On 29 October 2015, the US Food and Drug Administration (FDA) issued a new draft guidance document for non-biological complex drugs (NBCDs). The new draft guidance on liposome drug products replaces draft guidance published in August 2002.
- Home
-
Generics
News
- 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
- Revlimid (lenalidomide) generics launch across Europe
-
Biosimilars
News
- EMA recommends approval of eculizumab biosimilar Epysqli
- New indication for Cosentyx (secukinumab) biological: hidradenitis suppurativa
- Advances for STADA-Xbrane’s Ximluci in Europe, the UK and the US
- Rinvoq approved to treat Crohn’s disease in Europe
Research
- Low switch-back for patients treated with Avsola for IBD
- High mannose glycans in biosimilars and their pharmacokinetic impact
- Biosimilars in Southern European Hospital Markets: barriers and determinants of uptake
- Using infliximab economic evaluations in IBD to inform biosimilar access policies
- MORE EDITORIAL SECTIONS
- Search
Post your comment