Biosimilar Pipeline

Biosimilar of Forteo, teriparatide is a recombinant human parathyroid hormone (also known as rhPTH) that acts as an anti-osteoporosis agent. It is indicated for the treatment of postmenopausal women with osteoporosis and to increase bone mass in men with primary or hypogonadal osteoporosis. as well as for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.

Biosimilar of Prolia, Denosumab is a human IgG2 monoclonal antibody. Prolia is indicated for the treatment of Postmenopausal osteoporosis, fractures, bone loss in patients undergoing hormone ablation for cancer along with inhibition of the progression of bone erosion associated with rheumatoid arthritis.

Denosumab biosimilar of Xgeva is a human monoclonal antibody of the immunoglobulin G2 (IgG2) which acts as an antineoplastic agent. Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases in patients with multiple myeloma and giant cell tumor of bone.

Romiplostim is the biosimilar of Nplate which is a Fc-peptide fusion protein. Nplate is indicated for the treatment of adults, and pediatrics- 1 year and older with long-term immune thrombocytopenic purpura (ITP), and for the treatment of aplastic anemia (AA) in patients who have had an inadequate response to conventional therapy in adults.

Adalimumab is the biosimilar of Humira, a human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Humira is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

Biosimilar of Erbitux, Cetuximab is a chimeric monoclonal IgG1 antibody that acts as an anti-neoplastic agent. Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer and for the treatment of patients with squamous cell cancer of the head and neck. It is also indicated for the treatment of K-Ras Wild-type, EGFR-expressing colorectal cancer, and for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil.

Bevacizumab biosimilar ofAvastin is a recombinant humanized monoclonal IgG1 antibody. Avastin is used for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer (with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease) and glioblastoma, with interferon alfa.

A biosimilar of Lucentis, Ranibizumab is a humanized monoclonal antibody fragment and a recombinant humanized IgG1 isotype designed to bind and inhibit vascular endothelial growth factor (VEGF-A). Lucentis is indicated for the treatment of patients with neovascular (Wet) age-related macular degeneration, macular edema following retinal vein occlusion (RVO) and diabetic macular edema.

Biosimilar to Victoza, Liraglutide is a potent anti-diabetic agent. It is the first and only human GLP-1 analog drug, engineered biotechnologically to be about 97 percent homologous to the Glucagon like peptide 1 (GLP-1) expressed in humans through the substitution of lysine at 34th position with arginine. It is indicated as an adjunct to diet and exercise for improving glycemic control in adults with Type IIDiabetes Mellitus and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non- fatal myocardial infarction, or non- fatal stroke) in such adults. It is indicated for the treatment of pediatric patients of 10 years or older with Type II Diabetes .

Pertuzumab biosimilar to Perjeta belongs to anti-neoplastic agent’s class. Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.

Tocilizumab biosimilar of Actemra is a humanized monoclonal antibody, acts as immunosupressant preparation. Actemra is indicated for the treatment of rheumatoid arthritis in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease modifying anti-rheumatic drugs via intravenous and subcutaneous route.

Biosimilar to Victoza, Liraglutide is a potent anti-diabetic agent. It is the first and only human GLP-1 analog drug, engineered biotechnologically to be about 97 percent homologous to the Glucagon like peptide 1 (GLP-1) expressed in humans through the substitution of lysine at 34th position with arginine. It is indicated as an adjunct to diet and exercise for improving glycemic control in adults with Type IIDiabetes Mellitus and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non- fatal myocardial infarction, or non- fatal stroke) in such adults. It is indicated for the treatment of pediatric patients of 10 years or older with Type II Diabetes .

Plecanatide generic of Trulance is a uroguanylin anlogue. Trulance is indicated for the treatment of chronic idiopathic constipation, treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

Atosiban is a tocolytic agent which is indicated fordelay of imminent pre-term birth in pregnant adult women.

A generic of Tymlos, Abaloparatide is a synthetic peptide analog of PTHrP (parathyroid hormone-related protein). Tymlos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The transdermal formulation of BA-058 is based on micro-structured transdermal system technology.