What Polpharma Biologics does

Polpharma Biologics is a European biopharmaceutical company that develops, manufactures, and out-licenses biosimilar medicines. Founded as the biotech division of Polpharma in 2010 and spun off as an independent entity in 2019, the company underwent a structural transformation in September 2025, with its biosimilars business relocating to Zug, Switzerland, while its CDMO operations spun out as Rezon Bio in Poland. The company maintains integrated capabilities spanning cell line development (Utrecht, Netherlands), R&D and drug substance manufacturing (Gdańsk, Poland), and commercial-scale manufacturing with twin 2000L bioreactor capacity (Warsaw-Duchnice, Poland). It employs approximately 900 specialists across these operations, with over 10% holding doctoral degrees.

Polpharma Biologics operates a pure B2B out-licensing model with no direct commercialization. It develops biosimilars through clinical and regulatory stages, then partners with global pharmaceutical companies that handle commercialization, marketing, and distribution in licensed territories. Commercial partners include Sandoz (global for natalizumab), Teva (Europe/Canada for ranibizumab), Fresenius Kabi (global ex-MENA for vedolizumab), and others. Revenue flows from upfront payments, development milestones, supply agreements, and commercial royalties. The company holds a 50% stake in the Bioeq AG joint venture with Formycon AG for ranibizumab commercialization.

The product portfolio includes two FDA/EMA-approved biosimilars, Tyruko (natalizumab, the first and only FDA-approved MS biosimilar, launched in the US in November 2025) and Ranivisio/NUFYMCO (ranibizumab for ophthalmology, available in 22 countries), plus a pipeline of three biosimilars in development: PB016 (vedolizumab), PB018 (ocrelizumab), and PB019 (guselkumab). The company is privately controlled by Polish entrepreneur Jerzy Starak and is not publicly traded.

Name

Polpharma Biologics

Legal name

Polpharma Biologics S.A.

Website

https://polpharmabiologics.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Polpharma Biologics is a Switzerland-based biopharmaceutical company that develops, manufactures, and out-licenses biosimilar medicines to global pharmaceutical partners, with two FDA/EMA-approved products (natalizumab and ranibizumab) and a pipeline targeting neurology, ophthalmology, gastroenterology, and autoimmune diseases.

Ownership category

akta.pro rank

Product category

Biosimilar Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Monoclonal Antibody (mAb) Biosimilars (HLAIAFAA)

akta.pro secondary industries

Process Development & Tech Transfer Services (upstream/downstream) (HLAAAKAF), GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL)

Keywords

• Biosimilar development
• Biologics manufacturing
• Monoclonal antibody biosimilars
• Cell line development
• Pharmaceutical out-licensing

Headquarters

HQ city

Gdansk

HQ country

Poland

HQ region

Europe

Offices6 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Biosimilar Out-licensing: Polpharma Biologics develops biosimilars through clinical stages and out-licenses commercialization rights to pharmaceutical partners. The company retains responsibility for development, manufacturing, and supply while partners handle commercialization, marketing, and distribution. Revenue flows from upfront payments, development milestones, and commercial royalties based on partner sales.
2. CDMO Services: Through its former CDMO operations (now operating as Rezon Bio), Polpharma Biologics provides contract development and manufacturing services for biologics to external biotech and pharmaceutical companies. Services include cell line development, process development, clinical and commercial manufacturing, and fill-finish capabilities.
3. Joint Venture (Bioeq): Polpharma Biologics holds 50% stake in Bioeq AG, a joint venture with Formycon AG for development and commercialization of biosimilars including ranibizumab. Revenue shared from commercialization agreements with partners like Teva, Coherus, and Zydus.

Go-to-market motion3 records

Distribution channels8 records

Marketing channels7 records

Core offering

Polpharma Biologics develops and manufactures biosimilar medicines through integrated capabilities spanning cell line development, process development, clinical manufacturing, and commercial-scale production using mammalian and microbial expression systems. The company out-licenses its biosimilars (natalizumab Tyruko®, ranibizumab Ranivisio®/NUFYMCO®, plus pipeline candidates PB016, PB018, PB019) to global pharmaceutical partners who commercialize, market, and distribute them in licensed territories worldwide.

Product overview

Polpharma Biologics is a biopharmaceutical group that develops and manufactures biosimilar medicines. Following a 2025 demerger, the company operates its biosimilars business under the Polpharma Biologics brand from Switzerland, while its CDMO services are now provided by Rezon Bio from Poland. The commercialized biosimilar portfolio includes Tyruko® (natalizumab) for multiple sclerosis and Crohn's disease, Ranivisio®/NUFYMCO® (ranibizumab) for ophthalmology indications, with additional pipeline candidates PB016 (vedolizumab), PB018 (ocrelizumab), and PB019 (guselkumab) in development. The company leverages contract development and manufacturing partners to deliver end-to-end biosimilars from cell line development to finished products across major therapeutic areas including neurology, immunology, gastroenterology, and ophthalmology.

