List of Biosimilars Companies with Phase 3 Active Clinical Trial - 23

Partner of choice in specialty, hospital, and rare disease medicines ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients' lives by providing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA's product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.

Our mission is to improve patient lives and the sustainability of the global healthcare ecosystem by broadening the availability and accessibility of biosimilars.

BIOCAD is Russia's leading innovative biotechnology company; it combines a world-class research and development center, ultra-modern pharmaceutical and biotechnological manufacturing facilities, as well as preclinical and clinical research infrastructure compliant with international standards. BIOCAD is one of the world`s few full-cycle drug development and manufacturing companies, from new molecule discovery and genetic engineering to large-scale commercial production and marketing support. BIOCAD`s medicines are dedicated to treat complex health conditions such as cancer, HIV and Hepatitis C infections, multiple sclerosis and other disorders.

Biocon: Enhancing Global Healthcare Biocon Limited, publicly listed in 2004, is India's largest and fully-integrated, innovation-led biopharmaceutical company. It is an emerging global biopharmaceutical enterprise serving customers in over 120 countries. Driven by a vision to enhance global healthcare through innovative and affordable biopharmaceuticals, we have enabled access to advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high. The early anticipation of the increasing dominance of biologics in global development pipelines helped us to be ahead of the curve in crafting a differentiated product portfolio based on fermentation and recombinant technologies, which straddles fermentation-derived small molecules and biologics, both novel as well as biosimilars. The significant brand equity that we have built worldwide for our small molecule APIs across statins, immunosuppresants and other specialty products has made us a leading global supplier of these products. We have also built one of the largest and most diverse biosimilar pipelines, spanning insulins, monoclonal antibodies and other recombinant proteins that address critical chronic diseases such as diabetes, cancer and autoimmune disorders. Ranked among the Top 3 biosimilar players globally for rh-insulin and insulin glargine in volume terms, we are the first Indian company to launch a biosimilar in Japan with Insulin Glargine, which also has been approved for sale in EU and Australia. Our insulin products have made a difference to the lives of millions of people with diabetes across the globe. We now aim to provide our insulin products to ‘one in five’ people with diabetes in need of insulin-based therapy anywhere in the world within the next 10 years. We are also making a huge impact in the area of cancer care. Our biosimilar Trastuzumab, which was the first to be approved anywhere in the world and launched in India in 2014, has helped treat several thousand HER2-positive metastatic breast cancer patients. We are also the first company from India to get its biosimilar approved by the USFDA; Ogivri™, co-developed by Biocon and Mylan, is the first biosimilar Trastuzumab to be approved in the US. In addition to Trastuzumab, several of our biosimilar assets are on track for anticipated regulatory approvals in developed markets. We are also developing a pipeline of patented biologics to address global unmet medical needs. We have successfully launched a couple of novel biologics in India: Nimotuzumab for the treatment of head and neck cancer and Itolizumab to tackle psoriasis. Besides these, we have a basket of novel assets are under various stages of clinical development, including a high potential oral insulin. Through our subsidiary, Syngene, we offer a suite of integrated, end-to-end discovery and development services for novel molecular entities (NMEs) to the global life sciences sector. Ranked by the prestigious Science magazine among the Top 10 Best employers in the biotech industry, Biocon is passionately pursuing a mission to rationalize healthcare spends, enhance access to life-saving therapies and make a significant impact to global healthcare through ‘blockbuster’ drugs with the potential to benefit a billion patients.

CinnaGen is an Iranian biotechnology company founded in 1994 and headquartered in Tehran. It is recognized as a leading biopharmaceutical manufacturer and exporter in the Middle East and North Africa (MENA) region. The company adheres to modern quality standards and complies with Good Manufacturing Practice (GMP) regulations for food and pharmaceutical products. CinnaGen offers contract development and manufacturing services, supporting the development of biopharmaceutical products. The company specializes in biosimilars, particularly for immunological diseases, infertility, hormone disorders, and oncology. Notable products include Cinnovex, a biosimilar for multiple sclerosis, as well as therapeutic recombinant proteins, molecular diagnostic kits, and synthetic peptides. CinnaGen's products are exported to various countries, aiming to enhance patient outcomes in the healthcare sector. The company has achieved significant milestones, including being the first in the MENA region to manufacture Taq DNA polymerase and monoclonal antibodies, and it has received GMP certification from the European Medicines Agency for its biologic plant.

