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How local policy measures and practices influence originator biological and biosimilar market dynamics in Sweden

 Posted 21/06/2019

The licensing of biologicals, including biosimilars, in Europe is centralized via the European Medicines Agency (EMA). Subsequently, individual European Memb...

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FDA approves trastuzumab biosimilar Kanjinti Biosimilars/News | Posted 21/06/2019
Recommendations for similar biotherapeutic prod... Biosimilars/General | Posted 21/06/2019
Alteogen gains approval to start aflibercept bi... Biosimilars/News | Posted 21/06/2019
Switching V19A17
Canada’s British Columbia to switch patients t... Policies & Legislation | Posted 21/06/2019
Positive phase I results for Bio-Thera’s bevaci... Biosimilars/Research | Posted 21/06/2019
Boehringer Ingelheim finally signs licensing de... Pharma News | Posted 21/06/2019
FDA approval for Unichem Lab’s hydrochloride me... Generics/News | Posted 21/06/2019
Is switching to biosimilar infliximab safe? Biosimilars/Research | Posted 14/06/2019
Trastuzumab biosimilar from Prestige accepted f... Biosimilars/News | Posted 14/06/2019
Eli Lilly launches lower-priced insulin lispro Biosimilars/General | Posted 14/06/2019
Brazilian approval for trastuzumab follow-on bi... Biosimilars/News | Posted 14/06/2019
Comments on FDA’s plans to transition insulin p... Guidelines | Posted 14/06/2019
UnitedHealthcare to prefer brand-name pegfilgra... Biosimilars/General | Posted 14/06/2019
Sandoz’s rosuvastatin approved under China’s ne... Biosimilars/News | Posted 14/06/2019
Bulgaria and Cyprus added to EU-US mutual recog... Policies & Legislation | Posted 14/06/2019
Biosimilars to replace older biologicals for IBD Biosimilars/Research | Posted 07/06/2019
Trastuzumab biosimilar Ogivri approved in Canada Biosimilars/News | Posted 07/06/2019
Switching V19A17
Irish hospitals to get incentives to switch pat... Biosimilars/General | Posted 07/06/2019
Brazilian approval for trastuzumab follow-on bi... Biosimilars/News | Posted 07/06/2019
Dramatic price reduction of trastuzumab in Mala... Biosimilars/General | Posted 07/06/2019
US considering eight years protection for biolo... Policies & Legislation | Posted 07/06/2019
Sandoz and EirGenix make deal for trastuzumab b... Pharma News | Posted 07/06/2019
Pharmacy benefit managers use spread pricing to... Generics/General | Posted 07/06/2019
FDA issues guidance on quality-related consider... Guidelines | Posted 31/05/2019
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Factors contributing to long-term sustainabilit... Reports | Posted 31/05/2019
FDA’s Orange and Purple Books to be improved an... Policies & Legislation | Posted 31/05/2019
NeuClone to start phase I trial for ustekinumab... Biosimilars/News | Posted 31/05/2019
Settlement for Udenyca and win for Zarxio Biosimilars/General | Posted 31/05/2019
Positive results for rituximab copy biological... Biosimilars/Research | Posted 31/05/2019
Biocon/Mylan gain global rights to adalimumab b... Biosimilars/General | Posted 31/05/2019
Teva launches generic testosterone gel and over... Generics/News | Posted 31/05/2019
GaBI J 2012-1 Cover V12b13PA
GaBI Journal is the number one journal publishi... Biosimilars/Research | Posted 24/05/2019
The level of biosimilars competition in Europe... Reports | Posted 24/05/2019
Stakeholders question FDA’s guidance on naming... Guidelines | Posted 24/05/2019
New biosimilar guide for pharmacists in Australia Policies & Legislation | Posted 24/05/2019
Recommendations published by Canadian breast ca... Biosimilars/General | Posted 24/05/2019
Russian approval for non-originator eculizumab Biosimilars/News | Posted 24/05/2019
BiosanaPharma starts phase I trial for omalizum... Biosimilars/Research | Posted 24/05/2019
Adherence to generic versus brand-name statins... Generics/Research | Posted 24/05/2019
Interchangeability V18K30
FDA issues final guidance on interchangeable bi... Guidelines | Posted 17/05/2019
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Biosimilars market and opportunities in Europe Reports | Posted 17/05/2019
Canadian organizations collaborate to improve b... Biosimilars/General | Posted 17/05/2019
Multi-state lawsuit alleges widespread generic... Generics/General | Posted 17/05/2019
Adalimumab biosimilar Idacio launched in Germany Biosimilars/News | Posted 17/05/2019
ASCO/ASH give recommendations for biosimilar ESAs Biosimilars/Research | Posted 17/05/2019
EMA approves hypertension and Parkinson’s generics Generics/News | Posted 17/05/2019
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Alvotech signs agreement for ustekinumab biosim... Pharma News | Posted 17/05/2019
SMi 10th Annual Biosimilars and Biologics Confe... Conferences | Posted 17/05/2019
Biosimilars education still needed for US and E... Biosimilars/Research | Posted 10/05/2019
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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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