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Details:
RT-111 (ustekinumab-biosimilar) is an oral anti-IL 12/23 antibody. It is being evaluated in phase 1 clinical trials for the treatment of of moderate to severe plaque psoriasis, Crohn’s disease, ulcerative colitis & active psoriatic arthritis.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: RT-111
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 05, 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: Gastroenterology Product Name: Uzpruvo
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alvotech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2024
Details:
DMB-3115 (ustekinumab-biosimilar) is an IL-12/23 inhibitor which is being evaluated in phase 3 clinical trials for the treatment of patients with moderate-to-severe chronic plaque psoriasis.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: DMB-3115
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Intas Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2024
Details:
The agreement aims for the commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of reference medicine Stelara (ustekinumab) in the United States (US).
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: SB17
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Johnson & Johnson
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement November 30, 2023
Details:
Jamteki (ustekinumab) is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: Jamteki
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2023
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 Product Name: Uzpruvo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2023
Details:
Wezlana (ustekinumab-auub) is a biosimilar of Stelara (ustekinumab) is approved for multiple inflammatory diseases like moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease & ulcerative colitis.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: Wezlana
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 31, 2023
Details:
AVT04 (ustekinumab) is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: AVT04
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2023
Details:
Through the spinoff, Novartis will complete its transformation to become a leading, focused medicines company and Sandoz will work on its generic and biosimilars pipeline, including SB17 a proposed biosimilar to Stelara (ustekinumab).
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: SB17
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Demerger October 04, 2023
Details:
Through the divestment, Novartis will complete its transformation to become a leading, focused medicines company and Sandoz will work on its generic and biosimilars pipeline, including SB17 a proposed biosimilar to Stelara (ustekinumab).
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: SB17
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Demerger October 03, 2023
Details:
AVT04 (ustekinumab) is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: AVT04
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2023
Details:
Through the divestment, Novartis will complete its transformation to become a leading, focused medicines company and Sandoz will work on its generic and biosimilars pipeline, including SB17 a proposed biosimilar to Stelara (ustekinumab).
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: SB17
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Demerger September 25, 2023
Details:
RT-111 (ustekinumab) is an orally administered RaniPill®GO capsule containing an ustekinumab biosimilar that act as binds with specificity to the p40 protein subunit used by both the interleukin-12 and interleukin-23 for the treatment of psorasis.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: RT-111
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2023
Details:
Under the agreement, Sandoz will support Samsung Bioepis pipeline expansion by commercialising SB17, a proposed biosimilar to Stelara (ustekinumab) strengthening its immunology portfolio in the US, Canada, European Economic Area, Switzerland and UK.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: SB17
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Samsung Bioepis
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 11, 2023
Details:
FYB202 (ustekinumab biosimilar) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: FYB202
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Formycon
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 07, 2023
Details:
The net proceeds will be used for the continued development of its biosimilars pipeline, including AVT04, a monoclonal antibody, a biosimilar candidate to Stelara (ustekinumab).
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: AVT04
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: ATP Holdings
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement July 31, 2023
Details:
DMB-3115 (ustekinumab) is a proposed biosimilar to Stelara being used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: DMB-3115
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 17, 2023
Details:
Under the agreement, Biomm will have exclusive rights to distribute and market BAT2206 (ustekinumab), a proposed biosimilar to Janssen’s Stelara, in Brazil for the treatment of active psoriatic arthritis.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: BAT2206
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Biomm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 16, 2023
Details:
The agreement grants a license entry date for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab), in the United States. Ustekinumab is a monoclonal antibody and binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: AVT04
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 12, 2023
Details:
Stelara (ustekinumab) is a monoclonal antibody. Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses. It is approved for treating ulcerative colitis.
