List of Biosimilars Companies with Phase 4 Active Clinical Trial - 12

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Amgen

Amgen

Thousand Oaks, California, United States of America

Amgen Inc. discovers, develops, manufactures, and delivers human therapeutics worldwide. It focuses on inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience areas. The company’s products include Enbrel to treat plaque psoriasis, rheumatoid arthritis, and psoriatic arthritis; Neulasta that reduces the chance of infection due a low white blood cell count in patients cancer; Prolia to treat postmenopausal women with osteoporosis; Xgeva for skeletal-related events prevention; Otezla for the treatment of adult patients with plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s disease; Aranesp to treat a lower-than-normal number of red blood cells and anemia; KYPROLIS to treat patients with relapsed or refractory multiple myeloma; and Repatha, which reduces the risks of myocardial infarction, stroke, and coronary revascularization. It also markets Nplate, Vectibix, MVASI, Parsabiv, EPOGEN, KANJINTI, BLINCYTO, Aimovig, EVENITY, AMGEVITATM, Sensipar/Mimpara, NEUPOGEN, IMLYGIC, Corlanor, and AVSOLA. Amgen Inc. serves healthcare providers, including physicians or their clinics, dialysis centers, hospitals, and pharmacies. It distributes its products through pharmaceutical wholesale distributors, as well as direct-to-consumer channels. It has collaboration agreements with Novartis Pharma AG; UCB; Bayer HealthCare LLC; BeiGene, Ltd.; Eli Lilly and Company; Datos Health; and Verastem, Inc. to evaluate VS-6766 in combination with lumakrastm (Sotorasib) in patients with KRAS G12C-mutant non-small cell lung cancer. It has an agreement with Kyowa Kirin Co., Ltd. to jointly develop and commercialize KHK4083, a Phase 3-ready anti-OX40 fully human monoclonal antibody for the treatment of atopic dermatitis and other autoimmune diseases; and research and development collaboration with Neumora Therapeutics, Inc. and Plexium, Inc. Amgen Inc. was incorporated in 1980 and is headquartered in Thousand Oaks, California.

Biogen

Biogen

Cambridge, Massachusetts, United States of America

Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

Bio-Thera Solutions

Bio-Thera Solutions

Guangzhou, China

Bio-Thera Solutions is a clinical-stage pharmaceutical company focused on biologic therapeutics. Bio-Thera is developing a pipeline on innovative enhanced monoclonal antibodies and antibody-drug conjugates for the treatment of a broad range of cancers and other diseases as well as a pipeline of biosimilars in the autoimmune and oncology therapeutic areas. The company is headquartered in Guangzhou, China.

Celltrion

Celltrion

Incheon, Republic of Korea

Celltrion is a leading biopharmaceutical company that specializes in research, development and manufacturing of innovative therapeutics. We are committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. We have been at the forefront of biotherapeutic development uncovering new ways of targeting the drivers of disease by creating next-generation biologics and small molecule products. For additional information on our guidelines, please visit: http://tinyurl.com/bdh9bxs9

Coherus BioSciences Inc.

Coherus BioSciences Inc.

Redwood City, California, United States of America

Coherus is a commercial-stage biopharmaceutical company focused on the research, development, and commercialization of innovative immunotherapies to treat cancer and the commercialization of our portfolio of FDA-approved therapeutics. We are building a leading oncology company backed by in-house expertise and an established infrastructure from our diversified portfolio of FDA-approved biosimilar products. If you are interested in joining a highly innovative and exciting company, please visit our careers webpage at http://www.coherus.com/careers/ for a list of career opportunities.

Dong-A Pharmaceutical

Dong-A Pharmaceutical

Seoul, Korea

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.

Kissei Pharmaceutical

Kissei Pharmaceutical

Matsumoto City, Japan

Kissei Pharmaceutical - Approaching R&D with Passion and Creativity “Pharmaceutical company cannot exist without R&D.” These words have been passed down at Kissei ever since the company was founded. They show that R&D is an essential and central part of our work, The phrase also expresses the passion of each and every Kissei Pharmaceutical - Kissei employee for the development of new innovative drugs, in the hope that those drugs will help as many people as possible recover as quickly as possible from disease and live lives full of laughter and joy. We aim to develop and supply innovative pharmaceutical products that contribute to the improvement of medicine and the health of people around the world by aggressive incorporation of leading-edge technology and collaborations with our foreign and domestic partners.

