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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25698
Submission : 2011-12-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22163
Submission : 2008-10-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22163
Submission : 2008-10-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25698
Submission : 2011-12-30
Status : Inactive
Type : II
About the Company : BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies al...
About the Company : KinBio is a rapidly growing biopharmaceutical company based in Rehovot, Israel, with its main focus on developing needed therapies as well as offering a wide range of CDMO services...
Details:
The agreement, Blau’s most recent move into the biosimilars market, is a multi-product and multi-year deal to develop products and licenses IP for four biosimilar assets targeting indications in oncology, inflammation, and blood disorders.
Lead Product(s): Erythropoietin EPO
Therapeutic Area: Hematology Brand Name: rHuEPO
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Blau Farmaceutica
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 25, 2022
Lead Product(s) : Erythropoietin EPO
Therapeutic Area : Hematology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Blau Farmaceutica
Deal Size : Undisclosed
Deal Type : Partnership
Similis Bio Partners With Blau Farmaceutica to Co-Develop Four Biosimilar Programs
Details : The agreement, Blau’s most recent move into the biosimilars market, is a multi-product and multi-year deal to develop products and licenses IP for four biosimilar assets targeting indications in oncology, inflammation, and blood disorders.
Brand Name : rHuEPO
Molecule Type : Large molecule
Upfront Cash : Undisclosed
October 25, 2022
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Recormon Pre-Filled
Dosage Form : PFS
Dosage Strength : 4000iu
Packaging : 0.3X6iu
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Sweden
Brand Name : Epoetin alfa HEXAL
Dosage Form : INJEKTIONSVÄTSKA, LÖSNING, FÖRFYLLD SPRUTA
Dosage Strength : 9000 IE/ 0,9 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Eprex
Dosage Form : INJEKTIONSVÄTSKA, LÖSNING, FÖRFYLLD SPRUTA
Dosage Strength : 40 000 IE/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Eprex
Dosage Form : Inj L?s
Dosage Strength : 2000iu/0.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Eprex
Dosage Form : Inj L?s
Dosage Strength : 5000iu/0.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Eprex 10000
Dosage Form :
Dosage Strength :
Packaging : 6
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Eprex 40,000
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Sweden
Brand Name : Binocrit
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 9000 IU / 0.9 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Australia
Brand Name : Novicrit
Dosage Form :
Dosage Strength :
Packaging : 6
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Switzerland
Brand Name : EpoTheta-Teva
Dosage Form : Inj Solution
Dosage Strength : 20000U/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
RLD :
TE Code :
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 10,000U/ML
Approval Date :
Application Number : 103234
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; MULTIDOSE
Dosage Strength : 20,000U/2ML
Approval Date :
Application Number : 103234
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; MULTIDOSE
Dosage Strength : 20,000/ML
Approval Date :
Application Number : 103234
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 2,000U/ML
Approval Date :
Application Number : 103234
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 3,000U/ML
Approval Date :
Application Number : 103234
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 4,000U/ML
Approval Date :
Application Number : 103234
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : RETACRIT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2,000UNITS/ML
Approval Date :
Application Number : 125545
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : RETACRIT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 3,000UNITS/ML
Approval Date :
Application Number : 125545
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : RETACRIT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4,000UNITS/ML
Approval Date :
Application Number : 125545
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : RETACRIT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10,000UNITS/ML
Approval Date :