Lead Product(s): Ustekinumab
Therapeutic Area: Gastroenterology Product Name: Stelara
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2023
Details:
AVT04 (ustekinumab) is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: AVT04
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2023
Details:
DMB-3115 (ustekinumab) and Stelara demonstrated therapeutic equivalence when looking at percent change from baseline in PASI (Psoriasis Area and Severity Index) at Week 8 and Week 12.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: DMB-3115
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 17, 2023
Details:
Rani is granted an exclusive license to use CT-P43 in the development and commercialization of RT-111, an orally administered ustekinumab biosimilar and Celltrion is granted a right of first negotiation to acquire worldwide rights to RT-111 following a Phase 1 clinical trial.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: RT-111
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Celltrion
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 09, 2023
Details:
AVT04 (Ustekinumab) is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: AVT04
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2023
Details:
RT-111, a RaniPill GO capsule containing a biosimilar of STELARA® (ustekinumab) is an interleukin-12 and interleukin-23 antagonist for the potential treatment of psoriatic arthritis, ulcerative colitis, Crohn’s disease and psoriasis.
Lead Product(s): Ustekinumab
Therapeutic Area: Endocrinology Product Name: RT-111
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Details:
Ustekinumab, a biosimilar of Stelara, is a monoclonal antibody used to treat several autoimmune conditions and Denosumab, a biosimilar referencing Prolia®, is a monoclonal antibody for the treatment of osteoporosis.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Biocon
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 17, 2022
Details:
55.2 percent of induction responder patients treated with STELARA (ustekinumab) at the start of maintenance were in symptomatic remission approximately four years later (at week 200), 96.4 percent without corticosteroids.
Lead Product(s): Ustekinumab
Therapeutic Area: Immunology Product Name: Stelara
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 10, 2022
Details:
STELARA is a fully human monoclonal antibody that selectively inhibits both interleukin (IL)-12 and IL-23, two cytokines thought to play an important role in tempering the overactive inflammatory response in several autoimmune diseases.
Lead Product(s): Ustekinumab
Therapeutic Area: Immunology Product Name: Stelara
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2022
Details:
AVT04 (ustekinumab) is a human IgG1k monoclonal antibody that binds with specificity to the p40 protein subunit present in both the IL-12 and IL-23 cytokines.
Lead Product(s): Ustekinumab
Therapeutic Area: Immunology Product Name: AVT04
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2022
Details:
Results from pharmacokinetic similarity study demonstrate bioequivalence of AVT04 (ustekinumab), a human IgG1k monoclonal antibody that binds with specificity to p40 protein subunit used by both interleukin-12 and interleukin-23 cytokines to reference product Stelara.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: AVT04
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
The structure of the transaction will involve Formycon acquiring all the rights in FYB202, a biosimilar candidate for Stelara® (ustekinumab), as well as a 50% share in FYB201, a biosimilar candidate for Lucentis®2 (ranibizumab).
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: FYB202
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Athos Therapeutics
Deal Size: $720.7 million Upfront Cash: Undisclosed
Deal Type: Acquisition May 10, 2022
Details:
The primary analysis evaluated the percentage improvement from baseline to week 12 of psoriasis area severity index (PASI), which showed a mean difference of percentage improvement between ABP 654 and STELARA of 0.14, which was within the prespecified margins.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: ABP 654
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 18, 2022
Details:
The structure of the transaction will involve Formycon acquiring all the rights in FYB202, a biosimilar candidate for Stelara® (ustekinumab), as well as a 50% share in FYB201, a biosimilar candidate for Lucentis®2 (ranibizumab).
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: FYB202
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Formycon
Deal Size: $720.7 million Upfront Cash: Undisclosed
Deal Type: Acquisition March 29, 2022
Details:
This partnership will leverage Pharmapark’s strong local presence, sales and marketing capabilities in Russia and other CIS countries. Bio-Thera will be responsible for full development, and commercial supply of BAT2206 out of its manufacturing facilities in Guangzhou, China.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: BAT2206
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Pharmapark
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 16, 2021
Details:
STELARA is the first and only biologic targeting both cytokines interleukin (IL)-12 and IL-23, both of which play an important role in inflammation associated with immune-mediated diseases like PsA.
