Kashiv BioSciences
Kashiv BioSciences is a vertically integrated biopharmaceutical company that develops and manufactures biosimilars and complex peptide-based medicines, currently with two FDA-approved oncology supportive care biosimilars (Releuko, Fylnetra), a multi-asset global pipeline, and exclusive licensing partnerships covering US, Europe, Canada, Latin America, MENA, and Mexico/CAC regions.
- Company typePrivate
- Founded2011
- HeadquartersPiscataway, United States
- Headcount501–1,000
- GTM typeB2B
- OfferingHardware or Manufacturing
What Kashiv BioSciences does
Kashiv BioSciences is a vertically integrated biopharmaceutical company founded in 2011 and headquartered in Bridgewater, New Jersey, with operating facilities in Piscataway, New Jersey (150,000 sq.ft.), Chicago, Illinois (100,000 sq.ft.), Ahmedabad, India (125,000 sq.ft.), and a new facility under construction in Pipan, Gujarat, India. The company develops and manufactures biosimilars and complex peptide-based medicines, with capabilities spanning mammalian cell line development, microbial fermentation, analytical characterization, bioassay development, and fill-finish for prefilled syringes and vials. Its commercialized product portfolio includes two FDA-approved biosimilars — Releuko (filgrastim-ayow) and FYLNETRA (pegfilgrastim-pbbk) — for oncology supportive care, with later-stage pipeline assets including ADL-018 (omalizumab biosimilar with pending BLA/MAA across FDA, EMA, MHRA, and Health Canada), KSHB002 (abatacept biosimilar, Phase 1), undisclosed biosimilar candidates KSHB001 and KSHB011, a 505(b)(2) Carfilzomib program, and generic complex peptide programs KSHG004, KSHG005, and KSHG006.
Kashiv employs 600+ people globally, with over half holding advanced degrees, and operates through exclusive licensing and supply agreements with regional commercialization partners across the U.S. (Amneal), Europe/UK/India (Intas/Accord Healthcare), Canada (JAMP Pharma), Latin America (CRISTÁLIA), MENA (MS Pharma), and Mexico/Central America and Caribbean (Saya Biologics). Under this asset-light commercialization model, Kashiv handles regulatory registration, manufacturing, and supply while partners manage local sales, marketing, and distribution. Revenue streams include transaction-based product sales, licensing royalties/supply agreements, and contract manufacturing, with biosimilars sold at substantial discounts to originator biologics whose list prices typically exceed $100,000 per patient per year.
The company secured $150 million in debt financing from GoldenTree Asset Management in April 2025 and INR 648 crore (~$77 million) from Union Bank of India in December 2025 to fund capacity expansion including a 50,000-liter single-use commercial manufacturing facility in Pipan. In April 2026, Amneal Pharmaceuticals entered a definitive agreement to acquire Kashiv for up to $1.1 billion ($375M cash, $375M equity, up to $350M milestones), expected to close in H2 2026, creating a fully integrated global biosimilars platform.
Kashiv BioSciences firmographics
Firmographics- Name
- Kashiv BioSciences
- Legal name
- Kashiv BioSciences, LLC
- Website
- https://kashivbiosciences.com
- Company type
- Private
- Founded year
- 2011
- Operating status
- Operating
- Headcount range
- 501–1,000 employees
- Short description
- Kashiv BioSciences is a vertically integrated biopharmaceutical company that develops and manufactures biosimilars and complex peptide-based medicines, currently with two FDA-approved oncology supportive care biosimilars (Releuko, Fylnetra), a multi-asset global pipeline, and exclusive licensing partnerships covering US, Europe, Canada, Latin America, MENA, and Mexico/CAC regions.
