List of Biosimilars Companies in United States - 35

Abeomics Inc. is founded by scientists for the scientists. Our immunologists, cell biologists and business professionals have contributed for over 25 years to the growth and success of global companies including BD Biosciences, eBioscience and IMGENEX Corporation. We bring our experiences to develop well-validated and specific antibodies by traditional hybridoma technology and by genetic engineering to produce recombinant mouse and rabbit monoclonal antibodies.

Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around the world. We are passionate about making people's lives better by making high quality medicines more accessible around the world. The company has commercial operations in 35 countries with 2,800 employees and operates four manufacturing and development hubs in the U.S., Romania, Korea and Taiwan. North America is Alvogen's single largest market and other key markets include: South Korea, Russia, Taiwan, Romania, Hungary, Ukraine, Japan and China.

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.

Antigen Targeting & Consulting Service Incorporated (ATCS Inc), a biotech company formed in 2009, is dedicated in providing top-quality custom services for the development of vaccines and immunotherapies. The company specializes in targeting antigens to cell surface molecules on dendritic cells for vaccine development, as well as the development of PSMA-targeted PET imaging agents for improved diagnosis of prostate cancer. ATCS Inc also focuses on the translation of multi-antigen targeted off-the-shelf therapies for various medical conditions.

BioFactura develops and commercializes biodefense drugs, novel drugs, and high-value biosimilars (i.e., follow-on biologics or generic biopharmaceuticals) using its patented StableFast™ Biomanufacturing Platform, the optimal choice for bringing these products to market with faster, lower cost, superior-quality manufacture. For over 10 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative drug development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox and Ebola, novel medicines for cancer, and low-cost/high-quality biosimilars for autoimmune and infectious diseases.

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.

ABOUT Biologics Consulting is a complete FDA regulatory and product development consulting firm for cell & gene therapy, biologics, pharmaceuticals, and medical devices. In the three decades since its founding, Biologics Consulting has become the go-to consulting partner for companies large and small seeking to bring innovative, safe, and effective products to market in the US. Our team of regulatory scientists, FDA consultants, and professional services staff has decades of industry and FDA experience that allows us to provide an unparalleled insider perspective for our clients. OUR DIFFERENCE The Biologics Consulting difference is all about the unique combination of regulatory expertise we have under one roof. Our team has depth of knowledge and breadth of experience across all product types and development pathways. This value proposition allows us to address the full scope of a client's regulatory and product development challenges from preapproval to commercialization. OUR EXPERIENCE AREAS - Biologics - Medical Devices - Pharmaceuticals - Biosimilars OUR SERVICES - CONSULTING – Regulatory, Product Development, Clinical Planning and Quality support. - SUPPORT SERVICES – Medical Writing, e-Publishing & Submissions, US Agent Services, Due Diligence OUR CLIENTS Our clients span the industry, from established multi-national pharmaceutical, biotechnology, and medical device companies to academic and research institutions. We also support small biotech and medical device start-ups. Since our founding, we have professionally services over 4,500 clients from 58 different countries.

BioQ Pharma is a specialty pharmaceutical company that focuses on setting a new standard of care for infusible drugs.

BioQ Pharma is a late stage specialty pharmaceutical company focused on developing.

Our company is uniquely positioned with a multi-facetted experience team in biologics and biosimilars. BioSciencesCorp and its affiliates have the speed of small company with a depth of biologics experience from molecule selection to full commercialization.

Bold and nimble, Boston Oncology is an innovative biogenerics company redefining excellence in the licensing and local development, manufacturing and distribution of US- quality medicines – across therapeutic areas. From our nerve center in Riyadh, we leverage the expertise, daring creativity, and unwavering determination of our international leadership team to provide customers with end-to-end, efficient, single-point-of-contact access to our diverse portfolio of world-class biogenerics. We do this because lives depend on it.

Civica Rx was created in late 2018 to secure the supply of important medicines hospitals use every day. As of Q2 2024, we have provided over 180 million units of essential medicines to hospitals, enough to help treat over 80 million patients. Recently, we announced we will manufacture and distribute affordable medications for consumers in an outpatient/retail setting, including affordable insulin. Insulin is an exciting project as we are partnering with nearly every corner of the diabetes ecosystem to bring low-cost insulin to people living with diabetes at no more than $30 a vial and no more than $55 for a pack of five pre-filled pens, regardless of insurance status. WHY CIVICA? Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company our mission is to ensure quality generic medicines are accessible and affordable to everyone.

