
Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target

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Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Study Phase : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Calliditas’ STADA Receives EC Decision for Full Approval of Kinpeygo® in IgA Nephropathy
Details : Kinpeygo (budesonide)is a modified-release capsule, glucocorticoid receptor agonist, which is indicated for the treatment of patients with primary IgA nephropathy.
Product Name : Kinpeygo
Product Type : Steroid
Upfront Cash : Inapplicable
July 26, 2024
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Ustekinumab
Therapeutic Area : Immunology
Study Phase : Approved FDF
Sponsor : Alvotech
Deal Size : Inapplicable
Deal Type : Inapplicable
STADA and Alvotech Launch Uzpruvo, First Ustekinumab Biosimilar to Stelara in Europe
Details : Uzpruvo (ustekinumab-biosimilar) is a human IgG1κ monoclonal antibody (mAb) which inhibits IL-12 & Il-23. It is approved by EMA for the treatment of crohn’s disease, psoriasis and psoriatic arthritis.
Product Name : Uzpruvo
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
July 22, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Sponsor : Alvotech
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Recipient : Alvotech
Deal Size : Undisclosed
Deal Type : Partnership
Alvotech and STADA Add to Strategic Alliance Through Denosumab Partnership
Details : The partnership aims to cover AVT03, a clinical-stage biosimilar candidate referencing the Prolia®/Xgeva® (denosumab) medicines for osteoporosis and cancer-related bone loss respectively.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Undisclosed
June 11, 2024
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Recipient : Alvotech
Deal Size : Undisclosed
Deal Type : Partnership

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Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Recipient : Bio-Thera Solutions
Deal Size : $157.5 million
Deal Type : Licensing Agreement
Bio-Thera and STADA Reach Agreement for BAT2506 Biosimilar in the EU and UK
Details : Under the agreement, Bio-Thera Solutions will maintain responsibility for development, manufacturing, and supply of BAT2506, a biosimilar candidate to Simponi® (golimumab).
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : $10.0 million
May 28, 2024
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Recipient : Bio-Thera Solutions
Deal Size : $157.5 million
Deal Type : Licensing Agreement

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Lead Product(s) : Ustekinumab
Therapeutic Area : Immunology
Study Phase : Approved FDF
Sponsor : Alvotech
Deal Size : Inapplicable
Deal Type : Inapplicable
STADA and Alvotech Secure Approval for Uzpruvo, Europe's First Ustekinumab Biosimilar
Details : Uzpruvo (ustekinumab-biosimilar) is a human IgG1κ monoclonal antibody (mAb) which inhibits IL-12 & Il-23. It is approved by EMA for the treatment of crohn’s disease, psoriasis and psoriatic arthritis.
Product Name : Uzpruvo
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
January 10, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Sponsor : Alvotech
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Uzpruvo (ustekinumab) biosimilar candidate to Stelara is a human IgG1κ monoclonal antibody (mAb), which is investigated for the treatment of moderate to severe chronic plaque-type psoriasis.
Product Name : Uzpruvo
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
November 10, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Approved FDF
Sponsor : Xbrane Biopharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Stada and Xbrane Obtain British Approval for Ximluci® (ranibizumab) Biosimilar Referencing Lucentis®
Details : Ximluci (ranibizumab) binds and inhibits VEGF-A, including VEGF110, preventing the interaction of VEGF-A with VEGFR1 and VEGFR2 on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation...
Product Name : Ximluci
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
January 16, 2023
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Sponsor : Xbrane Biopharma
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Study Phase : Approved FDF
Recipient : Alvotech
Deal Size : Inapplicable
Deal Type : Inapplicable
Alvotech and STADA Broaden Access to Hukyndra® Adalimumab Biosimilar in Europe
Details : Hukyndra (adalimumab) is a monoclonal antibody and a biosimilar to Humira® (adalimumab) that inhibits tumor necrosis factor. Adalimumab is first product launched through an exclusive strategic partnership announced by Alvotech and STADA in November 2019...
Product Name : Hukyndra
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
December 07, 2022
Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Recipient : Alvotech
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Adalimumab
Therapeutic Area : Immunology
Study Phase : Approved FDF
Recipient : Alvotech
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Hukyndra (adalimumab), Hukyndra is a monoclonal antibody and a biosimilar to Humira® (adalimumab) that inhibits tumor necrosis factor, increases availability of high-concentration, low-volume, citrate-free presentations of adalimumab.
Product Name : Hukyndra
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
September 22, 2022
Lead Product(s) : Adalimumab
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Recipient : Alvotech
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Study Phase : Approved FDF
Sponsor : Calliditas Therapeutics AB
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Nefecon (budesonide) is a patented novel, investigational oral formulation of a potent and well-known active substance – budesonide – for targeted release. The formulation is designed to deliver the drug to the ileum where the Peyer’s patches are c...
Product Name : Nefecon
Product Type : Steroid
Upfront Cash : Inapplicable
September 20, 2022
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Sponsor : Calliditas Therapeutics AB
Deal Size : Inapplicable
Deal Type : Inapplicable
