SteinCares Partners with Shilpa Biologicals on Latin America Biosimilar Deal – Regional Commercialization Agreement

SteinCares, a leading specialty healthcare company in Latin America, and Shilpa Biologicals Pvt. Ltd. (SBPL), a fully integrated biopharmaceutical subsidiary of Shilpa Medicare Limited (BOM: 530549, NSE: SHILPAMED), announced a strategic licensing agreement to commercialize a biosimilar across Latin America. The partnership combines SBPL’s biologics development and manufacturing expertise with SteinCares’ integrated regional commercial platform.

Transaction Overview

ItemDetail
Partner 1SteinCares (Latin America specialty healthcare)
Partner 2Shilpa Biologicals Pvt. Ltd. (SBPL), subsidiary of Shilpa Medicare (BOM: 530549, NSE: SHILPAMED)
Collaboration TypeStrategic licensing agreement
ProductBiosimilar (specific molecule undisclosed)
TerritoryLatin America (exclusive)
SteinCares RightsRegistration, commercialization, distribution
SBPL ResponsibilitiesProduct development + commercial manufacturing
Manufacturing SiteDharwad, India facility

Partnership Structure

FunctionResponsibilityLocation
DevelopmentSBPLIndia
ManufacturingSBPL – Dharwad facilityIndia
Regulatory RegistrationSteinCaresLatin America
CommercializationSteinCaresLatin America
DistributionSteinCaresLatin America

Strategic Rationale

  • Latin America Market Access: SteinCares’ established regional infrastructure provides SBPL with immediate market entry across diverse regulatory environments (Brazil, Mexico, Argentina, Colombia, etc.) without building proprietary commercial teams.
  • Manufacturing Cost Advantage: SBPL’s Indian manufacturing base offers cost‑competitive biosimilar production, critical for price‑sensitive Latin American healthcare systems and government procurement.
  • Risk Sharing: The development‑manufacturing / commercialization split aligns incentives—SBPL ensures product quality and supply; SteinCares drives market penetration and revenue generation.
  • Biosimilar Growth Trend: Latin America represents an emerging biosimilar market with increasing regulatory harmonization and payer acceptance; early partnerships secure first‑mover positioning.

Market Context

FactorImpact
Latin America Biosimilar MarketProjected double‑digit growth driven by healthcare cost containment and patent expiries of major biologics
SteinCares PositioningLeading specialty pharma platform with established relationships across hospitals, pharmacies, and government channels
Shilpa Medicare ExpansionBiosimilar partnership extends SBPL’s global footprint beyond India and established markets into high‑growth Latin America
Regulatory LandscapeANVISA (Brazil), COFEPRIS (Mexico) increasing biosimilar approval pathways; SteinCares’ regulatory expertise de‑risks market entry

Forward‑Looking Statements
This brief contains forward‑looking statements regarding product registration timelines, commercial launch dates, and market penetration expectations. Actual results may differ due to risks including regulatory approval delays, competitive biosimilar launches, and pricing pressure in Latin American markets.-Fineline Info & Tech