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.

CONTRACT PHARMA is the multi media information outlet dedicated to bio/pharma outsourcing. From drug development to manufacturing, we cover the latest developments, views and opinions from industry leaders in print and online. CONTRACT PHARMA offers advertising opportunities in our print magazine, Contract Pharma Direct weekly e newsletter and on contractpharma.com. We are the only worldwide print publication focused on Bio/Pharma contract services, delivering a total qualified circulation of 20,013. (VAC audit statement) On Sept. 26-27, 2024 CONTRACT PHARMA will host its 23rd Annual Contracting & Outsourcing Conference & Tabletop Exhibition. This event brings together speakers from the FDA, industry leaders, and expert analysts to discuss issues critical to success for Pharma & Biopharma outsourcing. The one-day Tabletop Exhibition of 160 top contract service providers provides great exposure to outsourcing decision makers. CONTRACT PHARMA's Corporate Capabilities and Contract Services Directory is the largest single source for company profiles and contract services. This standalone print issue showcases the services of Bio/Pharma contract service providers. The Contract Services Directory is also available online at www.contractpharma.com/csd. It's an indispensable guide for contract services in print and online. Every week, thousands of Bio/Pharma outsourcing professionals go to www.contractpharma.com to read current features, find archive stories, and get breaking news and online exclusives. We also e-mail CONTRACT PHARMA DIRECT, our weekly e-newsletter, to more than 20,000 people. CPDirect is filled with the latest news, our most recent articles, and links to our popular annual features and upcoming meetings. Free subscriptions are available on our website. Contact us for more information on how your company can get involved with Contract Pharma.

Dr. Reddy's Laboratories is a pharmaceutical company that specializes in pharmaceutical manufacturing and healthcare products.

GenNext Technologies makes structural biology easy by providing instrumentation, software, and services to pharmaceutical researchers investigating biopharmaceutical structure, interactions, folding, aggregation, formulation, and delivery. Our disruptive products are aimed at improving structural biology-focused research. Ultimately, we help our customers accelerate biopharmaceutical development, while improving therapeutic efficacy and safety.

Ice Bear Therapeutics SPC is a social purpose company based in Seattle, WA, founded 2021, with the mission of bringing affordable insulin to patients with type 1 or type 2 diabetes.

Just – Evotec Biologics, wholly owned by Evotec SE, is a first-to-industry biologics platform that leverages AI/ML technologies and world-leading molecular design, cell line development, process intensification and continuous manufacturing strategies to advance biotherapeutics from discovery through clinical stages to commercial launch. The Just – Evotec Biologics team combines deep industry experience in the fields of data, protein, process, and manufacturing sciences including automation with highly integrated and flexible capabilities to break through the scientific and economic barriers associated with the development of protein therapeutics. Our focus is to accelerate and expand access to biotherapeutics through scientific and technological innovation for our proprietary projects and on behalf of our partners.

Kashiv BioSciences manufactures drug delivery systems and specialty drug products for the treatment of debilitating diseases.

For scientists in life sciences discovery, and biopharmaceutical and diagnostics segments utilizing antibodies, biologically active proteins, and assays, reproducible science is the key to unlocking the scientific doors. Leinco Technologies Inc. adheres to ISO 9001:2015 and ISO 13485:2016 quality standards, and provides access to antibodies and proteins used in a broad range of life sciences applications uncovering interactions in cancer, infectious diseases and immunology. Our proprietary techniques result in the highest purity antibodies (monoclonal, recombinant and polyclonal) and proteins enabling scientists globally to generate reproducible science and faster time to scientific results across a broad range of cell, tissue and in vivo applications (e.g. spatial biology, flow cytometry, pre-clinical in vivo and in vitro studies). For our many partners, the Leinco scientists with over 30 years’ experience take a consultative approach and are committed to delivering the highest quality CDMO services (e.g. antibody scale-up and purification, optimized conjugation to reporter molecules and assay development/manufacturing) that save time and ensure our customers are successful in their programs.

Founded in 2017, Meitheal Pharmaceuticals is a privately owned pharmaceutical company focusing on generic injectable products. Headquartered near Chicago, Illinois, Meitheal has an established management team and an aggressive growth strategy. Through global partnerships, our goal is to bring supply to US healthcare providers that demand a reliable, high quality, yet affordable supply of injectables.

