Products for license

We have launched several biosimilar products by leveraging our strong pipeline to help increase healthcare accessibility. 

Why are biosimilars in demand?

Biosimilars have no clinical differentiation from existing, approved biologics, with equivalent efficacy and safety. Product demand is increasing because of:

  • Patent expirations: The expiration of patents for many blockbuster biologics has paved the way for biosimilar manufacturers to develop and commercialize these products
  • Cost-effectiveness: Healthcare systems worldwide are facing increasing pressure to control costs. Biosimilars offer a more affordable alternative to biologics while maintaining comparable efficacy and safety. This cost-effectiveness makes biosimilars an attractive option for healthcare payers and providers
  • Technological advancements: Advancements in biotechnology have enabled the development of biosimilars that are highly similar to their originator products. This has addressed concerns about immunogenicity and other potential risks associated with biosimilars
  • Regulatory support: Regulatory agencies worldwide have played a significant role in supporting the development and approval of biosimilars. Establishing clear regulatory pathways and guidelines has facilitated the timely and efficient evaluation of biosimilar applications

 

Our biosimilars products

The development and manufacture of biosimilars is a complex and challenging process.

We have invested in our biosimilar capabilities with our advanced pipeline and EnzeneXTM continuous bioprocess manufacturing, allowing us to develop, manufacture and launch a range of biosimilar products.

Wave I product pipeline

Originator

Disease Indication

Treatments

Launch Year

Market/Territory

Teriparatide (Forteo®)

Osteoporosis

A recombinant human parathyroid hormone that acts as an anti-osteoporosis agent. Used to treat postmenopausal women and to increase bone mass in men with osteoporosis. Also used to treat men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.

FY21

India, Global

Denosumab (Prolia®)

Postmenopausal osteoporosis

A human IgG2 monoclonal antibody (mAb) used to treat postmenopausal osteoporosis, fractures and bone loss in patients undergoing hormone ablation for cancer, as well as inhibition of the progression of bone erosion associated with rheumatoid arthritis.

FY22, FY24-FY26

India, Global

Denosumab (Xgeva®)

Giant cell tumor of bone

A human IgG2 mAb that acts as an antineoplastic agent for the prevention of skeletal-related events in patients with bone metastases from multiple myeloma and giant cell tumor of bone.

FY22, FY24-FY26

India, Global

Romiplostim (Nplate®)

Immune thrombocytopenic purpura (ITP)

An Fc-peptide fusion protein for treating adults and pediatrics (1+) with long-term ITP, and for treating aplastic anemia (AA) in adults with inadequate response to conventional therapy.

FY22, FY24

India, Global

Adalimumab (Humira®)

Rheumatoid arthritis

A human IgG1 mAb for human tumor necrosis factor (TNF). Used to reduce signs and symptoms, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

FY23

India

Cetuximab (Erbitux®)

Squamous cell cancer of the head and neck

A chimeric igG1 mAb that acts as an anti-neoplastic agent for treating patients with epidermal growth factor receptor (EGPR)-expressing, RAS wild-type metastatic colorectal cancer and for the treatment of patients with squamous cell cancer of the head and neck.

FY24

India, Global

Bevacizumab (Avastin®)

Metastatic colorectal cancer

A recombinant humanized IgG1 mAb used to treat metastatic colorectal cancer, non-squamous non-small cell lung cancer and glioblastoma.

FY24

India, Global

Ranibizumab (Lucentis®)

Neovascular (Wet) age-related macular degeneration

A humanized mAb fragment and a recombinant humanized igG1 isotype designed to bind and inhibit vascular endothelial growth factor (VEGF-A). Used for treating neovascular (Wet) age-related macular degeneration, macular edema following retinal vein occlusion (RVO), and diabetic macular edema.

FY24

India

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Wave II product pipeline

Originator

Disease Indication

Treatments

Launch Year

Market/Territory

Nivolumab (Opdivo®)

Cancer of the lungs, kidneys, liver, bladder and stomach

A humanized mAb which acts as an immune checkpoint inhibitor. Targets and blocks PD-1 protein on the surface of T-cells.

FY26

India

Omalizumab (Xolair®)

Persistent asthma, nasal polyps and chronic spontaneous urticaria

A humanized mAb that binds IgE. When overproduced IgE leads to an allergic response, by removing free IgE in the blood, symptoms of an allergic response are reduced.

FY26

India

Benralizumab (Fasenra®)

Severe eosinophilic asthma

A humanized mAb that attaches to interleukin-5 receptors on the surface of eosinophils, interfering with binding and activating an immune response.

FY27

TBD

Golimumab (Simponi®)

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis

A humanized mAb that inhibits TNF-a reducing inflammation and other disease symptoms.

FY27

India

Vedolizumab (Entyvio®)

Ulcerative colitis and Crohn’s disease

A humanized mAb designed to bind alfa-4-beta-7 integrin, a protein found on the surface of certain white blood cells in the gut, reducing inflammation.

FY28

India

Secukinumab (Cosentyx®)

Psoriasis, ankylosing spondylitis and psoriatic arthritis

A humanized mAb which inhibits IL-17 in the blood. This reduces immune responses and symptoms.

FY28

India

Pembrolizumab (Keytruda®)

Melanoma, lung cancer, head and neck cancer, Hodgkin’s lymphoma, and stomach cancer

A humanized mAb which acts as an immune checkpoint inhibitor. Targets and blocks PD-1 and PD-L1 proteins on the surface of T-cells.

FY29

Global and India

Daratumumab (Darzalex®)

Multiple myeloma

A humanized mAb that binds to CD38 proteins on the surface of myeloma cells. These cells can then be killed by the immune system.

FY29

India

Natalizumab (Tysabri®)

Relapsing forms of multiple sclerosis and Crohn's disease

A humanized mAb that binds ɑ4-integrin present on white blood cells. This prevents autoreactive leukocytes from entering target organs and reduces inflammation.

FY29

India

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Partners we work with

Biomm

Centurion

Ipca

Lupin

Mankind pharma

Pharmasyntez

Shin Poong Pharm

Theramex

Start your biosimilars journey

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