Biocon & Mylan launch Fulphila in Australia

Biocon Limited and Mylan NV together have launched Fulphila, a biosimilar of Neulasta (pegfilgrastim) in Australia. Fulphila is now available on the pharmaceutical benefits scheme (PBS). More affordable treatment options are available such as biosimilars for healthcare providers and their patients enable savings for healthcare systems around the world, including PBS in Australia.

Fulphila is the third biosimilar to be commercialised in Australia and its continued penetration of the biosimilars will enable higher cost savings for Australian healthcare system. It was the first biosimilar pegfilgrastim to be approved in US, which was successfully launched in July 2018, thus expanding access for patients in need of an affordable alternative. Fulphila has received regulatory approval in more than 30 countries around the world.

Fulphila is approved by Therapeutic Goods Administration for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and also, to reduce the incidence of infections, as manifested by febrile neutropenia.

Neutropenia is a condition in which the number of neutrophils (a type of white blood cell) in the bloodstream is decreased, affecting the body's ability to fight off infections.

The approval of Fulphila was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that the product is highly similar to Neulasta and no clinically meaningful differences, in terms of safety and efficacy exists.

On Monday, the stock of Biocon closed 2.1 per cent higher at Rs 340.40 from its previous close of Rs 333.55. In just one month, it has delivered ~35 per cent returns from its low level of Rs 252 in mid-March.