Viatris Biosimilars

What Viatris Biosimilars does

Viatris Biosimilars is the biosimilars-focused segment of Viatris Inc. (NASDAQ: VTRS), a global pharmaceutical company formed in November 2020 through the combination of Mylan (founded 1961) and Upjohn (Pfizer's former Established Medicines division). The biosimilars unit concentrates on five core therapeutic areas: oncology, immunology, endocrinology, ophthalmology, and dermatology, complementing the broader Viatris portfolio of approximately 1,400 approved molecules. Viatris serves approximately 1 billion patients annually across 165+ markets and territories, reaching more than 90% of low- and middle-income countries through its Global Healthcare Gateway infrastructure. The business model combines generics, established brands, and innovative medicines, with revenue generated through product sales, licensing/royalty arrangements, and patient assistance programs.

The underlying technology centers on pharmaceutical manufacturing and drug delivery systems, including proprietary autoinjectors for self-administered medicines. Notable technical components include the selatogrel autoinjector designed for pre-hospital treatment of acute myocardial infarction, supported by human factors engineering and stress testing across diverse user populations. R&D and engineering operations span the U.S. (Morgantown, Canonsburg/Pittsburgh), Ireland (Dublin), the U.K. (Cambridge), Hungary (Komárom), India (Hyderabad), and China (Shanghai). Key products include biosimilars, a generics portfolio, established brands, and pipeline assets selatogrel (Phase 3 for AMI) and cenerimod (Phase 3 for SLE), both acquired through a 2024 global R&D collaboration with Idorsia involving a $350 million upfront payment.

Go-to-market leverages a hybrid model combining direct-to-patient distribution through global supply chains, enterprise field sales for innovative medicines, and patient assistance programs in the U.S. A major strategic shift is underway: Biocon Biologics is acquiring the remaining stake in the Viatris Biosimilars business for US$815 million, with full integration expected by March 31, 2026, in a transaction valuing Biocon Biologics at US$5.5 billion. Viatris holds FDA Fast Track designations for both selatogrel and cenerimod, and a Special Protocol Assessment for the SOS-AMI study. Strategic partnerships span the Bill & Melinda Gates Foundation, Gilead Sciences, TB Alliance, American College of Cardiology, and global health organizations, supporting access in low- and middle-income countries and NCD awareness initiatives.

Name

Viatris Biosimilars

Legal name

Viatris Inc.

Website

https://viatris.com

Company type

Public

Founded year

2020

Operating status

Operating

Headcount range

5,001–10,000 employees

Short description

Viatris Biosimilars is the biosimilars segment of Viatris Inc. (NASDAQ: VTRS), focused on oncology, immunology, endocrinology, ophthalmology, and dermatology, serving patients across 165+ markets. The unit is being divested to Biocon Biologics for $815M by March 2026.

Ownership category

akta.pro rank

Product category

Biosimilar Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254), Drugs and Druggists' Sundries Merchant Wholesalers (424210), Surgical and Medical Instrument Manufacturing (339112)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Oncology Biosimilars (HLAAAHAG)

akta.pro secondary industries

Biosimilar Commercialization & Market Access (pricing, tendering, interchangeability, distribution) (HLAAAHAL), Biologics & Biosimilars Distributors (HLAIAJAH)

Keywords

• Biosimilar medicines
• Generic pharmaceuticals
• Specialty therapeutics
• Oncology biosimilars
• Biologic drug delivery

Headquarters

HQ city

Canonsburg

HQ country

United States

HQ region

North America

Offices8 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Generic Medicines: Viatris offers a broad portfolio of generic pharmaceuticals spanning approximately 1,400 approved molecules across more than 10 major therapeutic areas, providing affordable access to high-quality medicines globally.
2. Established Brands: Viatris maintains established brand medicines alongside generics, uniquely bridging the traditional divide between generics and brands to holistically address healthcare needs globally.
3. Innovative Medicines Pipeline: Through collaboration with Idorsia, Viatris receives worldwide commercialization rights for Phase 3 assets including selatogrel and cenerimod, with potential milestone payments and tiered royalties in mid-single to low-double digit percentages on annual net sales.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels7 records

Core offering

Viatris Biosimilars develops, manufactures, and commercializes biosimilar medicines across oncology, immunology, endocrinology, ophthalmology, and dermatology therapeutic areas. The business also produces a broad portfolio of generic pharmaceuticals spanning approximately 1,400 approved molecules, supported by a global supply chain reaching 165+ markets and territories. Key pipeline assets include Selatogrel (a self-administered autoinjector for acute myocardial infarction) and Cenerimod (an oral therapy for systemic lupus erythematosus), both in Phase 3 development.

