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www.fdanews.com/articles/172547-hetero-launches-rituximab-biosimilar-maball-in-india

Hetero Launches Rituximab Biosimilar Maball in India

August 10, 2015

Indian drugmaker Hetero has launched a biosimilar version of Roche’s Rituxan on the subcontinent, with plans to introduce it in key markets outside India through strategic partners.

The rituximab biosimilar, marketed as Maball, is indicated for use alone or with other drugs to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis.

The launch is Hetero’s second in the biosimilars market. In June 2014, Hetero collaborated with Cipla on the India launch of Actorise, a biosimilar version of Amgen’s anemia therapy Aranesp (darbepoetin alfa). The company is also developing biosimilar versions of Roche’s Avastin (bevacizumab), AbbVie’s Humira (adalimumab) and Roche’s Herceptin (trastuzumab).

The push in biosimilars builds on Hetero’s position as a major producer of generic drugs with annual revenues of $1.2 billion. In April, the FDA approved the company’s ANDA for a generic version of Otsuka’s Tourette syndrome therapy Abilify (arapiprazole). And last September, Gilead granted a licensing agreement for Hetero and six other firms to manufacture and distribute generic Sovaldi (sofosbuvir) in developing countries. — Jonathon Shacat