Differentiator

Problem solved

Functional benefit

Brands

• Tyruko: Natalizumab biosimilar brand for multiple sclerosis, commercialized by Sandoz in the US
• Ranivisio
• ONGAVIA
• CIMERLI
• RANOPTO
• NUFYMCO

Products and services

• Tyruko® (natalizumab-sztn) First and only FDA-approved biosimilar of natalizumab for treatment of relapsing forms of multiple sclerosis (MS) and adult patients with moderately to severely active Crohn's disease. Commercialized by Sandoz under exclusive global license; available in U.S. and 14 European countries.
• Ranivisio® (ranibizumab) Biosimilar to Lucentis® (ranibizumab) approved for treatment of debilitating retinopathies including neovascular age-related macular degeneration (AMD), diabetic macular edema, proliferative diabetic retinopathy, and macular edema following retinal vein occlusion. Available in EU, US, UK, Canada, Brazil and 22 countries worldwide under different tradenames including Ranivisio, ONGAVIA, CIMERLI, and RANOPTO.
• Ranivisio® PFS (ranibizumab pre-filled syringe) First Lucentis® biosimilar offered in pre-filled syringe presentation in Europe. Used for treatment of neovascular (wet) age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. Pre-filled syringe presentation enables precise dosing and ease of use for ophthalmic treatments.
• NUFYMCO® (interchangeable ranibizumab biosimilar) Interchangeable biosimilar to Lucentis® (ranibizumab) with BLA approved by USFDA. Commercialized by Zydus Lifesciences in the United States under licensing, supply and commercialization agreement.
• PB016 (vedolizumab biosimilar) Proposed biosimilar to Entyvio® (vedolizumab), an integrin receptor antagonist for moderate to severe ulcerative colitis and Crohn's disease. Licensed globally (excluding MENA) to Fresenius Kabi for commercialization; Polpharma Biologics leads development and manufacturing. Phase 1 PK/PD comparability demonstrated.
• PB018 (ocrelizumab biosimilar) Proposed biosimilar to Ocrevus® (ocrelizumab), an anti-CD20 monoclonal antibody therapy for treatment of relapsing and primary progressive forms of Multiple Sclerosis. In Phase 1 clinical development; licensed to MS Pharma for the MENA region.
• PB019 (guselkumab biosimilar) Proposed biosimilar to guselkumab (Tremfya®), a monoclonal antibody targeting IL-23 for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis. Licensed to MS Pharma for MENA region commercialization.

Quantifiable outcome

• First and only FDA-approved biosimilar for natalizumab for multiple sclerosis treatment
• +3 more outcomes

Named customers9 records

Segments5 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Eleven partnerships are on record, tiered supporting, major, core and strategic.

• PSI CROsupportingImplementation/ SI/ Consulting Partner · 3 June 2026Collaboration for execution of Phase 1 clinical study evaluating PB018, a proposed biosimilar to Ocrevus (ocrelizumab), in patients with Multiple Sclerosis. Randomized, double-blind, parallel-group study to compare PK, PD, safety, and immunogenicity. Study expected to begin October 2026 with approximately 222 participants.
• TuteurmajorChannel Partner/ Reseller/ Distributor · 22 May 2026Licensing agreement for autoimmune disease biosimilar across Latin America excluding Brazil. Tuteur obtains exclusive rights to commercialize; Polpharma retains full responsibility for development and manufacturing. Regulatory submission anticipated within three years.
• Zydus LifesciencesmajorChannel Partner/ Reseller/ Distributor · 23 December 2025Licensing, supply, and commercialization agreement for NUFYMCO (biosimilar ranibizumab), an interchangeable biosimilar to Lucentis, in the United States. Bioeq oversees development, manufacturing, registration and supply; Zydus responsible for commercialization. BLA approved by FDA.
• Libbs FarmacêuticamajorChannel Partner/ Reseller/ Distributor · 10 December 2025Licensing agreement for autoimmune disease biosimilar commercialization in Brazil. Libbs gains exclusive rights to commercialize; Polpharma retains full responsibility for development and manufacturing. Regulatory submission expected within three years.
• MS PharmacoreChannel Partner/ Reseller/ Distributor · 2 September 2025Licensing agreements for commercialization of vedolizumab (PB016), ocrelizumab (PB018), and guselkumab (PB019) biosimilars in MENA region. MS Pharma responsible for registration, marketing, and distribution. Fill and finish activities to be transferred to MS Pharma's biologics manufacturing facility in Saudi Arabia.
• Fresenius KabicoreChannel Partner/ Reseller/ Distributor · 5 August 2025Global (except Middle East & North Africa) licensing agreement for commercialization of PB016, a proposed biosimilar to vedolizumab (Entyvio) for ulcerative colitis and Crohn's disease. Polpharma leads development and manufacturing; Fresenius Kabi holds exclusive commercialization rights worldwide excluding MENA.
• Biomm SAmajorChannel Partner/ Reseller/ Distributor · 4 June 2025Brazil exclusive commercialization partner for Ranivisio (ranibizumab biosimilar) for treatment of debilitating retinopathies approved by ANVISA. Polpharma Biologics manufactures drug substance and passed ANVISA inspection receiving Brazilian GMP certificate.
• Chime BiologicsstrategicStrategic or Co-development Partner · 16 April 2025Strategic partnership for end-to-end development and manufacture of a biosimilar product for the global market. Chime provides integrated support from IND stage through commercial supply. Specific therapy and indication not disclosed.
• University of WarsawsupportingStrategic or Co-development Partner · 25 August 2020Academic, scientific and technological cooperation agreement. Joint activities include training of biotechnology specialists and joint research projects. Part of building international scientific cooperation platform.
• Sandoz AGcoreChannel Partner/ Reseller/ Distributor · 3 September 2019Global commercialization agreement for natalizumab biosimilar. Polpharma Biologics responsible for development, manufacturing and supply. Sandoz commercializes and distributes upon approval under exclusive global license. The biosimilar (Tyruko) received FDA approval and launched in US in November 2025, and is available in 14 European countries.
• Bioeq AGcoreStrategic or Co-development PartnerJoint venture between Polpharma Biologics Group and Formycon AG for development, licensing, and commercialization of biosimilars including ranibizumab (Ranivisio/NUFYMCO). Polpharma holds 50% stake. Bioeq coordinates development while partners manufacture drug substance (Polpharma) and commercialize globally (Teva, Coherus, Zydus, MS Pharma, Biomm).