Product overview

Viatris is a global healthcare company that bridges the traditional divide between generics and brands. The company operates a unified portfolio model comprising generics, established brands, and innovative medicines. Key products include selatogrel (a self-administered autoinjector for acute myocardial infarction in Phase 3) and cenerimod (an oral therapy for systemic lupus erythematosus in Phase 3), both acquired through a collaboration with Idorsia. The portfolio also includes biosimilars, with Biocon planning to acquire Viatris' biosimilars business for US$815 million. The company serves approximately 1 billion patients annually across ~1,400 approved molecules in more than 10 major therapeutic areas across 165+ markets.

Differentiator

Problem solved

Functional benefit

Products and services

• Selatogrel Selatogrel is a potent, fast-acting, reversible, and highly selective P2Y12 inhibitor being developed for self-administered subcutaneous treatment of acute myocardial infarction (AMI) via autoinjector, targeting the pre-hospital phase to protect heart muscle during the critical 'golden hour' after symptom onset. It carries FDA Fast Track designation and a Special Protocol Assessment agreement.
• Cenerimod Cenerimod is a highly selective S1P1 receptor modulator given as an oral once-daily tablet for the treatment of systemic lupus erythematosus (SLE), the result of 20 years of research. It carries FDA Fast Track designation and represents a potentially novel oral approach for SLE patients.
• Generics Portfolio Broad portfolio of generic medicines spanning approximately 1,400 approved molecules across more than 10 major therapeutic areas, providing affordable access to high-quality medicines globally.
• Established Brands Portfolio Established brand medicines forming part of the dynamic global portfolio providing effective healthcare solutions at scale, bridging the traditional divide between generics and brands.
• Biosimilars Portfolio Biosimilar medicines focused on oncology, immunology, endocrinology, ophthalmology, and dermatology therapeutic areas. Biocon plans to acquire the remaining stake in the Viatris biosimilars business for US$815 million with full integration expected by March 31, 2026.
• Innovative Medicines Pipeline Innovative medicines as part of the global portfolio combining generics and brands to holistically address healthcare needs globally, including Phase 3 assets Selatogrel and Cenerimod.

Quantifiable outcome

• 1 billion patients reached annually with high-quality medicines
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

18 partnerships are on record, tiered core, key and minor.

