Regulatory principles for biosimilar monoclonal antibodies

posted 18/04/2014

It is sometimes argued that there is less clinical evidence for biosimilars. However, Tsiftsoglou and co-authors pointed out that European Medicines Agency (...

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Long-term safety study of biosimilar anti-TNF i... Biosimilars/News | Posted 18/04/2014
Positive impact of a value-based approach to he... Generics/Research | Posted 18/04/2014
Results of clinical trials in Europe to be made... Generics/General | Posted 18/04/2014
Sun Pharma to acquire Ranbaxy creating 5th larg... Generics/News | Posted 18/04/2014
World Biosimilar Congress 2014 Conferences | Posted 18/04/2014
WHO investigates use of a biological qualifier... Biosimilars/General | Posted 11/04/2014
Quality by design for biosimilars Biosimilars/Research | Posted 11/04/2014
FDA discredits study claiming foreign generics... Generics/General | Posted 11/04/2014
Australian price cuts make PBS affordable Policies & Legislation | Posted 11/04/2014
Actavis buys Thai generics company Pharma News | Posted 11/04/2014
Celltrion starts phase III biosimilar trastuzum... Biosimilars/News | Posted 11/04/2014
Taiwan TWi gains FDA approval for generic nifed... Generics/News | Posted 11/04/2014
Cost savings to be made by switching to Zarzio Biosimilars/Research | Posted 04/04/2014
Bill proposes extension of patents for new uses... Policies & Legislation | Posted 04/04/2014
Cost savings and use of generics in Europe Reports | Posted 04/04/2014
Prescribers, pharmacists and patients in Turkey... Generics/Research | Posted 04/04/2014
Alvotech and Finesse enter into biosimilars col... Biosimilars/News | Posted 04/04/2014
The generics market in China Reports | Posted 04/04/2014
The non-financial benefits of generics substitu... Generics/Research | Posted 28/03/2014
Indiana biosimilars substitution bill becomes law Policies & Legislation | Posted 28/03/2014
Biosimilar filgrastim gains Japanese approval Biosimilars/News | Posted 28/03/2014
EGA calls for removal of competition and trade... Generics/General | Posted 28/03/2014
Celecoxib generics could come sooner than expected Generics/News | Posted 28/03/2014
Obama pushes for 7-year exclusivity for biologi... Policies & Legislation | Posted 21/03/2014
Are biosimilars worth it? Biosimilars/Research | Posted 21/03/2014
GPhA proposes using manufacturer names to disti... Biosimilars/General | Posted 21/03/2014
FDA increases oversight of drug safety in India Generics/General | Posted 21/03/2014
Proposal in Brazil to exempt medicines from tax Policies & Legislation | Posted 21/03/2014
Long-acting G-CSF lipegfilgrastim launched in UK Biosimilars/News | Posted 21/03/2014
Indian generics makers face US recalls Generics/News | Posted 21/03/2014
Generics contribution to availability of essent... Generics/Research | Posted 14/03/2014
How safe is Zarzio after five years’ clinical e... Biosimilars/Research | Posted 14/03/2014
Brand-name drugs also cut healthcare costs Generics/General | Posted 14/03/2014
Amgen starts another phase III trial for biosim... Biosimilars/News | Posted 14/03/2014
FDA approves generic osteoporosis drug Generics/News | Posted 14/03/2014
Biosimilars approved in South Korea Biosimilars/General | Posted 14/03/2014
EMA and FDA extend quality collaboration Policies & Legislation | Posted 14/03/2014
Protein aggregation and the generation of immun... Biosimilars/Research | Posted 14/03/2014
Use of generic cardiovascular drugs in China Generics/Research | Posted 07/03/2014

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