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NEWS #PharmaBuzz
17 Feb 2026
// FIERCE PHARMA
https://www.fiercepharma.com/manufacturing/stada-earmarks-eu85m-build-out-middle-east-production-hub-saudi-arabia
13 Feb 2026
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/stada-and-bio-thera-receive-european-marketing-authorization-for-gotenfia-a-biosimilar-to-simponi-302687571.html
17 Nov 2025
// EMA
https://www.ema.europa.eu/en/documents/overview/kefdensis-epar-medicine-overview_en.pdf
17 Nov 2025
// EMA
https://www.ema.europa.eu/en/documents/overview/zvogra-epar-medicine-overview_en.pdf
17 Nov 2025
// EMA
https://www.ema.europa.eu/en/documents/overview/usgena-epar-medicine-overview_en.pdf
22 Sep 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/09/22/3153748/0/en/European-Medicines-Agency-Recommends-Marketing-Authorization-of-AVT03-Alvotech-s-Proposed-Biosimilar-to-Prolia-and-Xgeva.html
Drugs in Development
Details:
Golimumab, an unconjugated antibody targeting TNF-alpha, shows promise in treating chronic inflammatory autoimmune diseases.
Lead Product(s): Golimumab
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Antibody, Unconjugated
Recipient: Bio-Thera Solutions
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 13, 2026
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Recipient : Bio-Thera Solutions
Deal Size : Inapplicable
Deal Type : Inapplicable
Stada, Bio-Thera Get EU Approval for Gotenfia, Biosimilar to Simponi
Details : Golimumab, an unconjugated antibody targeting TNF-alpha, shows promise in treating chronic inflammatory autoimmune diseases.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
February 13, 2026
Details:
Kinpeygo (budesonide)is a modified-release capsule, glucocorticoid receptor agonist, which is indicated for the treatment of patients with primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Brand Name: Kinpeygo
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 26, 2024
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : 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
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.
Lead Product(s): Ustekinumab
Therapeutic Area: Immunology Brand Name: Uzpruvo
Study Phase: Approved FDFProduct Type: Antibody, Unconjugated
Sponsor: Alvotech
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 22, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : 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
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.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibody, Unconjugated
Recipient: Alvotech
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 11, 2024
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : 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
Details:
Under the agreement, Bio-Thera Solutions will maintain responsibility for development, manufacturing, and supply of BAT2506, a biosimilar candidate to Simponi® (golimumab).
Lead Product(s): Golimumab
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibody, Unconjugated
Recipient: Bio-Thera Solutions
Deal Size: $157.5 million Upfront Cash: $10.0 million
Deal Type: Licensing Agreement 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
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
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.
Lead Product(s): Ustekinumab
Therapeutic Area: Immunology Brand Name: Uzpruvo
Study Phase: Approved FDFProduct Type: Antibody, Unconjugated
Sponsor: Alvotech
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 10, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : 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
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.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Brand Name: Uzpruvo
Study Phase: Phase IIIProduct Type: Antibody, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 10, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : 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
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.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Brand Name: Ximluci
Study Phase: Approved FDFProduct Type: Antibody, Unconjugated
Sponsor: Xbrane Biopharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 16, 2023
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Xbrane Biopharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Stada and Xbrane Obtain British Approval for Ximluci® (ranibizumab) Biosimilar Referencing Lucent...
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
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.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Brand Name: Hukyndra
Study Phase: Approved FDFProduct Type: Antibody, Unconjugated
Recipient: Alvotech
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 07, 2022
Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Highest Development Status : 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
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.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Brand Name: Hukyndra
Study Phase: Approved FDFProduct Type: Antibody, Unconjugated
Recipient: Alvotech
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 22, 2022
Lead Product(s) : Adalimumab
Therapeutic Area : Immunology
Highest Development Status : 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
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