Biosimilars and lack of resources
Posted 22/01/2021The results of a survey carried out by the World Health Organization (WHO) in 2019‒2020 [1] revealed that, despite the efforts of the organization in helping...
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EMA recommends approval of adalimumab and insul...
Biosimilars/News |
Posted 22/01/2021
How organizations worldwide are producing HTA r...
Biosimilars/Research |
Posted 22/01/2021
Generics applications under review by EMA – Jan...
Generics/General |
Posted 22/01/2021
Key considerations for payers, employers and pa...
Reports |
Posted 22/01/2021
Canada approves heparin biosimilars Redesca and...
Biosimilars/News |
Posted 22/01/2021
FDA increases transparency of biosimilar applic...
Guidelines |
Posted 22/01/2021
Samsung biosimilars: denosumab clinical trials...
Biosimilars/General |
Posted 22/01/2021
Biosimilars and availability of reference products
Biosimilars/Research |
Posted 15/01/2021
Biosimilars applications under review by EMA –...
Biosimilars/General |
Posted 15/01/2021
EC approval for pegfilgrastim biosimilar Nyvepria
Biosimilars/News |
Posted 15/01/2021
Influence of local policy measures and practice...
Biosimilars/Research |
Posted 15/01/2021
US guidance on proprietary names
Guidelines |
Posted 15/01/2021
Positive phase III results for sintilimab plus...
Biosimilars/Research |
Posted 15/01/2021
Perspectives of prescribing practices in public...
Generics/Research |
Posted 15/01/2021
Celltrion: Takeda acquisitions and new plant de...
Pharma News |
Posted 15/01/2021
Regulatory challenges with biosimilars
Biosimilars/Research |
Posted 08/01/2021
China approves adalimumab copy biological HLX03
Biosimilars/News |
Posted 08/01/2021
More national guidance needed on biosimilars in...
Biosimilars/Research |
Posted 08/01/2021
EMA and FDA accept application for ranibizumab...
Biosimilars/News |
Posted 08/01/2021
Key considerations for providers in the US bios...
Reports |
Posted 08/01/2021
A European pharmaceutical strategy promoting ge...
Generics/General |
Posted 08/01/2021
Phase I study comparing SB8 with reference beva...
Biosimilars/Research |
Posted 08/01/2021
Biosimilars in Australia – a-flagging and susta...
Biosimilars/General |
Posted 08/01/2021
DIA 2021 Global Annual Meeting
Conferences |
Posted 08/01/2021
EMA recommends approval of bevacizumab biosimil...
Biosimilars/News |
Posted 11/12/2020
Scientific, legal and regulatory challenges fac...
Biosimilars/Research |
Posted 11/12/2020
US market trends in oncology/nephrology support...
Reports |
Posted 11/12/2020
New Alvotech partnerships in South Africa and C...
Pharma News |
Posted 11/12/2020
Safety monitoring for immune-modulating biologi...
Biosimilars/Research |
Posted 11/12/2020
Familiarity with substitution of prescription g...
Generics/Research |
Posted 11/12/2020
Biosimilar User Fee Act reauthorization
Guidelines |
Posted 11/12/2020
Biosimilar advances for Samsung Bioepis
Biosimilars/General |
Posted 11/12/2020
EMA accepts application for bevacizumab biosimi...
Biosimilars/News |
Posted 04/12/2020
US biosimilars trends in oncology therapeutics
Reports |
Posted 04/12/2020
Australia approves etanercept and insulin aspar...
Biosimilars/News |
Posted 04/12/2020
FDA issues Q & A on biosimilars
Guidelines |
Posted 04/12/2020
Cost savings after switching to generic tacrolimus
Generics/Research |
Posted 04/12/2020
Real-world data on biosimilars in inflammatory...
Biosimilars/Research |
Posted 04/12/2020
Genentech sues Centus over Avastin biosimilar
Biosimilars/General |
Posted 04/12/2020
Study reveals wide variation in US state drug p...
Biosimilars/Research |
Posted 04/12/2020
FDA accepts application for ranibizumab biosimilar
Biosimilars/News |
Posted 27/11/2020
Asia Pacific countries: future demand for biosi...
Biosimilars/Research |
Posted 27/11/2020
The US biosimilars market in 2020
Reports |
Posted 27/11/2020
Biosimilar toolkit for cancer patients
Biosimilars/General |
Posted 27/11/2020
Biopharmaceuticals and biosimilars: regulatory...
Biosimilars/Research |
Posted 27/11/2020
Equivalent adherence with brand and generic ost...
Generics/Research |
Posted 27/11/2020
FDA new and revised guidances for complex gener...
Guidelines |
Posted 27/11/2020
Pfizer sues Aurobindo and Dr Reddy’s over Ibran...
Generics/General |
Posted 27/11/2020
Canada approves enoxaparin biosimilars Inclunox...
Biosimilars/News |
Posted 20/11/2020
NON-BIOLOGICAL COMPLEX DRUGS
FDA issues final guidance on liposome drug products
Posted 27/04/2018
On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft...
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FDA approves 40 mg follow-on version of glatira...
Non‐Biological Complex Drugs/News |
Posted 09/03/2018
Mylan launches first follow-on glatiramer aceta...
Non‐Biological Complex Drugs/News |
Posted 15/02/2018
Biosimilars and follow-on NBCDs for MS in Europ...
