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As they approach patent expiry, biologics used for certain diseases (principally within the fields of oncology, diabetes and autoimmune disorders) have emerged as frontrunners for biosimilar development. A number of these products have already been targeted and the list will continue to increase over time as more patents expire.

Clinical trials needed to support biosimilar development typically come in waves of activity based on patent expiry dates, as sponsors compete to be first to obtain regulatory approval and claim optimal market share. In the USA, biosimilar sponsors can even be granted 1 year of marketing exclusivity if their product is deemed to be ‘interchangeable’ by the FDA.

Originator biologics actively targeted for biosimilar development are listed alphabetically below with their approved indications. Clinical trials for biosimilar candidates are currently being conducted or anticipated in the highlighted indications. Click on the links to learn more about the role of biosimilars within these indications and consider becoming a biosimilar investigator today.


Abatacept   +

Adalimumab   +

Rheumatoid arthritis (EU & USA)
Psoriasis (EU & USA)
Juvenile idiopathic arthritis (EU & USA)
Psoriatic arthritis (EU & USA)
Ankylosing spondylitis (EU & USA)
Crohn’s disease (EU & USA)
Ulcerative colitis (EU & USA)

Aflibercept/ziv-aflibercept   +

Wet age-related macular degeneration (wAMD) (EU & USA)
Macular edema following retinal vein occlusion (RVO) (EU & USA)
Diabetic macular edema (DME) (EU & USA)
Metastatic colorectal cancer (EU & USA)
Bevacizumab   +

Non-small cell lung cancer (non-squamous) (EU & USA)
Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (EU & USA)
Metastatic breast cancer (EU)
Metastatic colorectal cancer (EU & USA)
Metastatic renal cell carcinoma (EU & USA)
Cervical carcinoma (USA)
Glioblastoma (USA)
Darbepoetin alfa   +

Symptomatic anemia associated with chronic renal failure (EU & USA)
Symptomatic anemia in adults with non-myeloid malignancies receiving chemotherapy (EU & USA)
Denosumab   +

Bone metastases from solid tumors (EU & USA)
Eculizumab   +

Paroxysmal nocturnal hemoglobinuria (PNH) (EU & USA)
Atypical hemolytic uremic syndrome (aHUS) (EU & USA)
Etanercept   +

Rheumatoid arthritis (EU & USA)
Psoriasis (EU & USA)
Juvenile idiopathic arthritis (EU & USA)
Psoriatic arthritis (EU & USA)
Ankylosing spondylitis (EU & USA)
Golimumab   +

Rheumatoid arthritis (EU & USA)
Psoriatic arthritis (EU & USA)
Ankylosing spondylitis (EU & USA)
Ulcerative colitis (EU & USA)

Infliximab*   +

Rheumatoid arthritis (EU & USA)
Psoriasis (EU & USA)
Crohn’s disease (EU & USA)
Ulcerative colitis  (EU & USA)
Ankylosing spondylitis (EU & USA)
Psoriatic arthritis (EU & USA)

Insulin aspart   +

Type 1 and 2 diabetes mellitus (adults and children) (EU & USA)

Insulin determir   +

Type 1 and 2 diabetes mellitus (adults and children) (EU & USA)
Insulin glargine*   +

Type 1 diabetes mellitus (adults and children) (EU & USA)
Type 2 diabetes mellitus (adults) (EU & USA)
Type 2 diabetes mellitus (children) (EU)
Insulin lispro   +

Type 1 and 2 diabetes mellitus (adults and children) (EU & USA)

Ipilimumab   +

Metastatic or unresectable malignant melanoma (EU & USA)
Natalizumab   +

Relapsing-remitting multiple sclerosis (EU & USA)
Crohn’s disease (USA)
Omalizumab   +

Severe persistent allergic asthma (EU & USA)
Chronic idiopathic/spontaneous urticaria (EU & USA)
Pegfilgrastim   +

Neutropenia in cancer patients receiving chemotherapy (EU & USA)
Ranibizumab   +

Wet age-related macular degeneration (wAMD) (EU & USA)
Macular edema following retinal vein occlusion (RVO) (EU & USA)
Diabetic macular edema (DME) (EU & USA)
Choroidal neovascularization secondary to pathologic myopia (EU)
Rituximab   +

Rheumatoid arthritis (EU & USA)
Non-Hodgkin’s lymphoma (EU & USA)
Chronic lymphocytic leukemia (EU & USA)
Granulomatosis with polyangiitis (USA)

Tocilizumab   +

Rheumatoid arthritis (EU & USA)
Systemic juvenile idiopathic arthritis (EU & USA)
Polyarticular juvenile idiopathic arthritis (EU & USA)

Trastuzumab   +

HER2-overexpressing breast cancer (EU & USA)
HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma (EU & USA)
Ustekinumab   +

Plaque psoriasis (EU & USA)
Psoriatic arthritis (EU & USA)

*Biosimilars of these products have already been licensed in certain markets.

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