Another biosimilar for NeuClone with the Australian-based company announcing the addition of a denosumab candidate to its existing portfolio.
Denosumab, a monoclonal antibody, is better known as Amgen's popular PBS-listed bone therapy PROLIA/XGEVA.
According to official PBS statistics, the franchise attracted government spending of almost $150 million in 2016-17, up strongly compared to the previous year.
NeuClone has previously announced four biosimilar candidates in its portfolio: trastuzumab (HERCEPTIN); ustekinumab (STELARA); adalimumab (HUMIRA); and, palivizumab (SYNAGIS).
The company said it has partnered with Serum Institute of India for the manufacture of ten biosimilars, including denosumab, and that under the collaboration it is responsible for preclinical development and biosimilar product characterisation. The Serum Institute of India is responsible for process development and supply of commercial and clinical product.
“We are dedicated to broaden patient access to biological medicines globally by making affordable products of the highest quality. At all stages of development, we are focused on global approval from the most stringent regulatory bodies including the U.S. and European agencies,” said NeuClone CEO Dr Noelle Sunstrom.
According to executive chairman, Dr Russell Howard, “As a third wave biosimilar, with patent protection likely for several more years, the progression of our denosumab biosimilar and its potential as an early market entrant is incredibly exciting and demonstrates our long-term focus on developing a pipeline of multiple mAb biosimilar products.”
The company said it is seeking commercialisation partners with expertise in Phase 3 clinical trials, experience in regulatory filing and a channel to market.