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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
NDC Package Code : 63552-102
Start Marketing Date : 2003-01-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (25mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 63552-102
Start Marketing Date : 2003-01-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (25mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Details:
Rymti is an etanercept-biosimilar TNF blocker indicated for treating rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis.
Lead Product(s): Etanercept
Therapeutic Area: Immunology Brand Name: Rymti
Study Phase: Approved FDFProduct Type: Protein
Sponsor: Sandoz B2B
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 05, 2024
Lead Product(s) : Etanercept
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Sandoz B2B
Deal Size : Inapplicable
Deal Type : Inapplicable
Lupin Launches Rymti Biosimilar Etanercept in Canada
Details : Rymti is an etanercept-biosimilar TNF blocker indicated for treating rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis.
Product Name : Rymti
Product Type : Protein
Upfront Cash : Inapplicable
March 05, 2024
Details:
Under the agreement, Intas receives exclusive rights to commercialise Etanercept biosimilars, through its affiliates, for the treatment of various autoimmune diseases, in more than 150 countries across the globe, including Europe and the United States of America.
Lead Product(s): Etanercept
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Protein
Sponsor: Intas Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 20, 2023
Lead Product(s) : Etanercept
Therapeutic Area : Immunology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Intas Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Under the agreement, Intas receives exclusive rights to commercialise Etanercept biosimilars, through its affiliates, for the treatment of various autoimmune diseases, in more than 150 countries across the globe, including Europe and the United States of...
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Undisclosed
December 20, 2023
Details:
The NTM device was applied to the dorsal forearm and etanercept infused for 1.25 hours. The device was alternately applied between the left and right forearms every other week.
Lead Product(s): Etanercept
Therapeutic Area: Immunology Brand Name: Enbrel
Study Phase: Phase IProduct Type: Protein
Sponsor: 4P Therapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 26, 2022
Lead Product(s) : Etanercept
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : 4P Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The NTM device was applied to the dorsal forearm and etanercept infused for 1.25 hours. The device was alternately applied between the left and right forearms every other week.
Product Name : Enbrel
Product Type : Protein
Upfront Cash : Inapplicable
October 26, 2022
Details:
Upon the acquisition of Biogen’s equity stake, companies will continue their agreement, including commercialization of products BENEPALI (etanercept), a biosimilar of ENBREL, IMRALDITM (adalimumab), a biosimilar of Humira and FLIXABI (infliximab), a biosimilar of Remicade.
Lead Product(s): Etanercept
Therapeutic Area: Dermatology Brand Name: Benepali
Study Phase: Approved FDFProduct Type: Protein
Sponsor: Samsung Biologics
Deal Size: $2,300.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition April 20, 2022
Lead Product(s) : Etanercept
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Samsung Biologics
Deal Size : $2,300.0 million
Deal Type : Acquisition
Samsung Biologics Completes Full Acquisition of Samsung Bioepis
Details : Upon the acquisition of Biogen’s equity stake, companies will continue their agreement, including commercialization of products BENEPALI (etanercept), a biosimilar of ENBREL, IMRALDITM (adalimumab), a biosimilar of Humira and FLIXABI (infliximab), a bi...
Product Name : Benepali
Product Type : Protein
Upfront Cash : Undisclosed
April 20, 2022
Details:
Upon the acquisition of Biogen’s equity stake, companies will continue their agreement, including commercialization of products BENEPALI (etanercept), a biosimilar of ENBREL, IMRALDITM (adalimumab), a biosimilar of Humira and FLIXABI (infliximab), a biosimilar of Remicade.
Lead Product(s): Etanercept
Therapeutic Area: Dermatology Brand Name: Benepali
Study Phase: Approved FDFProduct Type: Protein
Sponsor: Samsung Biologics
Deal Size: $2,350.0 million Upfront Cash: $1,000.0 million
Deal Type: Divestment January 27, 2022
Lead Product(s) : Etanercept
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Samsung Biologics
Deal Size : $2,350.0 million
Deal Type : Divestment
Details : Upon the acquisition of Biogen’s equity stake, companies will continue their agreement, including commercialization of products BENEPALI (etanercept), a biosimilar of ENBREL, IMRALDITM (adalimumab), a biosimilar of Humira and FLIXABI (infliximab), a bi...
