Amgen
Amgen Inc. is a leading global biopharmaceutical company focusing on the discovery, development, manufacture, and delivery of innovative human therapeutics. The company targets a variety of serious disease indications, including oncology/hematology, inflammation, and cardiovascular disorders. Amgen has established a significant and successful biosimilars business, which has become a key driver of its growth and market presence. Its robust portfolio includes eight approved biosimilar products spanning rare disease, inflammation, and oncology segments. These products, such as AVSOLA, have collectively generated cumulative sales of USD 10 billion through the third quarter of 2024, demonstrating their commercial success and impact on patient care. Amgen’s ongoing efforts include the planned US launches of new biosimilars like the aflibercept biosimilar PAVBLU, and the eculizumab biosimilar Bekemv in Q2 2025. The company leverages its expertise in human genetics and complex biological manufacturing to ensure the high quality and efficacy of its biosimilars, reinforcing its commitment to making life-saving medicines more accessible globally.
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Pfizer
Pfizer, Inc. is a world-renowned pharmaceutical corporation with a history exceeding 175 years, distinguished as a pioneer in human health across diverse therapeutic areas. The company’s extensive portfolio encompasses medicines, vaccines, and a leading range of approved oncology medications. In the biosimilars market, Pfizer maintains a robust and continually growing presence, offering a portfolio of biosimilars across more than 40 indications, including oncology. The company’s oncology biosimilars, such as Retacrit, Ruxience, Zirabev, Trazimera, and Nivestym, contributed unaudited revenues of over USD 1 billion for the full year 2024. Pfizer is strategically positioned to capitalize on future biosimilars disruption, ranking among the top companies in this sector based on investments and drug development strategy. The company is actively expanding its offerings with major launches planned for 2025, including Pyzchiva and Wyost® / Jubbonti, which are biosimilars for Ustekinumab and Denosumab, respectively. This strategic focus highlights Pfizer’s commitment to delivering high-quality, more affordable biologic therapies to patients worldwide.
Sandoz
Sandoz, now operating as an independent publicly traded company following its spin-off from Novartis, is a global leader and dedicated champion in the biosimilars and generics market. Established in 1886, Sandoz launched Europe’s first biosimilar, Omnitrope, in 2006, positioning itself as a key figure in the industry’s early growth. The company boasts a diverse and deep portfolio of biosimilars across therapeutic areas like oncology, immunology, and endocrinology, including prominent products such as Zarxio, Erelzi, and Hyrimoz. Sandoz’s pivotal role lies in expanding global access to biologic therapies through the development and commercialization of high-quality, affordable biosimilars. Its success is underpinned by strategic partnerships, extensive global manufacturing capabilities, and a consistent focus on regulatory compliance. Recent approved products like Tyruko (natalizumab-sztn), Jubbonti (denosumab-bbdz), and Enzeevu (aflibercept-abzv) reinforce Sandoz’s commitment to providing crucial alternatives to reference biologics and driving the sustainability of healthcare systems globally.
Celltrion
Celltrion is a prominent South Korean biopharmaceutical company recognized for its extensive expertise in the research, development, and manufacturing of biosimilars. Founded in 2002, the company made history by being the first to receive FDA approval for a monoclonal antibody biosimilar. Celltrion has a strong, commercially successful portfolio featuring flagship products such as Remsima (infliximab), Truxima (rituximab), and Herzuma (trastuzumab). Its innovation in manufacturing processes, coupled with a commitment to quality and affordability, has solidified its position as a key global player. Celltrion actively pursues regulatory approvals in major markets, exemplified by its recent EC approval in February 2025 for multiple biosimilars, including Eydenzelt (aflibercept) and Avtozma (tocilizumab). The company is also focused on expanding its commercial footprint by moving towards distributing in-house in the U.S. and continuing to export to over 110 countries, with a plan to launch its Ustekinumab biosimilar, Steqeyma, in the US in February 2025.
Samsung Bioepis
Samsung Bioepis, a subsidiary of Samsung Biologics, is a dynamic South Korean biopharmaceutical company specializing in the rapid development and commercialization of biosimilars. Since its founding in 2012, the joint venture between Samsung and Biogen has established a strong reputation for speed in development and regulatory filings, successfully becoming the first Korean company to enter the EU biosimilars market. The company has a broad pipeline and already has nine approved products across a spectrum of therapeutic areas, including immunology, oncology, and ophthalmology. Samsung Bioepis has secured recent FDA approvals for Pyzchiva (Stelara biosimilar), Epysqli (Soliris biosimilar), and Opuviz (Eylea biosimilar), with the latter achieving interchangeable status. By leveraging its parent company’s expertise in large-scale biologics manufacturing and focusing on quality assurance, Samsung Bioepis plays a crucial role in expanding the adoption of high-quality, more affordable biosimilar alternatives globally.
