EMA approval for insulin and rituximab biosimilars

Posted 26/05/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 May 2017 that it had recommended granting marketi...

more
Biosimilar substitution in Europe Reports | Posted 26/05/2017
Lawmakers urge CMS to reverse its biosimilars p... Policies & Legislation | Posted 26/05/2017
Generic substitution of antiretroviral drugs in... Generics/Research | Posted 26/05/2017
Biosimilars in the treatment of inflammatory bo... Biosimilars/Research | Posted 26/05/2017
Vytorin generic launched in the US Generics/News | Posted 26/05/2017
EMA guidance for NBCDs and products approved Biosimilars/Research | Posted 26/05/2017
Generics and biosimilars: status in the EU Generics/General | Posted 26/05/2017
Danish infliximab switching study shows no diff... Biosimilars/Research | Posted 19/05/2017
Post-marketing experience with IBD biosimilars Biosimilars/Research | Posted 19/05/2017
Biosimilars applications under review by EMA –... Biosimilars/General | Posted 19/05/2017
Concerns over change to generics prescribing in... Generics/General | Posted 19/05/2017
Product-specific pharmacovigilance Reports | Posted 19/05/2017
Positive phase I results for Cinfa’s pegfilgras... Biosimilars/News | Posted 19/05/2017
Apotex petitions FDA over Neulasta biosimilars Guidelines | Posted 19/05/2017
WHO to launch prequalification programme for bi... Biosimilars/General | Posted 12/05/2017
Accountability, safety and competition in biolo... Biosimilars/Research | Posted 12/05/2017
Second infliximab biosimilar to be launched in... Biosimilars/News | Posted 12/05/2017
Generics applications under review by EMA – Apr... Generics/General | Posted 12/05/2017
Sound pharmacy practices for biosimilars Reports | Posted 12/05/2017
US introduces two new bills to promote generics Policies & Legislation | Posted 12/05/2017
Safe switching for biosimilars Reports | Posted 05/05/2017
Computer modelling for glycoengineering of bios... Biosimilars/Research | Posted 05/05/2017
FDA approves biosimilar infliximab Renflexis Biosimilars/News | Posted 05/05/2017
Reference pricing for generics in Switzerland Generics/Research | Posted 05/05/2017
How will the timing of BPCI Act 180-day notice... Policies & Legislation | Posted 05/05/2017
First Advair generic launched in the US Generics/News | Posted 05/05/2017
Approaches to assure quality and improve patien... Generics/Research | Posted 28/04/2017
EMA approval for etanercept and rituximab biosi... Biosimilars/News | Posted 28/04/2017
Prospective study finds switching to biosimilar... Biosimilars/Research | Posted 28/04/2017
Fujifilm ramps up biosimilars production as UK... Biosimilars/General | Posted 28/04/2017
Patent challenges hit Actavis and Acorda Generics/News | Posted 28/04/2017
Biosimilarity is not interchangeability Reports | Posted 21/04/2017
Rituximab biosimilar safe in advanced follicula... Biosimilars/Research | Posted 21/04/2017
Advances in ranibizumab and teriparatide biosim... Biosimilars/News | Posted 21/04/2017
Significant price reductions possible for new c... Generics/Research | Posted 21/04/2017
Biosimilars of certolizumab pegol Biosimilars/General | Posted 21/04/2017
Maryland has increased power over drug prices Policies & Legislation | Posted 21/04/2017
Harmonization of requirements for NBCDs across... Biosimilars/Research | Posted 21/04/2017
Indian drug industry faces setbacks in Europe a... Generics/General | Posted 21/04/2017
US pharmacists’ views on the naming and labelli... Biosimilars/Research | Posted 14/04/2017
Trastuzumab biosimilar submitted for approval i... Biosimilars/News | Posted 14/04/2017
Italian study compares epoetin biosimilars and... Biosimilars/Research | Posted 14/04/2017
Generics could cut costs of cancer drugs by ove... Generics/Research | Posted 14/04/2017
more

NON-BIOLOGICAL COMPLEX DRUGS

Challenges in the regulation of NBCDs Posted 12/05/2017

Author Leonie Hussaarts and colleagues discuss in a white paper the regulator...

more


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
more

Generics News Research General

more

Biosimilars News Research General

more