Product Name : Benepali
Product Type : Protein
Upfront Cash : $1,000.0 million
January 27, 2022
Details:
The first patient treated with Sofusa with Enbrel achieved a dramatic improvement in disease activity in just 12 weeks receiving only 50% of the Enbrel subcutaneous dose weekly.
Lead Product(s): Etanercept
Therapeutic Area: Immunology Brand Name: Enbrel
Study Phase: Phase IProduct Type: Protein
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 23, 2021
Lead Product(s) : Etanercept
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sorrento Publishes Positive Initial Results of SOFUSA® Lymphatic Drug Delivery System in a Phase ...
Details : The first patient treated with Sofusa with Enbrel achieved a dramatic improvement in disease activity in just 12 weeks receiving only 50% of the Enbrel subcutaneous dose weekly.
Product Name : Enbrel
Product Type : Protein
Upfront Cash : Inapplicable
August 23, 2021
Details:
BRENZYS® is a type of protein called a tumour necrosis factor (TNF) blocker that blocks the action of TNF-alpha, an Inflammatory cytokine which is over produced in people suffering from Plaque Psoriasis (PsO).
Lead Product(s): Etanercept
Therapeutic Area: Dermatology Brand Name: Brenzys
Study Phase: Approved FDFProduct Type: Protein
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 15, 2020
Lead Product(s) : Etanercept
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Health Canada approves Merck’s etanercept biosimilar for new indications
Details : BRENZYS® is a type of protein called a tumour necrosis factor (TNF) blocker that blocks the action of TNF-alpha, an Inflammatory cytokine which is over produced in people suffering from Plaque Psoriasis (PsO).
Product Name : Brenzys
Product Type : Protein
Upfront Cash : Inapplicable
September 15, 2020
Details:
The positive CHMP opinion is based on a biosimilarity assessment which included preclinical and clinical studies demonstrating bioequivalence to the reference product.
Lead Product(s): Etanercept
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Protein
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 27, 2020
Lead Product(s) : Etanercept
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mylan and Lupin Announce Positive CHMP Opinion for Nepexto®, Biosimilar Etanercept
Details : The positive CHMP opinion is based on a biosimilarity assessment which included preclinical and clinical studies demonstrating bioequivalence to the reference product.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
March 27, 2020
Regulatory Info :
Registration Country : Australia
Brand Name : Brenzys
Dosage Form :
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Packaging : 1
Approval Date :
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Brenzys
Dosage Form :
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Brenzys
Dosage Form :
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Brenzys
Dosage Form :
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Brenzys
Dosage Form :
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Packaging : 1
Approval Date :
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Brenzys
Dosage Form :
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Enbrel
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Enbrel
Dosage Form :
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Packaging : 1
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Sweden
Brand Name : Enbrel
Dosage Form : PULVER OCH VÄTSKA TILL INJEKTIONSVÄTSKA
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Enbrel
Dosage Form : Inj. Soluble
Dosage Strength : 25mg/0.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
RLD :
TE Code :
Brand Name : ENBREL
Dosage Form : VIAL; SUBCUTANEOUS
Dosage Strength : 25MG/VIAL
Approval Date :
Application Number : 103795
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
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Brand Name : ENBREL
Dosage Form : SYRINGE
Dosage Strength : 50MG/ML
Approval Date :
Application Number : 103795
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
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Brand Name : ETICOVO
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 25MG/0.5ML
Approval Date :
Application Number : 761066
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
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Brand Name : ETICOVO
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MG/1ML
Approval Date :
Application Number : 761066
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
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Brand Name : ERELZI
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 25MG/0.5ML
