FDA approval for Amgen’s infliximab biosimilar Avsola
Posted 13/12/2019US-based biotech giant Amgen announced on 6 December 2019 that it had received approval from the US Food and Drug Administration (FDA) for its inflixima...
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Canadian gastroenterologists issue biosimilar p...
Biosimilars/General |
Posted 13/12/2019
Bio-Thera gains Chinese approval for adalimumab...
Biosimilars/News |
Posted 13/12/2019
Bill to stop misuse of Citizen Petitions advanc...
Policies & Legislation |
Posted 13/12/2019
The impact of generics regulation in Brazil
Generics/Research |
Posted 13/12/2019
Pharmacists must be ready to take the lead on b...
Biosimilars/Research |
Posted 13/12/2019
Ontario proposes regulatory changes to simplify...
Generics/General |
Posted 13/12/2019
FDA issues updated guidance on implementing GDU...
Guidelines |
Posted 13/12/2019
Australia approves five biosimilars since June...
Biosimilars/News |
Posted 06/12/2019
Health Canada publishes biosimilars fact sheet
Guidelines |
Posted 06/12/2019
How to support a viable US biosimilars market
Reports |
Posted 06/12/2019
Use of pegfilgrastim copy biological Mecapegfil...
Biosimilars/Research |
Posted 06/12/2019
WHO prequalifies antiparasitic API
Generics/General |
Posted 06/12/2019
Phase III trials started for bevacizumab and na...
Biosimilars/News |
Posted 06/12/2019
Samsung Bioepis expands biosimilars agreement w...
Pharma News |
Posted 06/12/2019
EMA recommends approval for two new generics
Generics/News |
Posted 06/12/2019
FDA issues draft guidance for insulin biosimilars
Guidelines |
Posted 29/11/2019
EC approval for subcutaneous infliximab biosimi...
Biosimilars/News |
Posted 29/11/2019
WHO launches insulin prequalification programme
Biosimilars/General |
Posted 29/11/2019
Biosimilar education for Canadian nurses
Biosimilars/Research |
Posted 29/11/2019
Lupin to launch etanercept and pegfilgrastim b...
Biosimilars/News |
Posted 29/11/2019
The sluggish US biosimilars market
Reports |
Posted 29/11/2019
FDA generics approvals increasing but not for a...
Generics/Research |
Posted 29/11/2019
Alvotech signs agreements with Stada and Yas Ho...
Pharma News |
Posted 29/11/2019
Concerns raised as Canada’s Alberta plans to sw...
Policies & Legislation |
Posted 22/11/2019
FDA approves adalimumab biosimilar Abrilada
Biosimilars/News |
Posted 22/11/2019
Varied approach to interchangeability across th...
Reports |
Posted 22/11/2019
Qilu starts phase III trial for denosumab copy...
Biosimilars/News |
Posted 22/11/2019
Brazilian efficacy and safety data for biosimil...
Biosimilars/Research |
Posted 22/11/2019
Lupin to sell its Japanese arm and Sandoz to ac...
Pharma News |
Posted 22/11/2019
FDA identifies causes of drug shortages, recomm...
Generics/General |
Posted 22/11/2019
Dubai’s LIFEPharma signs historic agreement wit...
Generics/News |
Posted 22/11/2019
Biologicals and biosimilar use in Asian patient...
Biosimilars/Research |
Posted 15/11/2019
Adalimumab copy biological accepted for review...
Biosimilars/News |
Posted 15/11/2019
Oncology pharmacists issue position statement o...
Biosimilars/General |
Posted 15/11/2019
Phase I trials started for aflibercept and uste...
Biosimilars/News |
Posted 15/11/2019
Designing fit-for-purpose biosimilar studies
Reports |
Posted 15/11/2019
Samsung reveals positive trial results for beva...
Biosimilars/Research |
Posted 15/11/2019
Safety of generics in US questioned
Generics/Research |
Posted 15/11/2019
Alvogen gains exclusive rights to market parath...
Pharma News |
Posted 15/11/2019
Medicines for Europe 18th Biosimilar Medicines...
Conferences |
Posted 15/11/2019
Terrapinn Festival of Biologics USA 2020
Conferences |
Posted 15/11/2019
Medicines for Europe 16th Legal Affairs Confere...
Conferences |
Posted 15/11/2019
Uptake of biosimilars in different countries va...
Reports |
Posted 08/11/2019
FDA approves pegfilgrastim biosimilar Ziextenzo
Biosimilars/News |
Posted 04/11/2019
EC publishes biosimilar information for healthc...
Guidelines |
Posted 08/11/2019
Biosimilar regulation in the Middle East
Reports |
Posted 08/11/2019
Clinical data requirements for biosimilars in t...
Biosimilars/Research |
Posted 08/11/2019
Generics transition brings economic benefits to...
Generics/Research |
Posted 08/11/2019
Tanvex BioPharma’s filgrastim biosimilar comes...
Biosimilars/News |
Posted 08/11/2019
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 05/05/2017
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
- The impact of generics regulation in BrazilGenerics/Research | Posted 13/12/2019
- Ontario proposes regulatory changes to simplify...Generics/General | Posted 13/12/2019
- EMA recommends approval for two new genericsGenerics/News | Posted 06/12/2019
- FDA generics approvals increasing but not for a...Generics/Research | Posted 29/11/2019
Biosimilars News Research General
- FDA approval for Amgen’s infliximab biosimilar...Biosimilars/News | Posted 13/12/2019
- Canadian gastroenterologists issue biosimilar p...Biosimilars/General | Posted 13/12/2019
- Bio-Thera gains Chinese approval for adalimumab...Biosimilars/News | Posted 13/12/2019
- Pharmacists must be ready to take the lead on b...Biosimilars/Research | Posted 13/12/2019