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CLINICALLY PROVEN | EUROPEAN DRUG SUBSTANCE

The biologics market is growing rapidly and during the next 5 years several biologics that have sales of more than $1 billion annually are scheduled to come off patent, providing the opportunity and incentive for biosimilar entry.

The development and manufacture of biosimilars are more complex compared to generics. the manufacturing complexity in each step involves a high degree of variability and hundreds of controlling input parameters, for safety and efficacy. Hence robust manufacturing, supply chain management and experience of the pharmaceutical manufacturer play a critical role.

Xeina Drugs offers high quality biosimilars with clinically proven biosimilarity, human clinical trial testing and comparative clinical trials for licensing to well established pharmaceuticals companies with the wherewithal to register and successfully market products of such high specialization.

Why license Biosimilars from Xeina Drugs
  • Novel drugs portfolio, first entry biosimilars
  • European Drug Substance and selected Drug products
  • Human clinical trials, comparative trials and biosimilarity
  • Open for FDF supply, API supply and full process technology transfer

BIOSIMILARS

GLATIRAMER ACETATE

  • Established Biosimilarity against reference drug through extensive analytical characterization proving structural and functional conformity
  • Toxicity studies, pre-clinical studies available
  • Phase III comparative clinical studies completed with proven efficacy and safety
  • ANDA filing planned for Q4 2019
  • Available as: Glatiramer Acetate 20 mg Pre filled Syringe (28 vials pack), 40 mg PFS under development
  • Available for Drug Product supply (FDF), Drug Substance supply (API as a fill finish form), full process technology transfer

RITUXIMAB

  • Established Biosimilarity against reference drug through extensive analytical characterization proving structural and functional conformity
  • Toxicity studies, pre-clinical studies available
  • Phase III comparative clinical studies completed with proven efficacy and safety
  • Available as: Rituximab for intravenous use: 100 mg/10 mL (2 vials pack); Rituximab 500 mg/50 mL (single vial);
  • Rituximab 1400 mg under development, Rituximab for sub cutaneous use under development
  • Available for Drug Product supply (FDF), Drug Substance supply (API as a fill finish form), full process technology transfer

ETANERCEPT

  • Established Biosimilarity against reference drug through extensive analytical characterization proving structural and functional conformity
  • Toxicity studies, pre-clinical studies available
  • Phase III comparative clinical studies completed with proven efficacy and safety
  • Available as: Etanercept 25mg: 4 1-mL vials with 4 PFS w/solvent and vial adapters; Etanercept 50mg: 2 1-mLvials with 2 PFS w/solvent and vial adapters
  • Available for Drug Product supply (FDF), Drug Substance supply (API as a fill finish form), full process technology transfer

INTERFERON BETA 1 A

  • Full EU CTD dossier available
  • 44 µg (12 million IU), 1 lyophilized vial or 1 PFS, .5ml
  • Open for tech transfer, FDF supply, fill finish supply

ERYTHROPOETIN

  • Clinical trials available, full EU CTD dossier available
  • 2000 IU, 12 lyophilized vial, 1ml
  • 4000 IU, 6 PFS
  • 50000 IU, 1 lyophilized vial, 1ml w/solvent
  • Open for tech transfer, FDF supply, fill finish supply

FILGRASTIM

  • Clinical trials available, full EU CTD dossier available
  • 300 μg, 5 vials or PFS
  • Open for tech transfer, FDF supply, fill finish supply

INFLIXIMAB

  • Commercial scale technology completed
  • Established Biosimilarity against reference drug through extensive analytical characterization proving structural and functional conformity
  • Toxicity studies, pre-clinical studies available
  • Available for technology transfer and drug substance (fill finish API) supply

ADALIMUMAB

  • Commercial scale technology completed
  • Established Biosimilarity against reference drug through extensive analytical characterization proving structural and functional conformity
  • Toxicity studies, pre-clinical studies available
  • Phase III, Global comparative trial (>500 patients) to be initiated by Q3 2019
  • Available for technology transfer and drug substance (fill finish API) supply

TRASTUZUMAB

  • Commercial scale technology completed
  • Established Biosimilarity against reference drug through extensive analytical characterization proving structural and functional conformity
  • Toxicity studies, pre-clinical studies available
  • Available for technology transfer and drug substance (fill finish API) supply

BEVACIZUMAB

  • Commercial scale technology completed
  • Established Biosimilarity against reference drug through extensive analytical characterization proving structural and functional conformity
  • Toxicity studies, pre-clinical studies available
  • Available for technology transfer and drug substance (fill finish API) supply

DENOSUMAB

  • Established Biosimilarity against reference drug through extensive analytical characterization proving structural and functional conformity
  • Commercial scale technology to be completed by Q4 2019

* Patent evaluation in respective country’s to be done by the clients.

Novel therapies and some of the latest monoclonal antibodies for oncology like nivolumab and pembrolizumab are in advanced stages of development.

RELATED LINKS - XEINA DRUGS PRODUCT PORTFOLIO:
Finished Dosage Formulations  |  Biosimilars  |  Specialized Products  |  Facial Aesthetics