Lead Product(s): Ustekinumab
Therapeutic Area: Immunology Product Name: Stelara
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2021
Details:
STELARA® (ustekinumab) is a fully human monoclonal antibody and is first biologic treatment to selectively inhibit IL-12 and IL-23 pathways. STELARA is approved in United States for treatment of moderate to severe plaque psoriasis.
Lead Product(s): Ustekinumab
Therapeutic Area: Gastroenterology Product Name: Stelara
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206. Hikma will have exclusive rights to commercialize the product in the US.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: BAT2206
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Hikma Pharmaceuticals
Deal Size: $150.0 million Upfront Cash: $20.0 million
Deal Type: Licensing Agreement August 27, 2021
Details:
The clinical study is a multicenter, randomized, double-blind, and parallel controlled study to compare the efficacy and safety of BAT2206 to Stelara® in moderately to severely psoriatic (PsO) patients that is expected to enroll approximately 472 volunteers.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: BAT2206
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 12, 2021
Details:
Under the terms of the agreement, Intas was granted the exclusive license rights to market DMB-3115 worldwide, excluding Japan, Korea and certain countries in Asia.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: DMB-3115
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Intas Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 21, 2021
Details:
AVT04 is the second proposed biosimilar product from Alvotech entering clinical studies, the first being AVT02, a proposed biosimilar to Humira®.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: AVT04
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2021
Details:
Safety results were consistent with prior experience for both treatments. Discontinuation rates were numerically lower for STELARA-treated patients (15.2 percent) versus adalimumab-treated patients (23.6 percent) who discontinued before week 52.
Lead Product(s): Ustekinumab
Therapeutic Area: Gastroenterology Product Name: Stelara
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2021
Details:
A single subcutaneous injection of DMB3115 in healthy volunteers was well tolerated. The reported adverse events corresponded with the known safety profile of ustekinumab.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: DMB-3115
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Dong-A Socio Holdings
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2021
Details:
The aim of the randomized, double-blind, multi-center Phase III study is to demonstrate the comparability of FYB202 and the reference product Stelara(R) in terms of efficacy, safety and immunogenicity in patients with moderate to severe psoriasis vulgaris.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: FYB202
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Bioeq IP AG
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
All pre-specified criteria showed the clinical pharmacokinetic (PK) similarity of NeuLara, compared to US- and EUsourced Stelara®. NeuLara is being developed as a biosimilar of ustekinumab, an antibody targeting interleukin-12 and -23, approved under the brand name Stelara®.
Lead Product(s): Ustekinumab
Therapeutic Area: Immunology Product Name: NeuLara
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2020
Details:
More than half of the patients with moderately to severely active CD who were randomized to subcutaneous STELARA every 8 weeks and continued to receive this dosage in the LTE study maintained clinical response3 and remission through five years of treatment.
Lead Product(s): Ustekinumab
Therapeutic Area: Gastroenterology Product Name: Stelara
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2020
Details:
Company has begun dosing patients in a Phase I clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed biosimilar of Stelara® (ustekinumab), to US-sourced and EU-sourced reference product in normal healthy volunteers.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: BAT2206
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
STELARA is the first and only biologic to target interleukin (IL)-12 and IL-23 approved for pediatric psoriasis use, providing a new proven treatment for children (6-11 years of age) who have had few available options.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: Stelara
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 30, 2020
Details:
The decision is based on data from a pre-planned interim efficacy analysis. Interim safety findings were consistent with the known safety profile of STELARA, and no new safety signals were identified.
Lead Product(s): Ustekinumab
Therapeutic Area: Immunology Product Name: Stelara
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 26, 2020
Details:
Scottish Medicines Consortium has accepted Janssen Pharmaceutical’s Stelara for use on the National Health Service Scotland to treat moderately to severely active ulcerative colitis (UC) in adults.
Lead Product(s): Ustekinumab
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2020
Details:
First study to explore a treat-to-target strategy in crohn’s disease using endoscopy to guide dose adjustment. First study to evaluate intestinal ultrasound monitoring in an interventional setting.
Lead Product(s): Ustekinumab
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2020