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Details:
HUMIRA® is a fully human anti-TNF-α monoclonal antibody, got additional approval for a highdose regimen in adult patients with ulcerative colitis and for a new regimen in pediatric patients.
Lead Product(s): Adalimumab
Therapeutic Area: Gastroenterology Product Name: Humira
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2021
Details:
HUMIRA (adalimumab) is the first and only subcutaneous biologic treatment option for pediatric patients from 5 years of age with moderately to severely active ulcerative colitis.
Lead Product(s): Adalimumab
Therapeutic Area: Gastroenterology Product Name: Humira
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 24, 2021
Details:
Approval for adalimumab based on results from the pivotal Phase 3 ENVISION I study showing the higher dosage of HUMIRA induced clinical remission in 60 percent of patients at Week 8 and 45 percent of patients, who responded at Week 8, were in remission at Week 52.
Lead Product(s): Adalimumab
Therapeutic Area: Gastroenterology Product Name: Humira
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2021
Details:
Simlandi (adalimumab) is the first interchangeable, high-concentration, citrate-free biosimilar to Humira approved for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis and Crohn’s disease.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: Simlandi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2024
Details:
Hyrimoz (adalimumab-adaz) binds with specificity to TNF-alpha and inhibits its interaction with the p55 and p75 cell surface TNF receptors, which is approved for rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: Hyrimoz
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 21, 2023
Details:
RT-105 (adalimumab) is a monoclonal antibody which inhibits tumor necrosis factor. It binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: RT-105
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 19, 2023
Details:
AVT02 (adalimumab-aqvh) is a monoclonal antibody which inhibits tumor necrosis factor. It binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: AVT02
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 20, 2023
Details:
AVT02 (adalimumab-aqvh) is a monoclonal antibody which inhibits tumor necrosis factor. It binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: AVT02
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Bioventure Healthcare
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2023
Details:
The Company intends to use the net proceeds for research and development of its pipeline of novel program to treat several inflammatory disorders using anti-TNF (tumor necrosis factor), including adalimumab for the treatment of early-stage Dupuytren’s disease.
Lead Product(s): Adalimumab
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alliance Global Partners
Deal Size: $3.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 14, 2023
Details:
The Company intends to use the net proceeds for research and development of its pipeline of novel program to treat several inflammatory disorders using anti-TNF (tumor necrosis factor), including adalimumab for the treatment of early-stage Dupuytren’s disease.
Lead Product(s): Adalimumab
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alliance Global Partners
Deal Size: $3.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 10, 2023
Details:
Adalimumab, anti-TNF therapeutic, approved and used under the brand name Humira for several autoimmune conditions, is being developed for the treatment of early-stage Dupuytren’s Contracture.
Lead Product(s): Adalimumab
Therapeutic Area: Musculoskeletal Product Name: Humira
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2023
Details:
Teva and Alvotech are working on pending approval in the U.S. for AVT02 (adalimumab), a biosimilar candidate for Humira and it also includes four other biosimilars, one of which is AVT04, a proposed biosimilar for Stelara (ustekinumab), with pending FDA approval.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: AVT02
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries
Deal Size: $40.0 million Upfront Cash: Undisclosed
Deal Type: Partnership July 24, 2023
Details:
MoonLake intends to use the net proceeds to fund the ongoing advancement of M1095 (sonelokimab), a trivalent monomeric nanobody that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F for the treatment of inflammatory diseases.
Lead Product(s): Sonelokimab,Adalimumab
Therapeutic Area: Dermatology Product Name: M1095
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: SVB Securities
Deal Size: $400.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 28, 2023
Details:
M1095 (sonelokimab) is a humanized nanobody consisting of three VHH domains covalently linked by flexible glycine-serine spacers. It selectively binds with IL-17A and IL-17F and inhibit IL-17A/A, IL-17A/F, and IL-17F/F dimer, which investigated for hidradenitis suppurativa.
