| Company | Headquarter | Annual Revenue (2024) | Established Year |
| Samsung Bioepis Co., Ltd. | Incheon, South Korea | USD 850 million | 2012 |
| Celltrion Inc. | Incheon, South Korea | USD 2.6 billion | 2002 |
| Amgen Inc. | Thousand Oaks, USAThousand Oaks, USA | USD 28.2 billion | 1980 |
| Novartis International AG | Basel, Switzerland | USD 54.4 billion | 1996 |
| Pfizer Inc. | New York City, USA | USD 58.5 billion | 1849 |
Headquartered in Incheon, South Korea, Samsung Bioepis was founded in 2012 as a joint venture between Samsung and Biogen.
The company specializes in developing biosimilar medicines across various therapeutic areas, including immunology, oncology, and ophthalmology.
It operates with a mission to enhance healthcare accessibility and affordability through high-quality biologics.
Benepali (etanercept): Biosimilar to Enbrel for autoimmune diseases.
Flixabi (infliximab): Biosimilar to Remicade for inflammatory disorders.
Ontruzant (trastuzumab): Biosimilar to Herceptin for HER2-positive breast cancer.
Expanded biosimilar accessibility across over 35 countries, improving patient affordability.
Enhanced healthcare sustainability by reducing treatment costs through biologic alternatives.
Partnered with global firms like Biogen and Organon for worldwide distribution.
In 2025, Samsung Bioepis launched SB16, a biosimilar referencing Prolia/Xgeva (denosumab).
Continued investment in AI-driven analytics to accelerate biologics development.
Strengthened U.S. and EU presence with multiple product approvals.
Introduction:
Samsung Bioepis aimed to expand biosimilar access across Europe to challenge existing biologic monopolies.
Challenges Faced:
Regulatory hurdles and diverse market authorization processes.
Physician and patient resistance toward biosimilar adoption.
Competitive pricing pressure from established pharmaceutical firms.
Solutions Implemented:
Formed alliances with Biogen and Organon to navigate regional markets.
Conducted robust real-world studies to validate product efficacy and safety.
Leveraged efficient manufacturing to maintain competitive pricing.
Outcome:
Gained over 40% market share in key European biosimilar segments.
Achieved rapid adoption among physicians through data transparency.
Strengthened patient trust and brand credibility.
Strategies Taken:
Prioritized clinical data publication in peer-reviewed journals.
Enhanced post-marketing surveillance systems.
Expanded R&D investment to maintain biosimilar pipeline momentum.
Established in 2002 and headquartered in Incheon, South Korea.
A global leader in biopharmaceutical innovation, focusing on biosimilars and novel biologics.
Operates with a vertically integrated model covering R&D, manufacturing, and commercialization.
Remsima (infliximab): The world’s first monoclonal antibody biosimilar.
Truxima (rituximab): Biosimilar for blood cancers and autoimmune diseases.
Herzuma (trastuzumab): Biosimilar for HER2-positive cancers.
Pioneered the global acceptance of monoclonal antibody biosimilars.
Established large-scale biopharmaceutical manufacturing in Asia.
Exported products to over 110 countries, improving global access.
In 2025, launched Zymfentra, the first subcutaneous infliximab formulation approved in the U.S.
Invested in antibody-drug conjugate (ADC) development.
Expanded operations into digital healthcare and cell therapy platforms.
Introduction:
Celltrion sought to enter the U.S. autoimmune disease market with Remsima SC, its subcutaneous biosimilar formulation.
Challenges Faced:
Intense competition from established biologics.
Stringent U.S. FDA regulatory standards.
Limited physician familiarity with SC biosimilars.
Solutions Implemented:
Conducted clinical trials demonstrating improved patient convenience.
Partnered with Teva Pharmaceuticals for U.S. commercialization.
Developed targeted awareness programs for clinicians.
Outcome:
Received FDA approval and achieved high initial market uptake.
Reduced hospital administration costs through at-home injection options.
Strengthened Celltrion’s position in the North American market.
Strategies Taken:
Focused on patient-centric delivery models.
Leveraged real-world data to showcase efficacy and safety.
Expanded digital marketing to enhance outreach to healthcare providers.
Founded in 1980, headquartered in Thousand Oaks, California, USA.
A global biotechnology pioneer focusing on therapies for oncology, cardiovascular diseases, and inflammation.
Known for translating science into life-changing medicines using advanced biotechnological platforms.
Enbrel (etanercept): For autoimmune diseases.
Prolia (denosumab): For osteoporosis.
Repatha (evolocumab): For cholesterol management.
Operates in over 100 countries serving millions of patients.
Contributed significantly to biologics innovation and genetic research.
Invested heavily in environmental sustainability and access initiatives.
In 2025, introduced BLINCYTO SC, a subcutaneous formulation of blinatumomab for leukemia.
Expanded its biosimilar portfolio with Amjevita (adalimumab) launch in the U.S.
Focused on AI integration for clinical trial optimization.
Introduction:
Amgen launched Amjevita, the first U.S. adalimumab biosimilar, competing with Humira.
Challenges Faced:
Strong brand loyalty toward Humira.
Complex pricing and insurance structures.
Intense competition from multiple biosimilar entrants.
Solutions Implemented:
Introduced dual pricing models to appeal to diverse payers.
Collaborated with insurers for formulary inclusion.
Conducted large-scale education campaigns for prescribers.
Outcome:
Achieved double-digit U.S. biosimilar market share in its first year.
Reduced overall treatment cost for autoimmune diseases.
Set a precedent for biosimilar commercialization strategies.
