Pharma associations issue position paper on biosimilar switching

Posted 17/03/2017

The European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE) and the International Federation...

more
Improving efficacy of biologicals without incre... Biosimilars/Research | Posted 17/03/2017
Global settlement clears a pathway for trastuzu... Biosimilars/News | Posted 17/03/2017
Revised Q&As on biosimilars for patients Reports | Posted 17/03/2017
Savings to be made by using etanercept biosimil... Biosimilars/Research | Posted 17/03/2017
Delaying generics using citizen petitions Generics/Research | Posted 17/03/2017
FDA approves rare disease deflazacort at exorbi... Generics/News | Posted 17/03/2017
FDA updates purple book for biologicals and bio... Biosimilars/General | Posted 10/03/2017
Russian approval for non-originator interferon... Biosimilars/News | Posted 10/03/2017
Positive results for infliximab biosimilar in C... Biosimilars/Research | Posted 10/03/2017
Promoting and regulating generics in Brazil Generics/Research | Posted 10/03/2017
Ireland to publish biosimilars report Policies & Legislation | Posted 10/03/2017
Generic lung cancer treatment now available in... Generics/News | Posted 10/03/2017
AAM 2017 CMC Workshop Conferences | Posted 10/03/2017
Leading on Biosimilars: The 2017 AAM Biosimilar... Conferences | Posted 10/03/2017
Rising costs of cancer treatments not matched b... Generics/Research | Posted 03/03/2017
EC approval for first cancer biosimilar Truxima Biosimilars/News | Posted 03/03/2017
Biosimilars of teriparatide Biosimilars/General | Posted 03/03/2017
British oncologists back biosimilar mAbs to tre... Policies & Legislation | Posted 03/03/2017
Candidate trastuzumab biosimilar meets equivale... Biosimilars/Research | Posted 03/03/2017
Malaysian Government approves new generics faci... Generics/General | Posted 03/03/2017
Safe for IBD patients to switch to biosimilar i... Biosimilars/Research | Posted 24/02/2017
FDA accepts application for Mylan/Biocon’s pegf... Biosimilars/News | Posted 24/02/2017
World Trade Organization allows generics import... Policies & Legislation | Posted 24/02/2017
Biocon wins three-year contract to supply insul... Biosimilars/News | Posted 24/02/2017
US approves generic of narcolepsy drug Xyrem Generics/News | Posted 24/02/2017
Etanercept biosimilar submitted for approval in... Biosimilars/News | Posted 17/02/2017
Regional management of biosimilars in Germany Biosimilars/Research | Posted 17/02/2017
Generics and brand-name drugs compared Generics/Research | Posted 17/02/2017
Positive results for Pfizer’s adalimumab biosim... Biosimilars/Research | Posted 17/02/2017
Novo Nordisk becomes second pharma company to c... Generics/General | Posted 17/02/2017
Joint 23rd Medicines for Europe and 20th IGBA A... Conferences | Posted 17/02/2017
Biosimilars in 2016: the highlights Biosimilars/General | Posted 10/02/2017
EMA approval for adalimumab biosimilars Amgevit... Biosimilars/News | Posted 10/02/2017
Switching stable kidney transplant patients to... Generics/Research | Posted 10/02/2017
Positive phase III results for adalimumab biosi... Biosimilars/Research | Posted 10/02/2017
New FDA guidance to speed up generics approvals Guidelines | Posted 10/02/2017
Position statement on approval of biosimilars i... Biosimilars/Research | Posted 10/02/2017
Sandoz withdraws biosimilar pegfilgrastim appli... Biosimilars/News | Posted 03/02/2017
US Supreme Court to review 180-day notice for b... Policies & Legislation | Posted 03/02/2017
more

NON-BIOLOGICAL COMPLEX DRUGS

Warning letter causes delays for follow-on glatiramer acetate Posted 17/03/2017

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 17...

more


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
more

Generics News Research General

more

Biosimilars News Research General

more