Collaboration between regulatory authorities for biosimilars

Posted 26/02/2021

A survey carried out by the World Health Organization (WHO) in 2019‒2020 highlighted the need for collaboration between regulatory authorities in order to ex...

Biosimilar approvals and launches in the US Biosimilars/General | Posted 26/02/2021
FDA accepts application for bevacizumab biosimi... Biosimilars/News | Posted 26/02/2021
Approving generics of polymer-based parenteral... Generics/Research | Posted 26/02/2021
Improving biosimilar use in clinical practice Biosimilars/Research | Posted 26/02/2021
AIFA updates the Transparency Lists for generics Generics/General | Posted 26/02/2021
Canada approves infliximab biosimilar Remsima SC Biosimilars/News | Posted 19/02/2021
Improving stakeholder understanding about biosi... Biosimilars/Research | Posted 19/02/2021
Innovent starts phase II trial for ipilimumab c... Biosimilars/News | Posted 19/02/2021
Adherence improves long-term prognosis and medi... Generics/Research | Posted 19/02/2021
Biosimilar approvals and patent litigation in t... Biosimilars/General | Posted 19/02/2021
Problems with the tiered pricing policy for gen... Policies & Legislation | Posted 19/02/2021
Interchangeability, naming and pharmacovigilanc... Biosimilars/Research | Posted 12/02/2021
EMA recommends approval of adalimumab biosimila... Biosimilars/News | Posted 12/02/2021
Improving the understanding of biosimilars thro... Biosimilars/Research | Posted 12/02/2021
Anti-competitive strategic patenting by pharmac... Generics/Research | Posted 12/02/2021
Canada approves insulin aspart biosimilar Trurapi Biosimilars/News | Posted 12/02/2021
Regulatory issues related to quality of biosimi... Biosimilars/Research | Posted 05/02/2021
China extends indications for adalimumab and be... Biosimilars/News | Posted 05/02/2021
Understanding and minimizing injection-site pai... Biosimilars/Research | Posted 05/02/2021
Canada approves three teriparatide biosimilars... Biosimilars/News | Posted 05/02/2021
Biocon and Lupin launch generic tacrolimus caps... Generics/News | Posted 05/02/2021
Top 10 most read GaBI Online articles in 2020 Pharma News | Posted 29/01/2021
Clinical evidence for interchangeability of bio... Biosimilars/Research | Posted 29/01/2021
EMA recommends approval of insulin aspart biosi... Biosimilars/News | Posted 29/01/2021
FDA approves rituximab biosimilar Riabni Biosimilars/News | Posted 29/01/2021
New generics company to offer low-cost versions... Generics/General | Posted 29/01/2021
EMA and EU medicines regulatory joint five-year... Policies & Legislation | Posted 29/01/2021
Biosimilars and lack of resources Biosimilars/Research | Posted 22/01/2021
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
Canada approves heparin biosimilars Redesca and... Biosimilars/News | 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


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...


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

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