- Ownership category
- akta.pro rank
Kashiv BioSciences industry classification
Industry- Product category
- Biosimilar Pharmaceuticals
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412)
- SIC
- Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Automation, Controls & Manufacturing Execution for Bioprocessing (SCADA/DCS/PLC/MES) (HLAAAJAE)
Keywords
Where Kashiv BioSciences is headquartered
LocationHeadquarters
- HQ city
- Piscataway
- HQ country
- United States
- HQ region
- North America
Offices5 records
Markets served
Kashiv BioSciences business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Supply Chain, Infrastructure, Operations
Revenue model
- Biosimilar Product Sales: Revenue from commercialized biosimilar products including Releuko (filgrastim) and Fylnetra (pegfilgrastim) sold through distribution partners in the U.S. and international markets
- Licensing and Supply Agreements: Revenue from exclusive licensing and supply agreements with regional commercialization partners for biosimilars and complex peptide products. Kashiv handles regulatory registration, manufacturing, and supply while partners manage commercialization and distribution.
- Contract Manufacturing: Manufacturing capabilities for biologics and specialty pharmaceuticals serving both internal pipeline products and potentially external partners
Go-to-market motion2 records
Distribution channels2 records
Marketing channels4 records
Kashiv BioSciences product offering
Product offeringCore offering
Kashiv BioSciences is a fully integrated biopharmaceutical company that develops, manufactures, and commercializes biosimilars, complex generics, and peptide-based medicines. It operates vertically integrated capabilities spanning cell line development, bioassay development, analytical characterization, commercial-scale mammalian and microbial manufacturing, and fill-finish operations for prefilled syringes and vials. Its commercialized products include FDA-approved biosimilars Releuko (filgrastim-ayow) and FYLNETRA (pegfilgrastim-pbbk), with a pipeline targeting immunology, oncology supportive care, and respiratory indications.
Product overview
Kashiv BioSciences is a fully-integrated biopharmaceutical company developing biosimilars, complex generics, and peptide-based medicines. The product portfolio includes FDA-approved biosimilars Releuko (filgrastim-ayow) and FYLNETRA (pegfilgrastim-pbbk) for oncology supportive care, and a growing pipeline of biosimilar candidates including ADL-018 (omalizumab biosimilar with FDA, EMA, MHRA, and Health Canada submissions), KSHB002 (abatacept biosimilar), and undisclosed candidates KSHB011 and KSHB001. The company also develops complex medicines via 505(b)(2) and ANDA pathways, including Carfilzomib and peptide programs KSHG004, KSHG005, and KSHG006. Products are manufactured across integrated facilities in the US (New Jersey, Chicago) and India (Ahmedabad, Pipan).
Differentiator
Problem solved
Functional benefit
Brands
- Releuko: FDA-approved biosimilar (filgrastim-ayow) for oncology supportive care
- FYLNETRA
- PEXEGRA
- FILRA
Products and services
- Releuko (filgrastim-ayow) FDA-approved biosimilar providing filgrastim therapy to reduce infection risk in patients undergoing chemotherapy; sold through commercial partnerships in the U.S. market.
- FYLNETRA (pegfilgrastim-pbbk) FDA-approved biosimilar providing long-acting pegfilgrastim therapy to reduce febrile neutropenia risk in chemotherapy patients; commercialized in the U.S. via Amneal.
- ADL-018 (Omalizumab biosimilar) Biosimilar candidate to XOLAIR (omalizumab) for immunology and respiratory indications, with BLA filed at FDA, MAA accepted by EMA, validated by MHRA UK, and accepted by Health Canada.
- PEXEGRA Health Canada approved biosimilar commercialized in Canada through distribution partnership with JAMP Pharma Corporation.
- FILRA Health Canada approved biosimilar commercialized in Canada through distribution partnership with JAMP Pharma Corporation.
- KSHB002 (Abatacept biosimilar) Biosimilar candidate referencing Orencia (abatacept) for immunology indications; Phase 1 clinical results announced in January 2026.
- Carfilzomib Oncology therapeutic candidate developed via the 505(b)(2) regulatory pathway, currently in development phase.
- KSHG004 Fertility peptide candidate in advanced development and filing stage under the generic peptide program.