Strategies Taken:
Adopted transparent pricing models.
Enhanced supply chain reliability.
Reinforced brand through scientific engagement programs.
Founded in 1996 through the merger of Ciba-Geigy and Sandoz, headquartered in Basel, Switzerland.
Focuses on innovative pharmaceuticals, generics, and biosimilars.
Operates with Sandoz as a separate global leader in biosimilars and generics.
Cosentyx (secukinumab): For psoriasis and ankylosing spondylitis.
Kymriah (tisagenlecleucel): CAR-T therapy for leukemia.
Entresto (sacubitril/valsartan): For heart failure management.
Serves patients in more than 150 countries.
Pioneered CAR-T cell therapy introduction in oncology.
Contributed significantly to global access through generics division Sandoz.
Launched next-generation CAR-T therapy manufacturing facilities in Switzerland in 2025.
Expanded digital clinical trials using decentralized platforms.
Invested in sustainability programs reducing carbon emissions by 30%.
Introduction:
Novartis aimed to commercialize CAR-T therapy globally for blood cancers.
Challenges Faced:
High production cost and limited availability.
Complex logistics for personalized therapies.
Regulatory diversity across countries.
Solutions Implemented:
Developed modular manufacturing hubs.
Partnered with hospitals for local production.
Worked with regulators to streamline approval processes.
Outcome:
Became the world’s first approved CAR-T therapy.
Improved remission rates in leukemia patients.
Set industry benchmarks for cell therapy manufacturing.
Strategies Taken:
Invested in digital tracking for supply chain transparency.
Implemented patient assistance programs.
Strengthened academic collaborations for future cell therapy research.
Founded in 1849, headquartered in New York City, USA.
One of the world’s largest pharmaceutical companies with expertise in vaccines, oncology, and internal medicine.
Operates in over 120 countries with a focus on innovation and patient impact.
Comirnaty (COVID-19 vaccine): Developed with BioNTech.
Ibrance (palbociclib): For breast cancer.
Prevnar 20: Pneumococcal vaccine.
Delivered over 4 billion COVID-19 vaccine doses globally.
Established strong partnerships in global health and pandemic response.
Contributed to vaccine equity through global alliances.
In 2025, Pfizer announced AI-based drug discovery partnerships with NVIDIA.
Expanded its oncology portfolio with multiple pipeline candidates.
Invested in RNA-based therapeutic platforms beyond vaccines.
Introduction:
Pfizer developed and distributed the first mRNA COVID-19 vaccine worldwide.
Challenges Faced:
Accelerated regulatory timelines.
Global cold-chain logistics.
Vaccine hesitancy and misinformation.
Solutions Implemented:
Partnered with BioNTech for mRNA technology.
Deployed specialized ultra-cold storage networks.
Collaborated with governments for awareness campaigns.
Outcome:
Vaccinated billions, reducing global mortality rates.
Set new standards for vaccine R&D speed.
Strengthened Pfizer’s position as an innovation leader.
Strategies Taken:
Built agile R&D collaboration frameworks.
Established transparent communication with global health agencies.
Scaled production capabilities through regional manufacturing hubs.
The global oncology biosimilars market size is calculated at US$ 6.7 billion in 2024, grew to US$ 7.94 billion in 2025, and is projected to reach around US$ 36.23 billion by 2034. The market is expanding at a CAGR of 18.47% between 2025 and 2034.
Pricing discounts and cost competition: The oncology biosimilars market is defining the aspect of pricing. Manufacturers are offering up to 50-80% discounts in order to gain formulary access and drive uptake. These price reductions lead to a competitive dynamic and enhance affordability. This expands its access across diverse healthcare systems. Samsung Bioepis stated that newly launched biosimilars in the U.S. are available with a wholesale acquisition cost discount of almost 80%. The FDA and European EMA are also actively considering streamlining biosimilar development in order to accelerate market entry and make development smoother.
Rising Collaborations and development: Strategic partnerships between global biotech and pharmaceutical companies are pushing the oncology biosimilars market ahead. These alliances help to speed up timelines and expand market reach. By joining forces, companies can pool their resources together, work with each other’s strengths, and bring deep expertise in biologics innovation and process development. This collaborative approach helps to mitigate risks, broaden geographic reach, and quickly introduce these drugs in the market. This increases the patient’s access to advanced cancer care, where timing is everything.
Key R&D steps includ extensive analytical characterization, non-clinical studies, and clinical trials, all culminating in a "totality of evidence" supporting biosimilarity.
Key players include: Sandoz, Celltrion, Amgen, Pfizer, and Samsung Bioepis.
Key steps include establishing biosimilarity through extensive analytical comparisons, non-clinical studies (including in vitro and in vivo assessments), and clinical trials that demonstrate comparable efficacy and safety to the reference biologic.
Key players include: Sandoz, Celltrion, Amgen, Pfizer, and Samsung Bioepis.
These services often mirror those offered for reference biologics, including reimbursement support, educational resources, and adherence programs, but may also include specific initiatives to address concerns about biosimilarity. Key areas of focus include reimbursement assistance, education about biosimilarity, and copay support programs.
Key players include: Sandoz, Celltrion, Pfizer, Amgen, Samsung Bioepis, Biogen, Merck & Co., and Coherus Biosciences
In April 2025, Kevin Ali, Organon’s Chief Executive Officer, announced that their company had acquired regulatory and commercial rights in the U.S. for Tofidence, a biosimilar to Actemra for intravenous infusion. Organon has acquired the regulatory and commercial rights to Tofidence in the U.S, and it will be available in three vial sizes: 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL.
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