Lead Product(s): Sonelokimab,Adalimumab
Therapeutic Area: Dermatology Product Name: M1095
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2023
Details:
Cyltezo® Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to Humira® (adalimumab). Initially approved as a pre-filled syringe, Cyltezo is indicated to treat multiple chronic inflammatory diseases.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: Cyltezo
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2023
Details:
Under the agreement, Celltrion will exclusively supply to Rani the adalimumab biosimilar drug substance (CT-P17) required for the development of RT-105, an oral capsule containing a TNF-α inhibitor antibody being developed for the treatment of psoriatic arthritis.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: RT-105
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Rani Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 05, 2023
Details:
Cyltezo® Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to Humira® (adalimumab). Initially approved as a pre-filled syringe, Cyltezo is indicated to treat multiple chronic inflammatory diseases.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: Cyltezo
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 22, 2023
Details:
The collaboration aims to develop an autoinjector for clinical and potential subsequent commercial supply of MoonLake’s Nanobody® M1095 (sonelokimab) by using SHL Medical's market-proven Molly® modular platform technology.
Lead Product(s): Sonelokimab,Adalimumab
Therapeutic Area: Immunology Product Name: M1095
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: MoonLake Immunotherapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration May 03, 2023
Details:
AVT02 (adalimumab-aqvh) is a monoclonal antibody which inhibits tumor necrosis factor. It binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: AVT02
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 13, 2023
Details:
The Company intends to use the net proceeds from the offering for research and development of Humira (adalimumab), a tumor necrosis factor (TNF) blocker, for the treatment of Dupuytren Contracture.
Lead Product(s): Adalimumab
Therapeutic Area: Musculoskeletal Product Name: Humira
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alliance Global Partners
Deal Size: $3.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 10, 2023
Details:
The Company intends to use the net proceeds from the offering for research and development of Humira (adalimumab), a tumor necrosis factor (TNF) blocker, for the treatment of Dupuytren Contracture.
Lead Product(s): Adalimumab
Therapeutic Area: Musculoskeletal Product Name: Humira
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alliance Global Partners
Deal Size: $3.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 05, 2023
Details:
Hyrimoz (adalimumab) binds with specificity to tumor necrosis factor-alpha (TNF-alpha) and inhibits its interaction with the p55 and p75 cell surface TNF receptors. Currently being developed for early stage dupuytren’s disease.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: Hyrimoz
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 03, 2023
Details:
Adalimumab binds with specificity to tumor necrosis factor-alpha (TNF-alpha) and inhibits its interaction with the p55 and p75 cell surface TNF receptors. Currently being developed for early stage dupuytren’s disease.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2023
Details:
Adalimumab-bwwd is being launched for treating autoimmune disease like rheumatoid arthritis and ankylosis spondylitis. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology 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 23, 2023
Details:
PGN-OB1 (adalimumab) is a formulation of anti-TNF-alpha (anti-tumor necrosis factor alpha) monoclonal antibody delivered with the OBDS for the treatment of autoimmune conditions.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: PGN-OB1
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 16, 2023
Details:
AMJEVITA (adalimumab-atto) is an anti-TNF-α monoclonal antibody. The active ingredient of AMJEVITA is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as Humira. AMJEVITA is approved to treat seven inflammatory diseases.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: Amjevita
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 31, 2023
Details:
Hyrimoz (adalimumab) binds with specificity to tumor necrosis factor-alpha (TNF-alpha) and inhibits its interaction with the p55 and p75 cell surface TNF receptors. Currently being developed for early stage dupuytren’s disease.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: Hyrimoz
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 30, 2023
Details:
Adalimumab binds with specificity to tumor necrosis factor-alpha (TNF-alpha) and inhibits its interaction with the p55 and p75 cell surface TNF receptors. Currently being developed for early stage dupuytren’s disease.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2023
Details:
Simlandi (adalimumab) is a monoclonal antibody which inhibits tumor necrosis factor. It binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Product Name: Simlandi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2023
Details:
HADLIMA (Adalimumab-bwwd) is a biosimilar product of HUMIRA®, formulated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritisetc. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: Hadlima
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2023
Details:
Adalimumab is a monoclonal anti-tumor necrosis factor alpha antibody used in the treatment of a wide variety of inflammatory conditions such as rheumatoid arthritis, crohn's disease, and ankylosing spondylitis.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alliance Global Partners
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 23, 2022
Details:
AVT02 is a monoclonal antibody and has been approved as a biosimilar to Humira® (adalimumab) in the 27 EU member countries. FDA has completed review of Alvotech’s application of AVT02 as an interchangeable to high-concentration of Humira®.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Product Name: AVT02
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2022
Details:
Junmaikang (adalimumab) is a biosimilar of Humira, Junmaikang was approved in China for Rheumatoid arthritis, ankylosing spondylitis, Psoriasis, Crohn's disease, uveitis, polyarticular juvenile idiopathic arthritis and Crohn's disease in children.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: Junmaikang
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Mabwell Bioscience
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 20, 2022
Details:
Research at Oxford University has indicated an anti-TNF mechanism of Adalimumab can slow or prevent the proliferation of myoblast cells that lead to the formation and growth of the fibrous nodules/cords in the palm and possible finger contracture.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alliance Global Partners
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 20, 2022
Details:
Idacio® (adalimumab), is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira®. Adalimumab is a monoclonal antibody that binds TNFα and blocks its general cytokine effects.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Product Name: Idacio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2022
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 Product Name: Hukyndra
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: STADA Arzneimittel
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Details:
Adalimumab is an anti-TNF being developed for the treatment of early-stage dupuytren’s contracture. The MHRA reviewed the primary and secondary endpoints in the repurposing anti-TNF for treating dupuytren's disease (RIDD) trial.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2022
Details:
Adalimumab injection (UBP1211) for the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in children and Crohn’s disease in children has been approved by the National Medical Products Administration.