- KSHG005 Fertility peptide candidate in advanced development and filing stage under the generic peptide program.
- KSHG006 Oncology and hormonal peptide candidate in development for FDA filing under the generic peptide program.
Quantifiable outcome
- Up to $150 billion in potential US biosimilar cost savings by 2026
- +3 more outcomes
Companies that use Kashiv BioSciences
Customer profileNamed customers5 records
Segments3 records
Ideal customer profiles2 records
Kashiv BioSciences technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Kashiv BioSciences partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered flagship, core and regional.
- Amneal PharmaceuticalsflagshipDefinitive agreement for Amneal to acquire Kashiv BioSciences for $1.1 billion ($375M cash, $375M equity, up to $350M milestones). Creates fully integrated global biosimilars platform combining Kashiv's R&D, manufacturing, and regulatory capabilities with Amneal's commercial scale and distribution network. Expected to close H2 2026 pending shareholder approval and regulatory clearances.
- Intas Pharmaceuticals / Accord HealthcarecoreExclusive licensing and supply agreement for complex peptide product covering pan-European, UK, and Indian markets. Kashiv handles regulatory registration, manufacturing, and supply while Accord Healthcare manages commercialization and distribution.
- Saya BiologicscoreStrategic partnership to register and commercialize a biosimilar supportive oncology therapy across Mexico and Central America and Caribbean (CAC) region covering 11 countries. Saya handles regulatory registration, commercialization, and distribution while Kashiv manages manufacturing and supply.
- JAMP Pharma CorporationcoreLaunch partnership for PEXEGRA and FILRA biosimilars in Canada. JAMP handles commercialization and distribution in Canadian market.
- CRISTÁLIAregionalLicensing and supply agreement for omalizumab biosimilar (ADL-018) in Latin America markets.
- MS PharmaregionalMENA license and supply agreement for ADL-018, biosimilar candidate to Xolair (omalizumab).
- Amneal PharmaceuticalscoreExclusive licensing agreement for commercialization of proposed biosimilar to Xolair (omalizumab) in US market.
- AlvotechcoreExclusive licensing agreement for development and commercialization of proposed biosimilar to Xolair (omalizumab). Subsequent termination with Amneal partnership replacing this arrangement.
Scale indicators10 records
Recent moves8 records
Expansion highlights6 records
Kashiv BioSciences competitors and assessment
Company assessmentDirect peers
- Alvotech: Pure-play biosimilar developer and manufacturer with a portfolio that includes an omalizumab biosimilar candidate — the same reference product as Kashiv's ADL-018. Alvotech and Kashiv previously had a co-development/licensing partnership on the omalizumab program that was later terminated, making them a directly comparable peer on pipeline, scale, and go-to-market model.
- Biocon Biologics: India-headquartered, fully integrated biosimilars developer and manufacturer with FDA/EMA-approved products across oncology, immunology, and diabetes. Kashiv's SVP Regulatory Affairs previously led Biocon's global biopharma regulatory function, and the companies compete head-to-head on mAb biosimilars and complex biologics manufacturing capacity in India.
- Celltrion: Korean biosimilar pioneer with multiple EMA/FDA-approved biosimilars (Remsima/Inflectra, Truxima, Herzuma, etc.) and a vertically integrated manufacturing platform. Celltrion is a direct benchmark for Kashiv's vertically integrated biosimilar business model and competes in many of the same reference molecules (rituximab, trastuzumab, etc.).
- Samsung Bioepis: Joint venture between Samsung Biologics and Biogen developing and commercializing biosimilars across oncology, immunology, and ophthalmology. Directly comparable to Kashiv as a focused biosimilar developer leveraging a large-scale biologics manufacturing platform.
- Coherus BioSciences: U.S.-headquartered commercial-stage biosimilar company with approved products in oncology supportive care and a pipeline in ophthalmology and immunology. Highly comparable to Kashiv on U.S. commercial strategy, pipeline composition, and capital-markets profile.
