Australia approves etanercept and insulin aspart biosimilars

Posted 04/12/2020

Australia’s drug regulator announced in October 2020 the approval of etanercept and insulin aspart biosimilars.

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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
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
Discontinuation following biosimilar switching... Biosimilars/Research | Posted 20/11/2020
Biosimilars trend report 2020 Reports | Posted 20/11/2020
Alberta Biosimilars Initiative: switching polic... Biosimilars/General | Posted 20/11/2020
Global harmonization of GMP standards for biolo... Biosimilars/Research | Posted 20/11/2020
Biden vows to protect Obamacare and increase re... Policies & Legislation | Posted 20/11/2020
China prioritizes drug innovation while increas... Generics/General | Posted 20/11/2020
Teva launches first Truvada and Atripla generic... Generics/News | Posted 20/11/2020
A blueprint for biosimilar assessment without e... Biosimilars/Research | Posted 13/11/2020
Pharmacokinetics and generic drug switching: a... Generics/Research | Posted 13/11/2020
Biosimilar advances for Celltrion Healthcare Biosimilars/General | Posted 13/11/2020
AffaMed and EverInsight merger announced Pharma News | Posted 13/11/2020
EMA recommends approval of Lenalidomide Mylan Generics/News | Posted 13/11/2020
Copy biological approvals in China, compared to... Biosimilars/Research | Posted 13/11/2020
GBMA publishes information resources on biosimi... Biosimilars/General | Posted 13/11/2020
COVID-19 vaccine progress and FDA approvals for... Generics/News | Posted 13/11/2020
Rationale for biosimilar assessment without eff... Biosimilars/Research | Posted 06/11/2020
Innovent and Eli Lilly receive approval for rit... Biosimilars/News | Posted 06/11/2020
UK releases post-Brexit biosimilar guidelines Guidelines | Posted 06/11/2020
Shared decision-making and the transition to bi... Biosimilars/Research | Posted 06/11/2020
Brazil sees a COVID vaccine setback but treatme... Generics/General | Posted 06/11/2020
Changes to New Zealand law for quick access to... Policies & Legislation | Posted 06/11/2020
International Psoriasis Council releases consen... Biosimilars/General | Posted 30/10/2020
Canada approves trastuzumab biosimilar Kanjinti Biosimilars/News | Posted 30/10/2020
Role of efficacy trials in biosimilar assessmen... Biosimilars/Research | Posted 30/10/2020
Perceptions of biosimilars and switching in Ara... Biosimilars/Research | Posted 30/10/2020
AbbVie accused of anticompetitive tactics to st... Policies & Legislation | Posted 30/10/2020
FDA approves Glenmark and Cipla generics Generics/News | Posted 30/10/2020
EMA accepts application for ranibizumab biosimi... Biosimilars/News | Posted 23/10/2020
Biosimilar assessments: do we need efficacy tri... Biosimilars/Research | Posted 23/10/2020
Biopharmaceuticals and biosimilars: manufacturi... Biosimilars/Research | Posted 23/10/2020
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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 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
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