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...

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


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