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Coherus BioSciences: Coherus is a US-based biosimilar-focused biopharma (Cimerli ranibizumab, Yusimry adalimumab, Udenyca pegfilgrastim) and is also a Polpharma commercialization partner for Ranivisio in the US. As a pure-play biosimilar company, it is a tight peer with comparable economics and target markets.
• Celltrion: Celltrion is one of the world's leading biosimilar developers (Remsima/Inflectra, Truxima, Herzuma, Yukarcin, Vegzelma). It is a direct competitor in mAb biosimilars across oncology and immunology, and like Polpharma pursues global out-licensing and direct commercialization in select geographies.
• Samsung Bioepis: Samsung Bioepis is a major biosimilar developer commercializing multiple biosimilars (etanercept, adalimumab, trastuzumab, ranibizumab/SB11, bevacizumab). It directly competes with Polpharma's Ranivisio in the ranibizumab biosimilar market and pursues an out-licensing model with Biogen/Samsung.
• Biocon Biologics: Biocon Biologics is a leading biosimilar developer (trastuzumab, bevacizumab, adalimumab, pegfilgrastim, insulin glargine) with integrated manufacturing. Like Polpharma, it uses out-licensing partners (Viatris) for global reach and is pursuing its own pipeline in autoimmune and oncology biosimilars.
• Zydus Lifesciences: Zydus Lifesciences (Cadila) is a vertically integrated Indian biosimilar and generics developer that commercializes its own products in the US, India, and emerging markets. It is a Polpharma commercialization partner for NUFYMCO in the US and pursues a directly comparable biosimilar portfolio across immunology, oncology, and ophthalmology.
• Alvotech: Alvotech is a vertically integrated biosimilar developer and manufacturer with a comparable focus on monoclonal antibody biosimilars (ranibizumab, adalimumab, ustekinumab, denosumab). Like Polpharma, it operates a hub-and-spoke model with manufacturing in Iceland/India and global commercialization partners, and competes directly in the ophthalmology biosimilar space with Polpharma's Ranivisio.
• Formycon AG: Formycon is Polpharma's Bioeq AG joint venture partner and an independent biosimilar developer (FYB201 ranibizumab, FYB202/203 ustekinumab, FYB206 Keytruda biosimilar). It is a direct comparable in biosimilar pipeline strategy and has the same IP/commercialization partner model.

Broad incumbents

• Amgen: Amgen operates a biosimilar business unit (Amgevita, Kanjinti, Mvasi, Soliris biosimilars) as part of a much broader biopharma portfolio. It is a relevant comparable given Polpharma's mAb biosimilar focus, though Amgen is also a competitor (e.g., Amgevita vs. adalimumab biosimilars) and a peer biologics developer.
• Sandoz: Sandoz (recently spun off from Novartis) is the world's largest generic and biosimilar medicines company, developing and commercializing biosimilars (Hyrimoz, Omnitrope, Erelzi, Zessly, Tyruko). It is both Polpharma's largest commercial partner (Tyruko global rights) and a competitor in the biosimilar space.
• Teva Pharmaceutical Industries: Teva is the world's largest generic drug manufacturer with a biosimilars business, including Tbo-filgrastim and partnerships (Polpharma's Ranivisio in EU/Canada). It is both a direct competitor in biosimilars and a Polpharma commercialization partner, making it a relevant broad-incumbent peer.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/polpharmabiologics

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Subsidiaries3 records

Funding overview

Funding rounds

Investors

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Polpharma Biologics