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Serum Institute’s partner NeuClone develops mAb for breast cancer indication

NeuClone Pharmaceuticals Ltd., an Australian clinical-stage biopharmaceutical company, has disclosed the sixth biosimilar being developed in its pipeline of monoclonal antibody (mAb) products. The product is a biosimilar candidate of Perjeta (pertuzumab) currently in preclinical development.

Perjeta (pertuzumab) is FDA and EMA approved as a treatment for patients with HER2-positive early or metastatic breast cancer and is authorised for use only in combination with trastuzumab. In addition to the pertuzumab biosimilar, NeuClone is also developing a biosimilar of Herceptin (trastuzumab) currently in clinical development.

"Biosimilars are fast becoming a very important part of our pipeline," says Adar C. Poonawalla, CEO of Serum Institute of India. "NeuClone's biosimilar technology coupled with our low-cost, large-scale business model, will enable us to supply these critical antibody therapies to those previously unable to receive treatment."

Pertuzumab is an IgG1 humanized mAb that targets human epidermal growth factor receptor 2 (HER2). Approximately 20% of women diagnosed with breast cancer test positively for HER2. According to La Merie, Perjeta recorded global sales of $2.3 billion in 2017.

NeuClone's Perjeta (pertuzumab) biosimilar is partnered with Serum Institute of India (Serum). Under the partnership, NeuClone and Serum are developing ten biosimilars for global markets.

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