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Biosimilars: implications for oncologists

Posted 13/07/2018

In 2015, the US Food and Drug Administration (FDA) approved its first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor...

Pfizer gains Japanese approval for infliximab b... Biosimilars/News | Posted 13/07/2018

Analytical consideration in demonstrating simil... Reports | Posted 13/07/2018

Generic sofosbuvir and daclatasvir bioequivalen... Generics/Research | Posted 13/07/2018

Hatch aims to promote biosimilars and generics... Policies & Legislation | Posted 13/07/2018

Positive results for infliximab and trastuzumab... Biosimilars/Research | Posted 13/07/2018

US pharmacies sue J&J for stifling inflixim... Biosimilars/General | Posted 13/07/2018

FDA approves first Suboxone generics for opioid... Generics/News | Posted 13/07/2018

FDA withdraws biosimilar statistical guidance Guidelines | Posted 06/07/2018

Biosimilars applications under review by EMA –... Biosimilars/General | Posted 06/07/2018

Biosimilarity testing using very low doses of r... Biosimilars/Research | Posted 06/07/2018

FDA rejects botulinum toxin biosimilar from Evolus Biosimilars/News | Posted 06/07/2018

Analytical similarity for biosimilars Reports | Posted 06/07/2018

China to extend drug patents and tackle anticom... Policies & Legislation | Posted 06/07/2018

UK investigates price increases for generics Generics/General | Posted 06/07/2018

Pfenex makes biosimilar deals with Alvogen and... Pharma News | Posted 06/07/2018

Medicines for Europe 2nd Value Added Medicines... Conferences | Posted 06/07/2018

SMi 5th Annual Biosimilars USA Conference 2018 Conferences | Posted 06/07/2018

Biosimilars development moving to Asia Reports | Posted 29/06/2018

FDA rejects Amgen’s trastuzumab biosimilar Biosimilars/News | Posted 29/06/2018

Biosimilar insulins have same efficacy and safe... Biosimilars/Research | Posted 29/06/2018

Biosimilar infliximab blocked in Australia Biosimilars/General | Posted 29/06/2018

Savings with use of biosimilar trastuzumab for... Biosimilars/Research | Posted 29/06/2018

Generic clopidogrel non-inferior to Plavix in a... Generics/Research | Posted 29/06/2018

Amneal and mAbxience make deal for bevacizumab... Pharma News | Posted 29/06/2018

FDA issues draft guidance on biosimilar meetings Guidelines | Posted 29/06/2018

DIA Biosimilars Conference 2018 Conferences | Posted 29/06/2018

Terrapinn World Biosimilar Congress 2018 Conferences | Posted 29/06/2018

Biosimilars and the role of regulatory authorities Biosimilars/Research | Posted 22/06/2018

Celltrion resubmits biosimilar trastuzumab to FDA Biosimilars/News | Posted 22/06/2018

Developing biosimilars Reports | Posted 22/06/2018

Efficacy, safety and immunogenicity of adalimum... Biosimilars/Research | Posted 22/06/2018

FDA publishes list of companies that block gene... Generics/General | Posted 22/06/2018

Strides and Apotex to merge Australian generics... Pharma News | Posted 22/06/2018

US approval for prostate cancer formulation and... Generics/News | Posted 22/06/2018

Spanish associations sign biosimilars collabora... Biosimilars/General | Posted 22/06/2018

Life cycle and regulatory evaluation of biosimi... Biosimilars/Research | Posted 15/06/2018

Update on the biosimilar programme in the US Reports | Posted 15/06/2018

Etanercept biosimilars submitted to EMA and lau... Biosimilars/News | Posted 15/06/2018

EC proposes waiver of SPCs to allow manufacturi... Policies & Legislation | Posted 15/06/2018

Doctors’ perceptions of generics in Guadeloupe... Generics/Research | Posted 15/06/2018

WuXi Biologics expands its biologicals manufact... Biosimilars/General | Posted 15/06/2018

Aurobindo and Lannett expand their generics por... Generics/News | Posted 15/06/2018

FDA issues guidance on quality considerations f... Guidelines | Posted 15/06/2018

Regulating biosimilars throughout their life cycle Biosimilars/Research | Posted 08/06/2018

EMA approves adalimumab and trastuzumab biosimi... Biosimilars/News | Posted 08/06/2018

FDA approval for pegfilgrastim biosimilar Fulphila Biosimilars/News | Posted 08/06/2018

Generics market failures and non-profit manufac... Generics/Research | Posted 08/06/2018

EMA studying pharmacovigilance for biologicals... Reports | Posted 08/06/2018

FDA to boost generics and change drug rebates t... Generics/General | Posted 08/06/2018

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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...

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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Country Focus

First posted: 11 May 2010 Concerning the views on biosimilars in The Ne... Posted 16/04/2015
First posted: 11 April 2012 Concerning the generics market in Austria,... Posted 16/04/2015

All countries

Generics News Research General

UK investigates price increases for genericsGenerics/General | Posted 06/07/2018
Generic sofosbuvir and daclatasvir bioequivalen...Generics/Research | Posted 13/07/2018
FDA approves first Suboxone generics for opioid...Generics/News | Posted 13/07/2018
Generic clopidogrel non-inferior to Plavix in a...Generics/Research | Posted 29/06/2018

US pharmacies sue J&J for stifling inflixim...Biosimilars/General | Posted 13/07/2018
Biosimilars of bevacizumabBiosimilars/General | Posted 02/06/2014
Biosimilars of epoetin alfaBiosimilars/General | Posted 13/06/2014
Biosimilars applications under review by EMA –...Biosimilars/General | Posted 06/07/2018

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