Teva Pharmaceutical Industries announced on 30 September 2010 that the FDA has requested additional information for the Biologic License Application (BLA) for Neutroval (filgrastim), its biosimilar version of Amgen’s Neupogen (granulocyte colony-stimulating factor [G-CSF]). This action by the FDA will effectively delay any launch of the company’s first generic biotech drug in the US.
- INICIO
-
Genéricos
Novedades
- FDA approves generic teriparatide and levetiracetam
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
Investigación
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
- Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
-
Biosimilares
Novedades
- Dr Reddy's launches bevacizumab biosimilar Versavo in the UK
- EMA recommends approval of ustekinumab biosimilar Pyzchiva
- La FDA aprueba el biosimilar intercambiable de adalimumab Simlandi
- EC approval of ranibizumab biosimilar Rimmyrah
Investigación
- Cuestionando la necesidad de evaluaciones de sensibilidad étnica para anticuerpos monoclonales biosimilares
- ANVISA's role in biosimilar medicine regulation and innovation promotion
- Infliximab discontinuation in patients with originator retransition vs biosimilar continuation
- Biological therapies for psoriasis: evaluating durability and persistent benefits
- MORE EDITORIAL SECTIONS
- Search
Comments (0)
Post your comment