Biocon ve Mylan tarafından geliştirilen pelfigrastim biyobenzeri Avustralya’da kullanıma verildi. Avrupa Birliğinde onay alan pelfilgrastim biyobenzeri sayısı altı iken henüz Türkiye’de bu etkin maddeyle onaylanmış biyobenzer bulunmamaktadır.
Biocon Ltd. (BSE code: 532523, NSE: BIOCON) and Mylan N.V. today announced the launch of Fulphila, a biosimilar to Neulasta (pegfilgrastim) in Australia.
Fulphila is approved by the Therapeutic Goods Administration for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infections, as manifested by febrile neutropenia.
Fulphila is now available on the Pharmaceutical Benefits Scheme (PBS).
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 exist.
