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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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VMF

NDC API

API REF. PRICE (USD/KG)

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MARKET PLACE

0INTERMEDIATES

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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PATENTS & EXCLUSIVITIES

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US Patents

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US Exclusivities

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DIGITAL CONTENT

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Stock Recap #PipelineProspector

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GLOBAL SALES INFORMATION

US Medicaid

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5 RELATED EXCIPIENT COMPANIES

9EXCIPIENTS BY APPLICATIONS

Chemistry

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API SUPPLIERS

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01

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Biotech Digital Meet
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Flag U.S.A
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
LGM Pharma CB

02

Nanogen Pharmaceutical Biotechnolo...

Vietnam

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Biotech Digital Meet
Not Confirmed
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03

KinBio

Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Biotech Digital Meet
Not Confirmed
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KinBio

Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Biotech Digital Meet
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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NDC API

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01

Biotech Digital Meet
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ETANERCEPT

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

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Listed Suppliers

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01

LGM Pharma

U.S.A
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Biotech Digital Meet
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Flag U.S.A
Digital Content Digital Content

Etanercept

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, ...

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, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

02

KinBio

Israel
Biotech Digital Meet
Not Confirmed
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KinBio

Israel
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Not Confirmed

Etanercept

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...

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 – from concept to product. KinBio’s main focus is to pursue opportunities in the global pharmaceutical market. Augmented by a global group of affiliated companies, Kinbio specializes in research, development, manufacturing and commercialization of biopharmaceutical products. Kinbio’s commitment to top standard quality is inherent across the entire global organization, from our FDA approved cGMP sites to our state of the art R&D laboratories.
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03

Biotech Digital Meet
Not Confirmed
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Etanercept

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...

Established in 1997, Nanogen Pharmaceutical Biotechnology JSC has been striving to become a world-class innovative biotechnology company in the pharmaceutical industry. We are proud to be the leading company in the Asia-Pacific region that successfully researched and developed Active Pharmaceutical Ingredients (APIs) and specific therapeutic products on the foundation of advanced recombinant DNA/protein technology.
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Drugs in Development

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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

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01

Lupin Ltd

India
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Lupin Ltd

India
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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

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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

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02

Mabxience

Spain
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Biotech Digital Meet
Not Confirmed

Mabxience

Spain
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Not Confirmed

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

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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

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03

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
Not Confirmed

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

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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

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04

Samsung Bioepis

South Korea
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Biotech Digital Meet
Not Confirmed

Samsung Bioepis

South Korea
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Not Confirmed

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

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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

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Biogen

U.S.A
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Biotech Digital Meet
Not Confirmed

Biogen

U.S.A
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Biotech Digital Meet
Not Confirmed

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

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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

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06

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
Not Confirmed

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

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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

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07

Merck & Co

U.S.A
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Biotech Digital Meet
Not Confirmed

Merck & Co

U.S.A
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Not Confirmed

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

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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

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08

Viatris

U.S.A
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Biotech Digital Meet
Not Confirmed

Viatris

U.S.A
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Not Confirmed

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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