Dong-A ST is a company established in March 2013 following the restructuring of the former Dong-A Pharmaceutical into a holding company. Our company focuses on the development and sale of specialized pharmaceuticals (ETC) and is dedicated to the philosophy of "Our company's social contribution is in new drug development." With state-of-the-art research facilities such as the Yongin Research Center established in 1977 and the completion of the Songdo Research Center in 2021, Dong-A ST has been striving for innovative global new drug development with excellent research and development capabilities. For many years, by consistently investing more than 10% of its revenue in R&D, we have successfully developed multiple proprietary novel drugs, including Stillen, Zydena, Motilitone, Sivextro, and Suganon/Sugamet.

Founded in 1998, Gan & Lee Pharmaceuticals has successfully developed the first Chinese domestic insulin analog. The company has become one of the main suppliers of insulin in China and now strives to broaden its global coverage in the field of diabetes diagnosis and treatment. Headquartered in the Tongzhou Economic Development Area, Beijing, China, Gan & Lee has state-of-the-art buildings and GMP facilities. In 2014, it established a US subsidiary in New Jersey, and in 2019, Gan & Lee selected Linyi City, Shandong, China, to become its second domestic drug production site, with further plans to expand to North America, Europe, and other regions. Gan & Lee is committed to providing solutions to patients across the globe and providing a positive impact on patient lives. Our clinical development program is investigating new chemical entities and biologics to treat cardiovascular disease, metabolic disease, cancer and diseases in other therapeutic areas.

Founded in 2007, Genor Biopharma Co. Ltd (Genor BioPharma, Stock code: 6998.HK) is an innovation-driven biopharma company with a pipeline of therapies covering the world's top oncology areas (breast, lung, and gastrointestinal cancer).

GEROPHARM is one of the 20 leading Russian manufacturers of pharmaceutical preparations. The company has modern industrial sites, where production is carried out on the principle of Full-Cycle: from production of active pharmaceutical ingredients to a market release of the finished product. In addition to the drug production, the company conducts independent studies, annually makes considerable investment in R&D.

ISU ABXIS is continuously striving to provide better treatment options for patients suffering from difficult-to-treat diseases based on Isu’s excellence in biotechnology.

JCR Pharmaceutical is a global specialty pharmaceuticals company that is expanding possibilities for people with rare and genetic diseases worldwide. Our core values – reliability, confidence, and belief – mean that the work we do benefits all our stakeholders, including employees, partners, and patients. We continue to build upon our 49-year legacy in Japan while expanding our global footprint with trials in the US, Europe, and Latin America. We improve patients' lives by applying our scientific expertise and unique technologies to research, develop, and deliver next-generation therapies. We are leaders in developing therapies for rare conditions, including lysosomal storage disorders (LSDs). We are building on the development work we've done in Japan to expand our LSD pipeline: Our first-in-class proprietary technology, J-Brain Cargo®, enables us to develop therapies that cross the blood-brain barrier and penetrate the central nervous system (CNS). The CNS complications of diseases are often severe, resulting in developmental delays, an impact on cognition and, above all, poor prognosis, which affect patients' independence as well as the quality of life of patients and their caregivers. With J-Brain Cargo®, we seek to address the unresolved clinical challenges of LSDs and CNS-related disorders, including neurodegeneration, neuro-oncology, and neuro-inflammation conditions, by delivering the therapy to both the body and the brain. We will continuously try to create value by our unique J-Brain Cargo® technology platform toward our corporate philosophy: “contributing towards people’s healthcare through pharmaceutical products.” In addition to the in-house research activities, we think collaborative research and development work with other companies are also important. The value of our technology platform will be increased by integrating ours with other technologies and by implementing J-Brain Cargo® within other companies’ products.

科兴制药是一家主要从事重组蛋白药物和微生态制剂的研发、生产、销售一体化的创新型生物制药企业，专注于抗病毒、血液、肿瘤与免疫、退行性疾病等治疗领域的药物研发，并围绕上述治疗领域拥有一定中药及化学药技术沉淀。 科兴制药主要产品包括重组蛋白药物"重组人促红素"、"重组人干扰素α1b"、"重组人粒细胞刺激因子"，微生态制剂药物"酪酸梭菌二联活菌"。公司主要产品已沉淀一定行业优势地位和市场影响力，近年来依托政策支持和营销渠道深耕，保持稳定增长。

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

mAbxience is a high growth international biotechnology company specialized in the research, development, manufacture and global commercialization of biopharmaceutical products to treat and prevent diseases across different therapeutic areas.