Approval Date :
Application Number : 761042
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : ERELZI
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 50MG/ML
Approval Date :
Application Number : 761042
RX/OTC/DISCN :
RLD :
TE Code :
Regulatory Info :
Registration Country : Sweden
Brand Name : Enbrel
Dosage Form : INJEKTIONSVÄTSKA, LÖSNING I FÖRFYLLD
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Enbrel
Dosage Form : PULVER OCH VÄTSKA TILL INJEKTIONSVÄTSKA
Dosage Strength : 25 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Enbrel
Dosage Form : PULVER OCH VÄTSKA TILL INJEKTIONSVÄTSKA
Dosage Strength : 10 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Enbrel
Dosage Form : PULVER OCH VÄTSKA TILL INJEKTIONSVÄTSKA
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Enbrel
Dosage Form : PULVER OCH VÄTSKA TILL INJEKTIONSVÄTSKA
Dosage Strength : 25 MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Enbrel
Dosage Form : Inj Solution
Dosage Strength : 50mg/ml
Packaging :
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Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Enbrel MyClic
Dosage Form : Inj L?s
Dosage Strength : 50mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Benepali
Dosage Form : Inj L?s
Dosage Strength : 50mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Benepali
Dosage Form : Inj Sol
Dosage Strength : 50mg/ml
Packaging :
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Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Benepali
Dosage Form : Inj L?s
Dosage Strength : 25mg/0.5ml
Packaging :
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Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ENBREL
Dosage Form : SOLUTION
Dosage Strength : 50MG/ML
Packaging : 0.98ML
Approval Date :
Application Number : 2274728
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : RYMTI
Dosage Form : SOLUTION
Dosage Strength : 50MG/1ML
Packaging :
Approval Date :
Application Number : 2530295
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : RYMTI
Dosage Form : SOLUTION
Dosage Strength : 50MG/1ML
Packaging :
Approval Date :
Application Number : 2530309
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : BRENZYS
Dosage Form : SOLUTION
Dosage Strength : 50MG/ML
Packaging :
Approval Date :
Application Number : 2455323
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : BRENZYS
Dosage Form : SOLUTION
Dosage Strength : 50MG/ML
Packaging :
Approval Date :
Application Number : 2455331
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ERELZI
Dosage Form : SOLUTION
Dosage Strength : 50MG/ML
Packaging : 1/2/4/12 PENS
Approval Date :
Application Number : 2462850
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ERELZI
Dosage Form : SOLUTION
Dosage Strength : 50MG/ML
Packaging : 1/2/4/12 PFS
Approval Date :
Application Number : 2462869
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ERELZI
Dosage Form : SOLUTION
Dosage Strength : 25MG/0.5ML
Packaging : 0.5ML
Approval Date :
Application Number : 2462877
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Brenzys
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Brenzys
Dosage Form :
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Brenzys
Dosage Form :
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Packaging : 1
Approval Date :
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Enbrel
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Enbrel
Dosage Form :
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Packaging : 1
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Enbrel
Dosage Form :
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Enbrel
Dosage Form :
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Packaging : 1
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Enbrel
Dosage Form :
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Enbrel
Dosage Form :
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Enbrel
Dosage Form :
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Iran
Brand Name : Altebrel
Dosage Form : Injectable
Dosage Strength : 25MG
Packaging : PFS
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging : PFS
Regulatory Info :
Dosage : Injectable
Dosage Strength : 25MG
Brand Name : Altebrel
Approval Date :
Application Number :
Registration Country : Iran
Regulatory Info :
Registration Country : Iran
Brand Name : Altebrel
Dosage Form : Injectable
Dosage Strength : 50MG
Packaging : PFS
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging : PFS
Regulatory Info :
Dosage : Injectable
Dosage Strength : 50MG
Brand Name : Altebrel
Approval Date :
Application Number :
Registration Country : Iran
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