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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...

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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
Price controls, competition and tendering for b... Reports | 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
Korean biosimilars makers pipelines and expansion Pharma News | Posted 26/02/2021
AIFA updates the Transparency Lists for generics Generics/General | Posted 26/02/2021
How do the biosimilar markets in the US and Eur... Reports | Posted 19/02/2021
Canada approves infliximab biosimilar Remsima SC Biosimilars/News | Posted 19/02/2021
EU MedSoc 2016 Cover V15L30DG
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
UK’s MHRA publishes guidance on licensing biosi... Guidelines | 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
EU MedSoc 2016 Cover V15L30DG
What can the US learn from the European biosimi... Reports | Posted 12/02/2021
Innovent makes deal for bevacizumab copy biolog... Pharma 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
FDA publishes report on areas of regulatory foc... Reports | Posted 12/02/2021
Canada approves insulin aspart biosimilar Trurapi Biosimilars/News | Posted 12/02/2021
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Regulatory issues related to quality of biosimi... Biosimilars/Research | Posted 05/02/2021
FDA includes generics of complex drugs in regul... Reports | 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
Biosimilars policy considerations in the US Reports | 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
Partnerships formed and extended between Isu Ab... Pharma News | Posted 05/02/2021
Top 10 most read GaBI Online articles in 2020 Pharma News | Posted 29/01/2021
Interchangeability V18K30
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
US biosimilars reimbursement: Medicare and 340B Reports | Posted 29/01/2021
Italy publishes new guidelines on pricing and r... Guidelines | 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
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
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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
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