Mesoblast (ASX:MSB; Nasdaq:MESO) is developing and commercializing allogeneic cellular medicines to treat serious and life-threatening inflammatory diseases with significant, unmet medical needs. The Company's Phase 3 off-the-shelf mesenchymal lineage cell product candidates are: • RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GVHD) • Remestemcel-L for moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection • REVASCOR® for advanced chronic heart failure, and • MPC-06-ID for chronic low back pain due to degenerative disc disease. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast’s approach to product development is to ensure rigorous scientific investigations are performed with well-characterized cell populations in order to understand mechanisms of action for each potential indication. Extensive preclinical translational studies guide clinical trials that are structured to meet stringent safety and efficacy criteria set by international regulatory agencies. All trials are conducted under the continuing review of independent Data Safety Monitoring Boards comprised of independent medical experts and statisticians. Mesoblast has an extensive patent portfolio comprising approximately 1,000 patents and patent applications with protection extending through 2040 in all major markets. This intellectual property portfolio covers composition of matter, manufacturing, and therapeutic applications of mesenchymal lineage cells. The Company believes this patent estate provides strong global protection.

Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe and debilitating disease areas. Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. We encourage our people to think differently and our inclusive culture of continuous learning and collaboration make Mundipharma a great place to work. For more information visit www.mundipharma.com See our community guidelines: mundipharma.com/social-media-community-guidelines

Develop and market generic and biosimilar drugs. Locations throughout the world.

Organon is a global healthcare company with a portfolio of therapies and products in women’s health, biosimilars, and established medicines across a wide array of conditions and diseases. Our mission is to deliver impactful medicines and solutions for a healthier every day. This site is intended for residents of the United States and its territories. You are reminded to protect yourself against recruiting fraud from individuals, organizations or other entities claiming to represent Organon. All official Organon recruitment emails will come from accounts formatted as name@organon.com or organon@workday.com, and Organon will never conduct interviews by chat or email, or make job offers through social media or online forums. All candidates for roles at Organon will first meet with a recruiter and interview team, via Teams or in person. Organon will never ask you to make financial transactions on its behalf or ask you to receive or ship packages or goods. For more information on adverse event reporting, visit http://bit.ly/AEReporting. To read our community guidelines, visit http://bit.ly/OrganonCommunityGuidelines. Follow us on Twitter at Organon (@OrganonLLC). Follow us on Instagram at Organon (@OrganonLLC).

Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop ONS-5010 / LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. Outlook Therapeutics expects to file ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, endocrinology, hematology and nephrology. For more information, please visit: www.samsungbioepis.com. To see our community guidelines, please visit: bit.ly/2l0yiI3

Sandoz is the global leader in generic and biosimilar medicines. ​ ​Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.​ We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.

Shanghai Henlius Biotech isabiopharmaceutical company in China that is developing biologics foroncology and autoimmune diseases.

TRPHARM’s journey, which started in Turkey in 2013, continues with offices in Istanbul and Dubai. Currently, we deliver our products and services to approximately 20 countries, and we maintain our physical presence in 12 of these countries. We are growing rapidly with more than 100 employees who are competent in their fields. We combine our innovative business approaches with medical experience, with the experience of more than a hundred years of experience of the doctors and pharmacists in our team. Our journey that started with medicine continues with the inclusion of non-pharmaceutical health solutions. With our partners in various countries, we provide a wide range of services covering all areas from diagnosis to treatment. Our cooperation philosophy is based on transparency and coexistence within the framework of common goals, guided by our expertise. As TRPHARM, our mission that we have been loyal to since the first day is to bring together innovative solutions with health. Our vision, which we have created with our years of experience, is to be a global, innovative healthcare company. The values that we take as a guide in each of our steps are; LIFE We put people and nature at the heart of our relations with our colleagues, physicians, patients and all other stakeholders and aspire to build a sustainable ecosystem. COLLABORATION In all our actions and business activities, we put harmony, unity and efficiency at the center of our interactions and projects, both within our teams and with our stakeholders. BALANCE In all areas that we add value, we draw on broad vision and harmony of opposite poles/perspectives, and we observe balance and attentiveness in our actions. TRANSFORMATION We adapt to ever-changing conditions that life imposes on us all with resilience and courage. We foresee transformation and changes in needs, respond with agility and grasp new opportunities to achieve our leadership goal.