A biologic medicine is derived from living organisms and is manufactured through highly involved and stringently controlled biotechnology processes. As biologic medicines, biosimilars are inherently different from generics due to their molecular size and structure, and the complexity and cost of their development. Biosimilars also have significantly higher research and development costs and risks and are more complex to manufacture than small-molecule generics.

Biosimilars have the potential to provide additional treatment options at lower cost, but development requires significant investment. Biosimilar development may take five to nine years and cost more than $100 million, not including regulatory fees. A generic, however, costs $1-2 million and takes approximately two years to develop.

Example of some of the biosimilars approved in India

Product name Active drug Indications
Glaritus Insulin glargine Diabetes mellitus
Grafeel Filgrastim Neutropenia
Epofer Epoetin alfa Anemia
Adfar Adalimumab RA, Crohn’s disease
Erbitux Cetuximab Colorectal carcinoma
Krabeva Bevacizumab Colorectal cancer
Herceptin Trastuzumab Breast cancer
Intacept Etanercept RA
Abcixirel Abciximab Autoimmune disease
Relibeta Interferon beta-1a Multiple sclerosis
Relipoietin Epoetin alfa Anemia, autologous blood transfusion, chronic kidney failure, HIV
Shankinase Streptokinase Arterial occlusions, deep vein thrombosis, pulmonary embolism
Razumab Ranibizumab Wet macular degeneration, macular edema, degenerative myopia
Terifrac Teriparatide (parathyroid hormone) Postmenopausal women with osteoporosis who are at high risk for fracture

RA = rheumatoid arthritis, HIV = human immunodeficiency virus

About AMJEVITA™ (adalimumab-atto)
AMJEVITA is a biosimilar to Humira®* (adalimumab), 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 including moderate-to-severe rheumatoid arthritis in adults, moderate-to-severe polyarticular juvenile idiopathic arthritis in patients 2 years of age and older, psoriatic arthritis in adults, ankylosing spondylitis in adults, moderate-to-severe chronic plaque psoriasis in adults, moderate-to-severe Crohn’s disease in adults and pediatric patients 6 years of age and older and moderate-to-severe ulcerative colitis in adults.2 AMJEVITA outside the U.S. is marketed as AMGEVITA® (adalimumab) and has been prescribed to more than 300,000 patients in over 60 countries.

*Humira® is a registered trademark of AbbVie, Inc.
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