- Enzene Biosciences: India-based biologics CDMO and biosimilar developer focused on biosimilars and complex biologics with mammalian and microbial manufacturing capabilities. Closely comparable to Kashiv's India-based biologics manufacturing strategy, including its Pipan expansion in Gujarat.
- Polpharma Biologics: European biosimilar developer and manufacturer with commercial-stage biosimilars across oncology and immunology, plus its own GMP manufacturing. Comparable to Kashiv on integrated development-and-manufacturing model targeting the same Western and emerging-market biosimilar opportunities.
Broad incumbents
- Sandoz: Novartis spin-off and global leader in generics and biosimilars with a broad portfolio of FDA/EMA-approved biosimilars and extensive in-house biologics manufacturing. Kashiv's SVP Regulatory previously led U.S. regulatory affairs at Sandoz; Sandoz serves as the incumbent benchmark for the addressable market Kashiv targets.
- Amneal Pharmaceuticals: U.S. generic and specialty pharmaceutical company that has signed a definitive agreement to acquire Kashiv for up to $1.1B. Amneal is the broader incumbent generic-pharma platform that Kashiv's biosimilar assets are being integrated into, and overlaps with Kashiv on the Xolair biosimilar commercialization partnership.
- Teva Pharmaceutical Industries: Global generic and biosimilar pharmaceutical major with multiple FDA/EMA-approved biosimilars. Teva's broad biosimilar and generics portfolio represents the incumbent competitive landscape Kashiv competes within as it scales its partner-driven global commercialization model.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Kashiv BioSciences social profiles
Digital presenceKashiv BioSciences compliance and trust
Trust signalCompliance2 records
Kashiv BioSciences financial estimates
Financial estimateRevenue estimate
Valuation estimate
Kashiv BioSciences leadership team
Management profileNumber of profiles
Profiles12 records
Kashiv BioSciences subsidiaries and ownership
Company hierarchySubsidiaries1 record
Kashiv BioSciences funding detail
Funding detailFunding overview
Funding rounds3 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Kashiv BioSciences M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Kashiv BioSciences
What does Kashiv BioSciences do?
Kashiv BioSciences is a fully integrated biopharmaceutical company that develops, manufactures, and commercializes biosimilars, complex generics, and peptide-based medicines. It operates vertically integrated capabilities spanning cell line development, bioassay development, analytical characterization, commercial-scale mammalian and microbial manufacturing, and fill-finish operations for prefilled syringes and vials. Its commercialized products include FDA-approved biosimilars Releuko (filgrastim-ayow) and FYLNETRA (pegfilgrastim-pbbk), with a pipeline targeting immunology, oncology supportive care, and respiratory indications.
Is Kashiv BioSciences a public or private company?
Kashiv BioSciences is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Kashiv BioSciences founded?
Kashiv BioSciences was founded in 2011. It employs 501 to 1,000 people.
Where is Kashiv BioSciences based?
Kashiv BioSciences is headquartered in Piscataway, United States, in the North America region.
How does Kashiv BioSciences make money?
Three revenue lines are on record. Biosimilar Product Sales are the primary driver. The others are licensing and Supply Agreements and contract Manufacturing.
Who are Kashiv BioSciences's main competitors?
Direct peers on record are Alvotech, Biocon Biologics, Celltrion, Samsung Bioepis, Coherus BioSciences, Enzene Biosciences and Polpharma Biologics. Broad incumbents are Sandoz, Amneal Pharmaceuticals and Teva Pharmaceutical Industries.
Does Kashiv BioSciences have an API?
No public API is recorded for Kashiv BioSciences.
What industry is Kashiv BioSciences in?
Kashiv BioSciences's product category is Biosimilar Pharmaceuticals. Its primary akta.pro industry code is HLAAAJAE, Automation, Controls & Manufacturing Execution for Bioprocessing (SCADA/DCS/PLC/MES). Its NAICS code is 325414 and its SIC code is 2836.