Lead Product(s): Adalimumab
Therapeutic Area: Gastroenterology Product Name: UBP1211
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2022
Details:
Based on results of Repurposing Anti-TNF Humira (adalimumab) for Treating Dupuytren's Disease (RIDD) trial, the study’s researchers analysed data on costs and quality of life.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Product Name: Humira
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2022
Details:
AVT02 / Ciptunec™ / Ardalicip™ (adalimumab), is a monoclonal antibody and approved biosimilar to Humira® (adalimumab), which inhibits tumor necrosis factor for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Product Name: AVT02
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
AMGEVITA is a biosimilar to adalimumab, a fully human immunoglobulin G1 monoclonal antibody that binds and neutralizes human tumor necrosis factor alpha (TNFα), a cytokine which mediates the inflammatory response.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: Amgevita
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 07, 2022
Details:
PGN-001 having Adalimumab drug substance was delivered in either single administration or daily repeat administration for three days by a surgically implanted intracecal (IC) catheter as a surrogate for direct delivery to the colon by the DDS.
Lead Product(s): Adalimumab
Therapeutic Area: Gastroenterology Product Name: PGN-001
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:
Eight animals showed detectable drug levels of a variant of Adalimumab (PGN-OB1) with an oral bioavailability average of 25% (range from 7-55%), excluding one animal with a late deployment at 72 hours post-dose.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: PGN-OB1
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 19, 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 Product Name: Hukyndra
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: STADA Arzneimittel
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2022
Details:
Long-term real-world data on the effectiveness and safety of SB5 (adalimumab) biosimilars in psoriasis is limited, and study results from BADBIR demonstrate that SB5 is just as safe and effective as its reference adalimumab.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Product Name: SB5
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 07, 2022
Details:
AVT02 is a monoclonal antibody that is being evaluated for biosimilarity and interchangeability to Humira® (adalimumab), which inhibits tumor necrosis factor (TNF).
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Product Name: AVT02
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 05, 2022
Details:
Approximately 50% of patients with Dupuytren’s disease treated with Adalimumab also have frozen shoulder and Professor Nanchahal has previously shown that that TNF, a pro-inflammatory protein, is a key driver of the fibrosis in early-stage Dupuytren’s disease.
Lead Product(s): Adalimumab
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: NIHR
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 2022
Details:
Approval of citrate-free, high-concentration HADLIMA™ (adalimumab-bwwd), TNF blocker indicator was based on clinical data from study that compare PK, safety, tolerability, and immunogenicity of two formulations of HADLIMA (100 mg/mL vs 50 mg/mL) in healthy volunteers.
Lead Product(s): Adalimumab,Methotrexate
Therapeutic Area: Immunology Product Name: Hadlima
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Organon
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2022
Details:
Biosimilar of adalimumab (UBP 1211) is recombinant humanised anti -tumour necrosis factor alpha (TNF-alpha) mAB, for treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in children and Crohn’s disease in children.
Lead Product(s): Adalimumab
Therapeutic Area: Gastroenterology Product Name: UBP1211
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 17, 2022
Details:
Humira approved as 50 mg/mL adalimumab product comprising citrate as formulation ingredient. An product was subsequently launched by AbbVie with high adalimumab concentration in absence of citrate, providing greater patient convenience due to the lower injection volumes.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology 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 August 09, 2022