Adalimumab (Humira) — Competitive Intelligence Brief

Adalimumab (Humira) (Adalimumab (Humira)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: TNF-α inhibitor (monoclonal antibody). Area: Immunology.

marketed TNF-α inhibitor (monoclonal antibody) TNF-α (Tumor Necrosis Factor-alpha) Immunology Small molecule

Target snapshot

Adalimumab (Humira) (Adalimumab (Humira)) — Tufts Medical Center. Adalimumab is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), a key inflammatory cytokine.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Adalimumab (Humira) TARGET	Adalimumab (Humira)	Tufts Medical Center	marketed	TNF-α inhibitor (monoclonal antibody)	TNF-α (Tumor Necrosis Factor-alpha)
Biosimilar Infliximab	Biosimilar Infliximab	Hikma Pharmaceuticals LLC	marketed	TNF-α inhibitor (monoclonal antibody)	TNF-α (tumor necrosis factor-alpha)
infliximab therapeutic drug monitoring	infliximab therapeutic drug monitoring	Imelda GI Clinical Research Center	marketed	TNF-α inhibitor (monoclonal antibody)	TNF-α (tumor necrosis factor-alpha)
Infliximab and immunosuppressives	Infliximab and immunosuppressives	Children's Hospital of Fudan University	marketed	TNF-α inhibitor (monoclonal antibody) + immunosuppressive agents	TNF-α receptor (via infliximab); multiple targets depending on co-administered immunosuppressive
SB5	SB5	Samsung Bioepis Co., Ltd.	marketed	TNF-α inhibitor (monoclonal antibody); biosimilar	TNF-α (tumor necrosis factor-alpha)
Adalimumab and its biosimilars	Adalimumab and its biosimilars	Hanyang University Seoul Hospital	marketed	TNF-α inhibitor (monoclonal antibody)	TNF-α (tumor necrosis factor-alpha)
Adalimumab (ADA)	Adalimumab (ADA)	JHSPH Center for Clinical Trials	marketed	TNF-α inhibitor (monoclonal antibody)	TNF-α (tumor necrosis factor-alpha)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (TNF-α inhibitor (monoclonal antibody) class)

1. Merck Sharp & Dohme LLC · 3 drugs in this class
2. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · 2 drugs in this class
3. Hanyang University Seoul Hospital · 2 drugs in this class
4. Biocad · 1 drug in this class
5. Children's Memorial Health Institute, Poland · 1 drug in this class
6. Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · 1 drug in this class
7. Centocor, Inc. · 1 drug in this class
8. Hikma Pharmaceuticals LLC · 1 drug in this class
9. Hospital de Manises · 1 drug in this class
10. Celltrion · 1 drug in this class