FDA opens pathway to biosimilar insulin products

Posted 03/04/2020

On 23 March 2020, insulin products in the US transitioned to a new regulatory pathway which will allow biosimilars to be developed. The change should make in...

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EMA recommends approval of etanercept biosimila... Biosimilars/News | Posted 03/04/2020
Opposition party in Alberta, Canada fights bios... Policies & Legislation | Posted 03/04/2020
Access to biosimilars in China, the EU and the US Biosimilars/General | Posted 03/04/2020
Clinical trials supporting the approval of adal... Biosimilars/Research | Posted 03/04/2020
The Patients Association publishes new advice o... Biosimilars/General | Posted 03/04/2020
Use of anti-TNF biosimilars in the US Biosimilars/Research | Posted 03/04/2020
FDA’s response to coronavirus Pharma News | Posted 03/04/2020
Cost savings from the use of biosimilars in Canada Biosimilars/Research | Posted 27/03/2020
FDA to transition NDAs to BLAs Guidelines | Posted 27/03/2020
Denosumab copy biological accepted for review i... Biosimilars/News | Posted 27/03/2020
Generics outreach programmes should target high... Generics/Research | Posted 27/03/2020
Celltrion/Teva launch trastuzumab biosimilar He... Biosimilars/News | Posted 27/03/2020
Clover starts phase III trial for etanercept co... Biosimilars/Research | Posted 27/03/2020
US oncologist says Medicare should not practice... Biosimilars/General | Posted 27/03/2020
Positive phase I results for Qilu’s bevacizumab... Biosimilars/Research | Posted 20/03/2020
Hospira asks Federal Circuit to reconsider Safe... Policies & Legislation | Posted 20/03/2020
Celltrion launches infliximab biosimilar Remsim... Biosimilars/News | Posted 20/03/2020
PK and PD similarity between pegfilgrastim bios... Biosimilars/Research | Posted 20/03/2020
FDA and FTC collaborate to deter anti-competiti... Biosimilars/General | Posted 20/03/2020
FDA approves lung cancer and anticoagulant gene... Generics/News | Posted 20/03/2020
Arguments against Alberta’s plans to switch pat... Biosimilars/Research | Posted 13/03/2020
Amgen starts phase III trial for aflibercept bi... Biosimilars/News | Posted 13/03/2020
FDA publishes historic drug approvals and searc... Biosimilars/General | Posted 13/03/2020
Tackling the challenge of safe automatic substi... Biosimilars/Research | Posted 13/03/2020
Pharmacopeial standards may increase generics c... Generics/Research | Posted 13/03/2020
Allergan, Ironwood settle Linzess patent dispute Policies & Legislation | Posted 13/03/2020
Biosimilars in the age of patient-centricity Biosimilars/Research | Posted 06/03/2020
FDA accepts application for Mylan’s bevacizumab... Biosimilars/News | Posted 06/03/2020
Ontario becomes third Canadian province to swit... Biosimilars/General | Posted 06/03/2020
Amgen to buy out Japanese partner Astellas Pharma News | Posted 06/03/2020
Delayed entry of buprenorphine generics cost NH... Generics/Research | Posted 06/03/2020
China’s procurement programme cuts drug prices... Policies & Legislation | Posted 06/03/2020
Positive results for Bio-Thera’s bevacizumab co... Biosimilars/Research | Posted 28/02/2020
US patent office rules in Biogen’s favour on Te... Policies & Legislation | Posted 28/02/2020
Chinese company makes copy of patented coronavi... Generics/News | Posted 28/02/2020
Survey reveals attitudes to unauthorized hepati... Generics/Research | Posted 28/02/2020
US lawmakers question FDA on complex generics a... Generics/General | Posted 28/02/2020
Reasons and solutions for the high cost of insu... Biosimilars/Research | Posted 21/02/2020
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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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