Expediting FDA approvals for biosimilars

Posted 19/10/2018

A number of recommendations for the US Food and Drug Administration (FDA) to simplify biosimilar licensing laws, and thus make biosimilars more accessible, a...

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FDA advisers recommend approval of rituximab bi... Biosimilars/News | Posted 19/10/2018
Sustainability of biosimilars in Europe Reports | Posted 19/10/2018
Platelet reactivity with generic and brand-name... Generics/Research | Posted 19/10/2018
Australia encouraging biosimilars and mandating... Policies & Legislation | Posted 19/10/2018
Teva launches generic tadalafil but delays laun... Generics/News | Posted 19/10/2018
Phase III trial for subcutaneous Remsima completed Biosimilars/Research | Posted 19/10/2018
Comments on FDA’s public meeting on biosimilars Biosimilars/General | Posted 12/10/2018
Two darbepoetin alfa biosimilars submitted to J... Biosimilars/News | Posted 12/10/2018
Reasons for switching to biosimilars and immuno... Biosimilars/Research | Posted 12/10/2018
Free prescriptions do not always increase use o... Generics/Research | Posted 12/10/2018
European approval for fluticasone/salmeterol an... Generics/News | Posted 12/10/2018
FDA approves first drug via Competitive Generic... Generics/General | Posted 12/10/2018
EMA aims to improve the availability of medicin... Policies & Legislation | Posted 12/10/2018
Stakeholder perspectives on biosimilars in onco... Biosimilars/Research | Posted 05/10/2018
EC approval for adalimumab and pegfilgrastim bi... Biosimilars/News | Posted 05/10/2018
Limited distribution networks found to be antic... Generics/Research | Posted 05/10/2018
Biosimilars no longer eligible for parallel pro... Policies & Legislation | Posted 05/10/2018
Hospitals launch non-profit generics company Generics/General | Posted 05/10/2018
Pharmacokinetics of CT-P6 in patients with HER2... Biosimilars/Research | Posted 05/10/2018
Biocon’s biosimilars plant gains clearance from... Biosimilars/General | Posted 05/10/2018
Bioequivalence of bevacizumab biosimilar (BEVZ9... Biosimilars/Research | Posted 28/09/2018
EMA approves pegfilgrastim biosimilars Fulphila... Biosimilars/News | Posted 28/09/2018
Generic hepatitis drug effective in patients wi... Generics/Research | Posted 28/09/2018
Adalimumab copy biologicals accepted for review... Biosimilars/News | Posted 28/09/2018
Recommendations for biosimilars in rheumatology... Biosimilars/Research | Posted 28/09/2018
Samsung Bioepis sued over trastuzumab biosimila... Biosimilars/General | Posted 28/09/2018
FDA approves first EpiPen generic amid shortages Generics/News | Posted 28/09/2018
Improving understanding of biotherapeutics and... Biosimilars/General | Posted 21/09/2018
Mexico trade deal impacts biologicals exclusivity Policies & Legislation | Posted 21/09/2018
Selection of quality attributes and test method... Biosimilars/Research | Posted 21/09/2018
Factors influencing the use of trade and generi... Generics/Research | Posted 21/09/2018
Adalimumab and trastuzumab biosimilars gain EC... Biosimilars/News | Posted 21/09/2018
Increase in use of biosimilar rituximab for NHL... Biosimilars/Research | Posted 21/09/2018
Novartis divests dermatology and generic oral s... Generics/General | Posted 21/09/2018
WHO asks for comments on new biosimilar Q&A Guidelines | Posted 14/09/2018
Japan approves first darbepoetin alfa biosimilar Biosimilars/News | Posted 14/09/2018
Hospital use of generic drugs increases adoptio... Generics/Research | Posted 14/09/2018
Extension of indications and manufacturing appr... Biosimilars/General | Posted 14/09/2018
Novartis accused of pay-for-delay, while Amgen... Generics/General | Posted 14/09/2018
Comparison of biosimilar and originator bevaciz... Biosimilars/Research | Posted 14/09/2018
AbbVie ruled to pay nearly US$450 million for a... Policies & Legislation | Posted 14/09/2018
Australia approves first capsule-form Viagra ge... Generics/News | Posted 14/09/2018
FDA guidance sought on false and misleading inf... Biosimilars/General | Posted 07/09/2018
Trastuzumab and Bevacizumab products approved i... Biosimilars/News | Posted 07/09/2018
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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...

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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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