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.

Catalent Inc. (NYSE: CTLT), an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent supports our partners in introducing 200 new products and manufacturing over 70 billion doses each year. Since becoming a publicly traded company in 2014, we have grown to become a community of approximately 19,000+ workers who support over 7,000 products for over 1,000 customers around the world. We share a common goal: to put patients first and help people around the world live better and healthier lives. Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. We have the deepest expertise, the broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging results. more products. better treatments. reliably supplied.™ Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us! Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech, and healthcare companies, will help bring life-enhancing products to life. Grow with us. Be challenged. Make a personal impact. Visit https://careers.catalent.com/us/en to explore career opportunities

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.

Rani Therapeutics is a clinical-stage biotech company that has developed a platform technology to enable oral delivery of biologic drugs. Millions of patients with chronic conditions require biologic drugs, the vast majority of which must be injected. We have developed the RaniPill™ technology to replace subcutaneous or IV injections of biologics with an oral pill. The RaniPill™ capsule is designed to deliver an injection to the intestinal wall, where there are no sharp pain receptors, and has achieved bioavailability similar to subcutaneous injections. We believe oral versions of biologics will have the potential to transform medicine and improve outcomes for the millions of patients who currently rely on chronic self-injections.

rBIO is a Biotechnology company that excels in Synthetic Biology and genetic engineering to optimize protein synthesis.

SarcoMed USA was formed in Texas in 2017 to determine if Pulmozyme could improve Pulmonary Sarcoidosis. The company is nearing a final license for the treatment of pulmonary sarcoidosis and related respiratory diseases via inhaled delivery.

Score Pharma is developing new, more potent antibody therapeutics by transforming existing clinically proven antibody therapeutics for an improved patient response. Our team is prioritizing cancer therapies such as non-Hodgkin lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), and HER2-positive breast cancer. By enhancing existing technologies with a patent-pending improvement process, we expect better therapies with a higher probability of clinical and regulatory success.

Syd Labs, a recombinant company based in Boston, Massachusetts, is dedicated to providing quality products and services for research and development in academy, industry, and government. We have always tried our best to let you, our valuable customers and partners, save money and work better. Syd Labs, Inc provides very comprehensive and competitive services for antibody services, from peptide synthesis, gene synthesis, protein expression, rabbit and mouse polyclonal antibody development, mouse, rat, and rabbit monoclonal antibody development, cloning variable regions of hybridoma cell lines, antibody humanization and engineering, stable cell line generation, ELISA assay development, and so on. The lowest prices are guaranteed. If you find any US company providing the same quality services with lower prices, we will return the difference to you.

Trophogen, Inc. is a biotechnology company founded in 2001 with series A funding from Toucan Capital, focusing on the development of high affinity glycoprotein hormone and related growth factor analogs for human and animal infertility as well as targeted therapy and imaging of thyroid, ovarian, breast, prostate and testicular cancers.

United Biomedical, Inc (UBI) is a privately held multinational biopharmaceutical company dedicated to the discovery, development and commercialization of immunotherapeutics and vaccines for chronic and infectious diseases. Our product pipeline is filled with our new line of synthetic peptide-based biologicals for the treatment and prevention of Alzheimer’s Disease, AIDS, and Allergy, along with a portfolio of animal health diseases. These products are based on our proprietary designer peptides, vaccine formulation systems, and methods to manufacture therapeutic monoclonal antibodies. Our platform technologies are also being used to develop a line of biosimilar versions of widely used protein and antibody drugs whose patents are about to expire. UBI’s proprietary designer peptide technology has been used to produce a line of blood screening diagnostics and the first successfully commercialized synthetic peptide vaccine. Additional revenue streams are generated from pharmaceutical contract manufacturing by our subsidiary UBI-Asia and various sponsorships in product development.

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.

Xentria is a venture studio that provides capital and insight into breakthrough science that aligns with our core therapeutic areas to improve the lives of patients and their families. Since our formation in 2020, we've forged authentic partnerships to advance challenging drug development, addressing unmet needs with increased collaboration, tenacity, and partnership. We offer holistic support, enhanced operational efficiency, and long-term partnerships to drive growth and assist in navigating challenges for an increased chance of success.