Biocon Biologics
Biocon Biologics, the biosimilars arm of the Indian biopharma company Biocon, is a major global force known for its cost-efficient, vertically integrated business model spanning R&D, manufacturing, and commercialization. The company has a strong focus on increasing patient access to affordable biologic medicines. It was instrumental in co-developing Semglee, the first interchangeable insulin biosimilar approved in the U.S., through a partnership with Mylan (now Viatris). Biocon Biologics has successfully launched other key biosimilars, including Fulphila (biosimilar to Neulasta) and Ogivri (biosimilar to Herceptin). A pivotal shift occurred when Biocon acquired Viatris’s biosimilars business, granting it direct commercialization rights in developed markets like the U.S. and Europe, thereby evolving from a B2B model to a B2C model. This strategic move, along with collaborations with companies like Sandoz, reinforces Biocon Biologics’ dedication to advancing its portfolio in immunology and oncology worldwide.
Viatris
Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, positioning itself as a significant and strategic player in the biosimilars market. The company is committed to increasing patient access to affordable, high-quality biologic therapies globally, particularly within emerging markets. Viatris offers a substantial portfolio of biosimilar versions of complex drugs, including adalimumab, trastuzumab, and insulin glargine. The company’s strategy often involves strategic partnerships, such as its long-term collaboration with Biocon Biologics, which led to the commercialization of products like Fulphila and Ogivri, as well as the first interchangeable insulin biosimilar, Semglee. Viatris’s continued involvement and expertise in development, marketing, and distribution are vital to the expansion and growth of the global biosimilars industry, ensuring more accessible treatment options for diverse patient populations.
Alvotech
Alvotech is a specialty biopharmaceutical company headquartered in Iceland, dedicated to the development and manufacturing of high-quality biosimilars for global markets. The company’s core focus is on creating alternatives for complex reference biologics, particularly targeting immunology and chronic diseases. Alvotech has successfully navigated the regulatory landscape, resulting in the approval of two key biosimilars: Selarsdi, a biosimilar to J&J’s Stelara, and Simlandi, a biosimilar to AbbVie’s Humira. These approvals, often achieved through strategic commercial partnerships with global pharmaceutical companies like Teva Pharmaceutical, highlight Alvotech’s ability to bring complex products to market. Simlandi, for instance, is approved for the treatment of various conditions including adult rheumatoid arthritis, Crohn’s disease, and plaque psoriasis. By concentrating on end-to-end development and manufacturing, Alvotech plays a crucial role in driving down costs and expanding treatment options for chronic conditions.
Coherus BioSciences
Coherus BioSciences is a commercial-stage biopharmaceutical company based in the US, with a strategic focus on immunotherapies, including the development and commercialization of a portfolio of FDA-approved biosimilars. The company has quickly established a strong market presence with its product Udenyca (pegfilgrastim), which achieved significant market share in the U.S. soon after launch. Coherus is committed to providing high-quality biosimilars and has expanded its portfolio with Cimerli (ranibizumab), which is the first and only interchangeable biosimilar to Lucentis, demonstrating its commitment to interchangeability and patient access. While rooted in biosimilars, Coherus is also diversifying its pipeline by partnering to introduce novel treatments like the PD-1 checkpoint inhibitor toripalimab, marking its expansion into the immuno-oncology space while maintaining a strong commitment to the biosimilars mission.
Formycon
Formycon is a German biopharmaceutical company with a core focus on the development of biosimilars, primarily targeting indications in ophthalmology and immunology, as well as other key chronic diseases. The company is committed to the complex process of creating biosimilar versions of advanced biologics to offer more affordable treatment options. Formycon currently has three biosimilars on the market, including its ranibizumab biosimilar, FYB201 (biosimilar to Genentech’s Lucentis). This product achieved both FDA and EC approval in 2022, underscoring Formycon’s expertise in navigating rigorous global regulatory pathways. By concentrating its research and development efforts on complex biological drugs with high market potential, Formycon is contributing to the crucial expansion of therapeutic choices for patients suffering from long-term, debilitating conditions.
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