samsung Bioepis offers both low and high-concentration formulations of adalimumab in the US, aligning with our vision to increase patient accessibility by offering lower cost yet equally effective alternative therapeutic options. Elsewhere, our eculizumab biosimilar — Samsung Bioepis’ first biosimilar in hematology — received the European Commission’s approval in May for the treatment of adults and children with paroxysmal nocturnal hemoglobinuria (PNH)Eculizumab was launched in Germany in July, and in Italy and Spain in September, representing the first biosimilar to be solely commercialized by Samsung Bioepis in Europe. These developments further expand the scope of affordable access to treatment options for patients, contributing to the sustainability of healthcare systems. 

Progress in R&D
Samsung Bioepis has actively continued to present clinical findings at global biosimilar conferences such as the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, the European Hematology Association (EHA) Congress, the European Society of Retina Specialists (EURETINA) Congress, the European Academy of Dermatology and Venerology (EADV) Congress, and more. 
In April, at the ARVO Annual Meeting, we presented the 1-year outcomes of the Phase 3 study for an aflibercept biosimilar. As biosimilars are not widely used in the field of ophthalmology, our presentations showcased our industry-leading research capacity and commitment to foster awareness of biosimilars among medical practitioners across diverse healthcare fields.At the EADV Congress, we also shared Phase 3 data of our ustekinumab biosimilar and 4-year follow-up data on the effectiveness and safety of our adalimumab biosimilar in patients with psoriasis, which found that it can be safely started or transitioned from the reference medicine. With rich data on the clinical effectiveness of biosimilars for various healthcare conditions, we demonstrated our commitment to making physicians and patients confident about the use of biosimilars in real world settings.

Ongoing Initiatives towards a Sustainable Future
This year, we made progress toward building more sustainable and socially responsible practices in supply chain management, manufacturing, research and development (R&D) and clinical trials
Together with Samsung Biologics, Samsung Bioepis is committed to joining the RE100 initiative, pledging to shift to 100% renewable energy and reach net-zero emissions by 2050. Our efforts include increasing the proportion of seaborne shipping, from 9% in 2021 to 22% in 2022, slated to further increase to 50% in 2025. We have also made progress in cutting down on our use of packaging materials. Our etanercept biosimilar now comes with an integrated leaflet, reducing paper consumption by nearly 35-55%. 
These initiatives work to progress towards a sustainable healthcare system. Our biosimilars themselves also help these systems reduce the cost of medications, allowing them to reinvest the savings in other vital initiatives. 

The focus then turns to the three groups who are the main beneficiaries from the increased use of biosimilars: payers, physicians, and patients. In the United States, PBMs, or pharmacy benefit managers, are an additional factor in the equation, functioning as intermediaries between insurance providers and pharmaceutical manufacturers. 
Lastly, the series explains what measures Samsung Bioepis goes through to maintain its quality assurance. By analyzing an extensive number of reference products, conducting advanced analytic methods, and implementing tight quality control, the company ensures that its biosimilars provide the same clinical benefits as reference products—but at a more affordable cost.

Awards and Recognitions
Samsung Bioepis was again recognized for its leadership in biosimilars at the Global Generics & Biosimilars Awards 2023, affirming our long-standing commitment to innovating access to treatments for patients around the world. This year, we were nominated for five categories and won two awards: ‘Company of the Year, Asia-Pacific,’ and ‘Regulatory Achievement of the Year.’ 
Additionally, we earned two ISO Certifications this year: ISO 27001 and ISO 45001, recognizing our work in upholding a healthy and safe workplace environment and quality information security standards. 
Looking ahead, Samsung Bioepis remains dedicated to extending high-quality biosimilar medicines worldwide, driven by our unwavering passion for innovating access. As we enter 2024, we’ll maintain this momentum by pioneering innovative solutions, providing safe and effective medicines and delivering top-quality pharmaceuticals to patients.

.Biosimilars Market Size, Share, Trends and Revenue Forecast [Latest] (marketsandmarkets.com)
.Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA™ (adalimumab-bwwd) in Multiple Presentations Consistent with Originator
.Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a Biosimilar to Humira®
.Samsung Bioepis Presents Population Pharmacokinetic (PK), Pharmacodynamic (PD), Efficacy Modeling of SB12 (Eculizumab), A Biosimilar to Soliris, at the European Hematology Association (EHA) Congress
.1-Year Outcomes of Phase 3 Study for SB15, Proposed Biosimilar to Eylea (aflibercept), Presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
.Samsung Bioepis Presents Population Pharmacokinetic (PK), Pharmacodynamic (PD), Efficacy Modeling of SB12 (Eculizumab), A Biosimilar to Soliris, at the European Hematology Association (EHA) Congress
.Samsung Bioepis Presents Post-hoc Analysis of Phase 3 Clinical Trial for SB15, a Proposed Biosimilar to Eylea (Aflibercept), at EURETINA 2023
.Samsung Bioepis Presents Two Abstracts at EADV 2023 Congress, Highlighting Continuous Dedication in Dermatology
.Sustainability Report 2023 (eng).pdf (samsungbioepis.com)
.Samsung Bioepis Wins Two Categories at the Global Generics & Biosimilars Awards 2023

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