Pfizer

Pfizer

New York, New York, United States of America

Pfizer Inc. discovers, develops, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. It offers medicines and vaccines in various therapeutic areas, including cardiovascular metabolic and women’s health under the Premarin family and Eliquis brands; biologics, small molecules, immunotherapies, and biosimilars under the Ibrance, Xtandi, Sutent, Inlyta, Retacrit, Lorbrena, and Braftovi brands; and sterile injectable and anti-infective medicines, and oral COVID-19 treatment under the Sulperazon, Medrol, Zavicefta, Zithromax, Vfend, Panzyga, and Paxlovid brands. The company also provides medicines and vaccines in various therapeutic areas, such as pneumococcal disease, meningococcal disease, tick-borne encephalitis, and COVID-19 under the Comirnaty/BNT162b2, Nimenrix, FSME/IMMUN-TicoVac, Trumenba, and the Prevnar family brands; biosimilars for chronic immune and inflammatory diseases under the Xeljanz, Enbrel, Inflectra, Eucrisa/Staquis, and Cibinqo brands; and amyloidosis, hemophilia, and endocrine diseases under the Vyndaqel/Vyndamax, BeneFIX, and Genotropin brands. In addition, the company is involved in the contract manufacturing business. It serves wholesalers, retailers, hospitals, clinics, government agencies, pharmacies, and individual provider offices, as well as disease control and prevention centers. The company has collaboration agreements with Bristol-Myers Squibb Company; Astellas Pharma US, Inc.; Myovant Sciences Ltd.; Akcea Therapeutics, Inc; Merck KGaA; Valneva SE; BioNTech SE; and Arvinas, Inc. Pfizer Inc. was founded in 1849 and is headquartered in New York, New York.

Qilu Pharmaceuticals

Qilu Pharmaceuticals

243 Gong Ye Bei Road, Jinan City, Shandong Province 250100, CN

Qilu Pharmaceuticals is a leading Chinese pharmaceutical company founded in 1958, recognized as one of the top three players in China's pharmaceutical industry. The company operates as a vertically integrated enterprise, focusing on human medicines, veterinary medicines, and crop protection products. It has 12 subsidiaries and 11 manufacturing sites across China. Qilu's product portfolio includes over 300 finished dosage forms, making it a prominent manufacturer of injectables and solid-dose medications. The company also produces a wide range of active pharmaceutical ingredients (APIs) and has a robust pipeline with more than 200 generic drugs, 20–30 biosimilars, and 80–90 innovative drugs in development. With a global reach, Qilu exports products to over 100 countries and has established subsidiaries in the U.S., Europe, and Brazil. The company employs over 39,000 people worldwide, with a strong emphasis on affordable medicines and improving global health.

SUN PHARMA

SUN PHARMA

Sun House, CTS No. 201 B/1,, Western Express Highway, Goregaon East, Mumbai, Maharastra 400063, IN

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is a prominent global pharmaceutical company based in India. Established in 1983, it has grown to become the largest pharmaceutical company in India and the fifth-largest specialty generic pharmaceutical company worldwide. Sun Pharma specializes in generic and specialty pharmaceuticals, focusing on chronic therapies in areas such as cardiology, psychiatry, neurology, gastroenterology, and oncology. The company operates in over 100 countries, with significant markets in the U.S., India, and emerging economies. Sun Pharma produces a diverse range of off-patent generic drugs, including tablets, capsules, injectables, and topical formulations. It also develops complex generics and specialty products for various conditions. The company has a strong commitment to research and development, investing in novel drug delivery systems and biosimilars. With 43 manufacturing facilities across five continents and a workforce of over 37,000, Sun Pharma continues to expand its global footprint and enhance its product offerings.

TRPHARM

TRPHARM

Istanbul

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.

Viatris Inc

Viatris Inc

Pittsburgh, Pennsylvania, United States

Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale. In 2022 alone, we supplied high-quality medicines to approximately 1 billion patients around the world. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world’s most enduring health challenges, access takes on deep meaning at Viatris. We have the ability to touch all of life’s moments, from birth to end of life, acute conditions to chronic diseases. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India Social Media Guidelines: https://newsroom.viatris.com/social-media-community-guidelines Investors: https://investor.viatris.com Corporate Social Responsibility: https://www.viatris.com/sustainability Connect with Viatris Instagram: https://www.instagram.com/viatrisinc X: https://www.twitter.com/viatrisinc Viatris and our recruiting firms will not ask for sensitive personal information, such as your social security number, date of birth or bank account details via text, email or social media. Additionally, Viatris representatives do not request payment or personal bank information nor send payment to purchase hardware on your own. Viatris.com is the primary source of all company job postings and authorized third-party career websites.