Health Canada approves Inflectra biosimilar for extra indications

Posted 24/06/2016

US-based generics maker Hospira, now part of Pfizer, announced on 14 June 2016 that its infliximab biosimilar Inflectra had received approval from Canada’s m...

Reasons for the success of a generics company i... Generics/Research | Posted 24/06/2016
Biosimilar rituximab in biological naïve rheuma... Biosimilars/Research | Posted 24/06/2016
Insulin biosimilar meets primary endpoint in ph... Biosimilars/Research | Posted 24/06/2016
Glenmark gains approval for anti-epileptic generic Generics/News | Posted 24/06/2016
AMRI acquires API maker Euticals Pharma News | Posted 24/06/2016
World Biosimilar Congress Europe 2016 Conferences | Posted 24/06/2016
Improvement in uptake of biosimilars in Spain Biosimilars/Research | Posted 17/06/2016
Immunogenicity of biologicals: the role of post... Biosimilars/Research | Posted 17/06/2016
Pharmacists prefer generic OTC medicines Generics/Research | Posted 17/06/2016
GPhA raises concerns over CMS biosimilars reimb... Policies & Legislation | Posted 17/06/2016
China cuts prices for three drugs by more than 50% Generics/General | Posted 17/06/2016
Dr Reddy’s to buy US generics from Teva Generics/News | Posted 17/06/2016
Alvogen opening biosimilars plant in Iceland Biosimilars/News | Posted 17/06/2016
Effectiveness of ESAs in treating anaemia in ki... Biosimilars/Research | Posted 10/06/2016
The Netherlands to track switching of biologicals Policies & Legislation | Posted 10/06/2016
Biosimilars of eculizumab Biosimilars/General | Posted 10/06/2016
Switching between generics of anti-epileptic drugs Generics/Research | Posted 10/06/2016
Rituximab biosimilar from Sandoz accepted for r... Biosimilars/News | Posted 10/06/2016
Samsung Bioepis infliximab biosimilar accepted... Biosimilars/News | Posted 03/06/2016
Monoclonal antibodies and the challenge of subs... Biosimilars/Research | Posted 03/06/2016
Colombia fighting to break Glivec monopoly Policies & Legislation | Posted 03/06/2016
Roche sues India’s drug regulator over Avastin... Biosimilars/General | Posted 03/06/2016
Dr Reddy’s buys six OTC brands from Ducere Pharma Generics/News | Posted 03/06/2016
Pharmacokinetic behaviour of a trastuzumab bioc... Biosimilars/Research | Posted 03/06/2016
Switching between different ESAs Biosimilars/Research | Posted 27/05/2016
Cost-effectiveness analysis and incentivizing i... Generics/Research | Posted 27/05/2016
Industry calls for generics user fees to be red... Policies & Legislation | Posted 27/05/2016
Positive phase III results for omalizumab copy... Biosimilars/News | Posted 27/05/2016
GSK appeals UK pay-for-delay fine Generics/News | Posted 27/05/2016
Uptake of biosimilars increasing in Spain Biosimilars/Research | Posted 20/05/2016
Clinical and regulatory issues for biosimilars Biosimilars/Research | Posted 20/05/2016
Samsung Bioepis to launch infliximab biosimilar... Biosimilars/News | Posted 20/05/2016
Perceptions of the value of generics in Brazil Generics/Research | Posted 20/05/2016
Japan proving to be a favourable market for bio... Biosimilars/General | Posted 20/05/2016
Australian generics maker opens clinical trials... Generics/General | Posted 20/05/2016
Approaches to increase uptake of biosimilars in... Biosimilars/Research | Posted 13/05/2016
Benepali wins Danish tender for etanercept Biosimilars/General | Posted 13/05/2016
Perceptions of the substitution of generics Generics/Research | Posted 13/05/2016


US guidelines for follow-on NBCDs Posted 10/06/2016

The regulatory body for approval of medicines in the US is the Food and Drug...


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