Mylan and Biocon Launch Pegfilgrastim Biosimilar in Australia

Mylan and Biocon have announced the launch of their pegfilgrastim biosimilar (Fulphila) in Australia.

The product, a biosimilar to Amgen’s Neulasta, was launched in the United States in 2018.

Fulphila, for the treatment of patients with cancer following chemotherapy, was approved by Australia’s Therapeutic Goods Administration. The agent helps to shorten the duration of severe neutropenia and reduce the incidence of infections, as manifested by febrile neutropenia.

Fulphilia is the third biosimilar to be commercialized in Australia by the partnership between Mylan and Biocon, according to Sylvain Vigneault, the Australia country manager for Mylan.

“Biosimilars ensure patients have timely and affordable access to quality, safe, and effective treatments in a way that is sustainable,” he said.

The Australian government has endeavored to get biosimilars into circulation through the Biosimilar Awareness Initiative, established in 2015, and in 2018 the country established a $5 million grant through the Generic and Biosimilar Medicines Association to improve education on biosimilars and activities that promote appropriate prescribing, dispensing, and use of biosimilar medications.

The country has approved 26 biosimilars since 2010, including 3 other pegfilgrastim biosimilars and 5 trastuzumab products besides the reference Herceptin. Fifteen of those biosimilars are subsidized by the country’s Pharmaceutical Benefits Scheme.

Mylan has a portfolio of 20 biosimilar and insulin analog products in development or on the market.

Fulphilia was codeveloped by Biocon and Mylan and was the first biosimilar pegfilgrastim to be approved in the United States. The biosimilar has received regulatory approval in more than 30 countries, according to Biocon.

Biocon has a pipeline of 28 molecules, including 11 with Mylan and a number with Sandoz, and is also developing agents independently. The company has a therapeutic armamentarium that includes agents for diabetes, cancer, immunology, dermatology, ophthalmology, neurology, rheumatology, and inflammatory diseases.

Last year, Biocon and Mylan launched their trastuzumab biosimilar (Ogivri) on the Australian market. It became the first trastuzumab biosimilar to appear in the Australian marketplace.

Also last year, Biocon and Mylan launched their biosimilar insulin glargine, Semglee, in Australia.