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A positive outlook for the US biosimilars market

 Posted 30/04/2021

The US is keeping pace with the European pioneers of biosimilars approvals, reveals an article published in GaBI Journal [1].

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LG Chem gains approval for adalimumab biosimila... Biosimilars/News | Posted 30/04/2021
The future of copy biologicals in China Reports | Posted 30/04/2021
Rheumatoid arthritis treatments in Australia Biosimilars/General | Posted 30/04/2021
Huons Lab and PanGen Biotech to develop denosum... Pharma News | Posted 30/04/2021
Expanding access to trastuzumab biological trea... Biosimilars/Research | Posted 30/04/2021
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Colorado to import drugs from Canada and beyond Policies & Legislation | Posted 30/04/2021
Generics in India Generics/General | Posted 30/04/2021
CADTH summarizes evidence on switching to etane... Biosimilars/Research | Posted 23/04/2021
EC approval for bevacizumab biosimilar Alymsys/... Biosimilars/News | Posted 23/04/2021
Challenges facing copy biologicals in China Reports | Posted 23/04/2021
Relieving the economic burden on EU healthcare... Biosimilars/Research | Posted 23/04/2021
Turkey 2016 COVER V16E31DG
PlantForm and partners in Brazil to develop pem... Pharma News | Posted 23/04/2021
Biosimilars of enoxaparin sodium Biosimilars/General | Posted 23/04/2021
Tentative US approval for Symbicort generic Generics/News | Posted 23/04/2021
Federal Court maintains decision on infliximab... Policies & Legislation | Posted 23/04/2021
Characteristics associated with biosimilar use... Biosimilars/Research | Posted 16/04/2021
Switching V19A17
British Columbia adds adalimumab to biosimilar... Biosimilars/General | Posted 16/04/2021
Biocon partners with Libbs for the sale of gene... Pharma News | Posted 16/04/2021
Biosimilars in the treatment of psoriasis Biosimilars/Research | Posted 16/04/2021
Advances for Formycon and Alteogen’s eye diseas... Biosimilars/News | Posted 16/04/2021
Teva not liable in US due to FDCA implied preem... Policies & Legislation | Posted 16/04/2021
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Investment increasing pipeline of copy biologic... Reports | Posted 16/04/2021
US$1.2 FDA contract for generic drug computatio... Generics/General | Posted 16/04/2021
Adalimumab biosimilar FKB327 causes less pain t... Biosimilars/Research | Posted 09/04/2021
New partnerships for Cipla and Samsung Bioepis Pharma News | Posted 09/04/2021
Biosimilars regulation, clinical trials, approv... Biosimilars/Research | Posted 09/04/2021
FDA accepts application for adalimumab biosimil... Biosimilars/News | Posted 09/04/2021
Improved regulation favouring copy biologicals... Reports | Posted 09/04/2021
Biosimilars of ustekinumab Biosimilars/General | Posted 09/04/2021
Dispensing branded drugs costs Medicare over a... Generics/Research | Posted 09/04/2021
China improves generics injection consistency e... Policies & Legislation | Posted 09/04/2021
Etanercept biosimilar injection pen, YLB113, co... Biosimilars/Research | Posted 02/04/2021
Pfizer sells Chinese copy biologicals plant to... Pharma News | Posted 02/04/2021
Technological approaches to drug repurposing fo... Generics/Research | Posted 02/04/2021
Samsung Bioepis and Eden Biologics announce new... Biosimilars/Research | Posted 02/04/2021
Patent expiries may drive development of copy b... Reports | Posted 02/04/2021
Australian and Indian approval for teriparatide... Biosimilars/News | Posted 02/04/2021
Biosimilars of aflibercept Biosimilars/General | Posted 02/04/2021
EMA recommends approval of abiraterone and thio... Generics/News | Posted 02/04/2021
Biosimilars in Europe: prescriber survey Biosimilars/Research | Posted 26/03/2021
Argentina approves bevacizumab similar biologic... Biosimilars/News | Posted 26/03/2021
Cancer driving the need for copy biologicals in... Reports | Posted 26/03/2021
EC approval for insulin aspart biosimilar Kixelle Biosimilars/News | Posted 26/03/2021
Public health impact of using biosimilars and r... Biosimilars/Research | Posted 26/03/2021
Drug regulators need to evolve with biosimilars Reports | Posted 26/03/2021
Italy simplifies over-the-counter generics pric... Policies & Legislation | Posted 26/03/2021
Teva and Sandoz launch new generics Generics/News | Posted 26/03/2021
Pelmeg developed with aid of regulatory reform Biosimilars/Research | Posted 19/03/2021
IVM releases toolbox on how to switch patients... Biosimilars/General | Posted 19/03/2021
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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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