Non‐Biological Complex Drugs/Research |
Posted 19/01/2018
Impax announces FDA approval of follow-on sevel...
Non‐Biological Complex Drugs/News |
Posted 17/11/2017
FDA approves follow-on version of sevelamer
Non‐Biological Complex Drugs/News |
Posted 30/06/2017
Challenges in the regulation of NBCDs
Non‐Biological Complex Drugs/Research |
Posted 12/05/2017
Scientific and regulatory considerations for fo...
Non‐Biological Complex Drugs/Research |
Posted 04/05/2017
Equivalence of complex drug products
Non‐Biological Complex Drugs/Reports |
Posted 14/04/2017
Follow-up studies needed to ensure safety for f...
Non‐Biological Complex Drugs/Research |
Posted 31/03/2017
Warning letter causes delays for follow-on glat...
Non‐Biological Complex Drugs/News |
Posted 17/03/2017
Is the EU ready for non-biological complex drug...
Non‐Biological Complex Drugs/Research |
Posted 03/03/2017
Follow-on versions of glatiramer acetate in Rus...
Non‐Biological Complex Drugs/News |
Posted 24/02/2017
Non-biological complex drugs and pharmacopoeias
Non‐Biological Complex Drugs/Research |
Posted 10/02/2017
In vitro analysis of follow-on versions of seve...
Non‐Biological Complex Drugs/Research |
Posted 18/11/2016
Determining the bioequivalence of follow-on iro...
Non‐Biological Complex Drugs/Reports |
Posted 04/11/2016
FDA to set up abbreviated pathway for complex p...
Non‐Biological Complex Drugs/Polices & Legislation |
Posted 21/10/2016
Challenges in the assessment of ophthalmic emul...
Non‐Biological Complex Drugs/Reports |
Posted 07/10/2016
Cancer lab to evaluate bioequivalence of nanosi...
Non‐Biological Complex Drugs/News |
Posted 23/09/2016
A conference on ‘Equivalence of Complex Drug Pr...
Non‐Biological Complex Drugs/News |
Posted 09/09/2016
Collaboration to introduce nanotechnologies in...
Non‐Biological Complex Drugs/News |
Posted 26/08/2016
Iron carbohydrate follow-on NBCDs
Non‐Biological Complex Drugs/Reports |
Posted 12/08/2016
Rigorous approach used to approve a follow-on v...
Non‐Biological Complex Drugs/Research |
Posted 29/07/2016
US guidelines for follow-on NBCDs
Non‐Biological Complex Drugs/Guidelines |
Posted 10/06/2016
Non-biological complex drugs and their follow-o...
Non‐Biological Complex Drugs/Research |
Posted 03/06/2016
Is a new pathway for NBCDs on the way in the US?
Non‐Biological Complex Drugs/Polices & Legislation |
Posted 27/05/2016
Follow-on glatiramer acetate gains European app...
Non‐Biological Complex Drugs/News |
Posted 13/05/2016
FDA includes follow-on versions in its new cycl...
Non‐Biological Complex Drugs/Guidelines |
Posted 29/04/2016
Switching between originator and follow-on iron...
Non‐Biological Complex Drugs/Research |
Posted 22/04/2016
Follow-on intravenous iron formulations in haem...
Non‐Biological Complex Drugs/Research |
Posted 01/04/2016
Glatiramoid follow-on NBCDs
Non‐Biological Complex Drugs/Reports |
Posted 11/03/2016
FDA includes follow-on versions in its new lipo...
Non‐Biological Complex Drugs/Guidelines |
Posted 26/02/2016
EU guidelines for follow-on NBCDs
Non‐Biological Complex Drugs/Guidelines |
Posted 22/01/2016
GDUFA regulatory priorities for 2016 include co...
Non‐Biological Complex Drugs/Polices & Legislation |
Posted 11/12/2015
Liposomal follow-on NBCDs
Non‐Biological Complex Drugs/Reports |
Posted 11/12/2015
Regulations for follow-on NBCDs
Non‐Biological Complex Drugs/Reports |
Posted 13/11/2015
Status and regulatory issues surrounding follow...
Non‐Biological Complex Drugs/Reports |
Posted 05/11/2015
Follow-on glatiramer acetate (M356) claimed as...
Non‐Biological Complex Drugs/Research |
Posted 05/11/2015
EMA issues reflection paper for follow-on versi...
Non‐Biological Complex Drugs/Guidelines |
Posted 05/11/2015
FDA approves first follow-on version of glatira...
Non‐Biological Complex Drugs/News |
Posted 05/11/2015
Generics News Research General
- Generics applications under review by EMA – Jan...Generics/General | Posted 22/01/2021
- Perspectives of prescribing practices in public...Generics/Research | Posted 15/01/2021
- A European pharmaceutical strategy promoting ge...Generics/General | Posted 08/01/2021
- Familiarity with substitution of prescription g...Generics/Research | Posted 11/12/2020
Biosimilars News Research General
- Samsung biosimilars: denosumab clinical trials...Biosimilars/General | Posted 22/01/2021
- Biosimilars of filgrastimBiosimilars/General | Posted 20/03/2015
- EMA recommends approval of adalimumab and insul...Biosimilars/News | Posted 22/01/2021
- Biosimilars and lack of resourcesBiosimilars/Research | Posted 22/01/2021