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Recommendations for the use of biosimilars in rheumatic diseases

 Posted 13/10/2017

Biological therapies have become a central part of the long-term management of many chronic diseases, including inflammatory rheumatic diseases.

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EMA accepts application for pegfilgrastim biosi... Biosimilars/News | Posted 13/10/2017
Adalimumab biosimilar ABP 501 shows similar eff... Biosimilars/Research | Posted 13/10/2017
Nichi-Iko gains Japanese approval for inflixima... Biosimilars/News | Posted 13/10/2017
Barriers to access to biosimilars Biosimilars/Research | Posted 13/10/2017
Challenges in the rediscovery of old generics Generics/Research | Posted 13/10/2017
Synthon prevails over Copaxone patent dispute Pharma News | Posted 13/10/2017
FDA approves lidocaine ointment generic from Vi... Generics/News | Posted 13/10/2017
Repurposing thioguanine Generics/Research | Posted 06/10/2017
JCR files for Japanese approval of agalsidase b... Biosimilars/News | Posted 06/10/2017
Amgen and Simcere to collaborate on copy biolog... Pharma News | Posted 06/10/2017
Integrating biosimilars into clinical practice Biosimilars/Research | Posted 06/10/2017
FDA accepts application for Adello’s filgrastim... Biosimilars/News | Posted 06/10/2017
FDA Commissioner discusses challenges and oppor... Biosimilars/General | Posted 06/10/2017
US tribal patent deal could prevent generics Generics/General | Posted 06/10/2017
Application fees increase for prescription drugs Policies & Legislation | Posted 06/10/2017
FDA issues draft guidance on statistical approa... Guidelines | Posted 29/09/2017
EMA approval for adalimumab and trastuzumab bio... Biosimilars/News | Posted 29/09/2017
Biosimilars for rheumatic diseases Biosimilars/Research | Posted 29/09/2017
FDA accepts application for rituximab biosimila... Biosimilars/News | Posted 29/09/2017
Repurposing and re-registering old generics Generics/Research | Posted 29/09/2017
Equivalence of rituximab biosimilar in rheumato... Biosimilars/Research | Posted 29/09/2017
Competition lacking in the Mexican drug market Reports | Posted 29/09/2017
Biocon withdraws EU applications for trastuzuma... Biosimilars/General | Posted 29/09/2017
Medicines for Europe 17th Regulatory and Scient... Conferences | Posted 29/09/2017
FDA approves bevacizumab biosimilar Mvasi Biosimilars/News | Posted 22/09/2017
Positive phase III results for Pfizer’s trastuz... Biosimilars/Research | Posted 22/09/2017
Regulatory pathways for approval of biological... Reports | Posted 22/09/2017
Comparable efficacy and safety observed in pati... Biosimilars/Research | Posted 22/09/2017
Second etanercept biosimilar approved in Canada Biosimilars/News | Posted 22/09/2017
FDA forms working group to increase generics co... Generics/General | Posted 22/09/2017
Biosimilars applications under review by EMA –... Biosimilars/General | Posted 22/09/2017
Indivior to appeal US ruling on opioid addictio... Generics/News | Posted 22/09/2017
WHO launches consultation on prequalification o... Biosimilars/General | Posted 15/09/2017
Sanofi receives tentative FDA approval for insu... Biosimilars/News | Posted 15/09/2017
Positive phase III results for Amgen’s trastuzu... Biosimilars/Research | Posted 15/09/2017
Fresenius Kabi acquires Merck KGaA’s biosimilar... Pharma News | Posted 15/09/2017
Positive phase I results for rituximab biosimil... Biosimilars/Research | Posted 15/09/2017
Generics applications under review by EMA – Aug... Generics/General | Posted 15/09/2017
Two trastuzumab biosimilars submitted to FDA Biosimilars/News | Posted 15/09/2017
Mylan launches three HIV generics in Canada Generics/News | Posted 15/09/2017
Strategies of players on the global biopharmace... Biosimilars/Research | Posted 08/09/2017
EC approval for three rituximab biosimilars Biosimilars/News | Posted 08/09/2017
Ireland consults on National Biosimilar Medicin... Policies & Legislation | Posted 08/09/2017
Boehringer Ingelheim starts phase III interchan... Biosimilars/News | Posted 08/09/2017
Regulation of follow-on biological products in... Reports | Posted 08/09/2017
Biological drug evolution: improved awareness a... Biosimilars/Research | Posted 08/09/2017
New EMA reflection paper on setting dissolution... Guidelines | Posted 08/09/2017
Teva launches generic testosterone Generics/News | Posted 08/09/2017
DIA Biosimilars Conference 2017 Conferences | Posted 08/09/2017
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NON-BIOLOGICAL COMPLEX DRUGS

FDA approves follow-on version of sevelamer Posted 30/06/2017

Indian generics maker Aurobindo Pharma (Aurobindo) announced on 15 June 2017...

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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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