• IdorsiacoreStrategic or Co-development Partner · 28 February 2024Significant global R&D collaboration under which Viatris receives exclusive global development and commercialization rights to two Phase 3 assets: selatogrel (potential self-administered treatment for acute myocardial infarction) and cenerimod (novel oral therapy for systemic lupus erythematosus). Viatris made $350 million upfront payment with potential development and regulatory milestones, sales milestones, and tiered royalties. Both companies contribute to development costs with Viatris holding worldwide commercialization rights.
• Bill and Melinda Gates FoundationcoreStrategic or Co-development PartnerPartnership to scale up access to affordable HIV treatment in low- and lower-middle-income countries, supporting global public health initiatives.
• Gilead SciencescoreStrategic or Co-development PartnerGlobal collaboration to expand access to the investigational antiviral remdesivir for the potential treatment of COVID-19 in various regions.
• TB AlliancecoreStrategic or Co-development PartnerPartnership to increase access to the molecule pretomanid as part of a three-drug tuberculosis regimen in many low-income countries.
• American College of CardiologykeyStrategic or Co-development PartnerPartnership to impact patient outcomes in cardiovascular and other noncommunicable disease areas through NCD awareness initiatives and global cardiovascular disease training and education programs. 44 live programs have reached nearly 70,000 clinicians in nearly 50 countries.
• NCD AlliancekeyStrategic or Co-development PartnerPartnership to research and illuminate the role of primary care healthcare workers in decreasing the burden of NCD, including the 'our Views our Voices' initiative in local communities.
• Dispensary of Hope, Americares, Direct ReliefcoreStrategic or Co-development PartnerPartnership to donate over 1.5 billion doses of medicine in the U.S. and around the world since 2007, improving access for underserved populations.
• Duke-National University of Singapore Medical SchoolkeyStrategic or Co-development PartnerPartnership to establish a center of excellence focusing on real-world evidence and systems thinking in Southeast Asia, supporting NCD research and treatment approaches.
• NYU Abu DhabikeyStrategic or Co-development PartnerUnique partnership to enhance research capabilities in the region by conducting bespoke training modules and utilizing NYU AD network with health authorities to generate real world evidence. Supports one of the largest NCD clinical trials, the Healthy Future Study.
• NCD Academy (with American College of Cardiology, World Heart Federation, NCD Alliance)keyStrategic or Co-development PartnerPartnership to provide physicians with access to digital resources and capabilities to enhance the prevention and treatment of noncommunicable diseases.
• Medicines for EuropeminorStrategic or Co-development PartnerCollaboration to help increase the health and wellbeing of all Europeans through better access to high quality medicines by removing gaps in access between branded product and generics.
• International Generic and Biosimilar Medicines Association (IGBA)minorStrategic or Co-development PartnerPartnership to increase global access to generics and biosimilar medicines worldwide.
• India's National Viral Hepatitis Control ProgramkeyStrategic or Co-development PartnerPartnership to supply medicine for more than 150,000 patients in more than 11 Indian states for viral hepatitis treatment.
• Clinton Health Access InitiativekeyStrategic or Co-development PartnerPartnership to improve access to essential medicines and healthcare in low- and middle-income countries.
• The Global FundkeyStrategic or Co-development PartnerPartnership to support global health initiatives and improve access to treatments for HIV, tuberculosis, and malaria in developing countries.
• Elton John AIDS FoundationkeyStrategic or Co-development PartnerPartnership to support HIV/AIDS programs and improve access to treatment and care for affected populations.
• UNAIDSkeyStrategic or Co-development PartnerPartnership to support global efforts to end AIDS as a public health threat by 2030.
• Emirates Airlines (Health Matters Initiative)minorStrategic or Co-development PartnerInnovative partnership to develop short, educational, animated videos on diverse NCD topics for Emirates infotainment platform ICE.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Organon & Co. Organon was spun out of Merck in 2021 with a portfolio heavy in women's health, biosimilars, and established brands. Its biosimilars franchise (especially immunology) overlaps with Viatris Biosimilars' endocrinology and immunology focus.
• Amgen (biosimilars franchise): Amgen operates a well-established biosimilars business (AMJEVITA, IMRALDI, etc.) alongside its innovative biologics pipeline. It is a broad incumbent with overlapping oncology and immunology biosimilars and superior biologic development capabilities.
• Pfizer (biosimilars division): Pfizer maintains a significant biosimilars portfolio through its established biologics business inherited from Hospira and expanded via the Seagen and Wyeth integrations. It is a broad incumbent competing across many of the same oncology and immunology indications as Viatris Biosimilars.

Direct peers

• Sandoz (Novartis): Sandoz is the global biosimilars and generics leader spun out of Novartis in 2023, with a comparable biosimilars portfolio across oncology, immunology, and endocrinology. It is the most direct competitor to Viatris Biosimilars in biologic commercialization and interchangeability strategy.
• Samsung Bioepis: Samsung Bioepis is a biosimilars-focused biotech with approved biosimilars in oncology, immunology, and ophthalmology. It competes head-to-head with Viatris Biosimilars in major regulated biosimilar markets through its commercialization partner Biogen.
• Biocon Biologics: Biocon Biologics is the acquirer of the Viatris biosimilars business and a leading pure-play biosimilars developer with oncology and immunology focus. The two companies are merging biosimilar assets, making Biocon the closest functional peer in biosimilar development and commercialization.
• Teva Pharmaceutical Industries: Teva is a global generics and specialty pharmaceutical company with a meaningful biosimilars pipeline. Its broad therapeutic coverage across 60+ markets and large generic footprint directly overlap with Viatris Biosimilars' positioning across oncology, immunology, and dermatology.

Emerging players

• Alvotech: Alvotech is an Iceland-based pure-play biosimilars developer focused on immunology, ophthalmology, and oncology biosimilars with a vertically integrated platform. It is an emerging competitor with a similarly broad therapeutic mix as Viatris Biosimilars.
• Hikma Pharmaceuticals: Hikma is a multinational generics and specialty pharmaceutical company with growing biosimilars interests across immunology and oncology. It shares Viatris Biosimilars' emphasis on injectable and complex generics across MENA, Europe, and the U.S.
• Celltrion Healthcare: Celltrion is a Korean biosimilars developer with approved products in oncology and immunology (Remsima, Truxima, Herzuma). It is an emerging player expanding aggressively in global biosimilar markets in direct competition with Viatris Biosimilars.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

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Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Viatris Biosimilars