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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
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
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...
About the Company : Established in 1997, Nanogen Pharmaceutical Biotechnology JSC has been striving to become a world-class innovative biotechnology company in the pharmaceutical industry. We are pro...
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: ApprovedProduct Type: Large molecule
Sponsor: Sandoz B2B
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2024
Lead Product(s) : Etanercept
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Large molecule
Upfront Cash : Not Applicable
May 03, 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: Large molecule
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 : Large molecule
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: Undisclosed
Study Phase: Phase IProduct Type: Large molecule
Sponsor: 4P Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2022
Lead Product(s) : Etanercept
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : 4P Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Undisclosed
Product Type : Large molecule
Upfront Cash : Not Applicable
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: ApprovedProduct Type: Large molecule
Sponsor: Samsung Biologics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition April 20, 2022
Lead Product(s) : Etanercept
Therapeutic Area : Dermatology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Samsung Biologics
Deal Size : Undisclosed
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 : Large molecule
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: Immunology Brand Name: Benepali
Study Phase: ApprovedProduct Type: Large molecule
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 : Immunology
Highest Development Status : Approved
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 : Large molecule
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: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 23, 2021
Lead Product(s) : Etanercept
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Large molecule
Upfront Cash : Not Applicable
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: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2020
Lead Product(s) : Etanercept
Therapeutic Area : Dermatology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Large molecule
Upfront Cash : Not Applicable
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: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 27, 2020
Lead Product(s) : Etanercept
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Large molecule
Upfront Cash : Not Applicable
March 27, 2020
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