Application Number : 125545
RX/OTC/DISCN :
RLD :
TE Code :
Regulatory Info :
Registration Country : Sweden
Brand Name : Epoetin alfa HEXAL
Dosage Form : INJEKTIONSVÄTSKA, LÖSNING, FÖRFYLLD SPRUTA
Dosage Strength : 5000 IE/ 0,5 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Epoetin alfa HEXAL
Dosage Form : INJEKTIONSVÄTSKA, LÖSNING, FÖRFYLLD SPRUTA
Dosage Strength : 9000 IE/ 0,9 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Eprex
Dosage Form : INJEKTIONSVÄTSKA, LÖSNING
Dosage Strength : 4000 IE/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Eprex
Dosage Form : Inj Loose
Dosage Strength : 1000iu/0.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Eprex
Dosage Form : Inj L?s
Dosage Strength : 5000iu/0.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Binocrit
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 7000 IU / 0.7 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Binocrit
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 5000 IU / 0.5 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Binocrit
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 20 000 IU / 0.5 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Binocrit
Dosage Form : Inj Loose
Dosage Strength : 1000iu/0.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : EpoTheta-Teva
Dosage Form : Inj L?s
Dosage Strength : 5000iu/0.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Thailand
RECOMBINANT HUMAN ERYTHROPOIETIN
Brand Name : Hema-Plus
Dosage Form : Solution For Injection
Dosage Strength : 4000IU/1ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Thailand
Packaging :
Regulatory Info :
RECOMBINANT HUMAN ERYTHROPOIETIN
Dosage : Solution For Injection
Dosage Strength : 4000IU/1ML
Brand Name : Hema-Plus
Approval Date :
Application Number :
Registration Country : Thailand
Global Sales Information
Dosage Form : Inj L?s
Dosage Strength : 20000iu/0.5ml
Price Per Pack (Euro) : 159.93
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Inj L?s
Dosage Strength : 2000iu/0.5ml
Price Per Pack (Euro) : 95.96
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Inj L?s
Dosage Strength : 30000iu/0.75ml
Price Per Pack (Euro) : 239.91
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Inj L?s
Dosage Strength : 4000iu/0.4ml
Price Per Pack (Euro) : 191.93
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Inj L?s
Dosage Strength : 5000iu/0.5ml
Price Per Pack (Euro) : 239.91
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Inj L?s
Dosage Strength : 10000U/ml
Price Per Pack (Euro) : 436.08
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Inj L?s
Dosage Strength : 1000iu/0.5ml
Price Per Pack (Euro) : 45.86
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Inj L?s
Dosage Strength : 2000iu/0.5ml
Price Per Pack (Euro) : 91.73
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Inj L?s
Dosage Strength : 3000iu/0.5ml
Price Per Pack (Euro) : 137.6
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Inj L?s
Dosage Strength : 4000iu/0.5ml
Price Per Pack (Euro) : 183.47
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Main Therapeutic Indication : Hematology
Currency : USD
2019 Revenue in Millions : 270
2018 Revenue in Millions : 297
Growth (%) : -9
Main Therapeutic Indication : Hematology
Currency : USD
2020 Revenue in Millions : 598
2019 Revenue in Millions : 867
Growth (%) : -31
Main Therapeutic Indication : Hematology
Currency : USD
2021 Revenue in Millions : 521
2020 Revenue in Millions : 598
Growth (%) : -13
Main Therapeutic Indication : Hematology
Currency : USD
2020 Revenue in Millions : 266
2019 Revenue in Millions : 292
Growth (%) : -9
Main Therapeutic Indication : Hematology
Currency : USD
2020 Revenue in Millions : 552
2019 Revenue in Millions : 790
Growth (%) : -30
Main Therapeutic Indication : Hematology
Currency : USD
2021 Revenue in Millions : 479
2020 Revenue in Millions : 552
Growth (%) : -13
Main Therapeutic Indication : Hematology
Currency : USD
2022 Revenue in Millions : 506
2021 Revenue in Millions : 521
Growth (%) : -3
Main Therapeutic Indication : Blood Related Disorders
Currency : USD
2015 Revenue in Millions : 2,031
2014 Revenue in Millions : 1,856
Growth (%) : -9%
Main Therapeutic Indication : Blood Related Disorders
Currency : USD
2014 Revenue in Millions : -9.20%
2013 Revenue in Millions :
Growth (%) :
Main Therapeutic Indication : Blood Disorders
Currency : USD
2017 Revenue in Millions : 1,096
2016 Revenue in Millions : 1,282
Growth (%) : -15
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