Notice can be given before FDA approves biosimilar

Posted 16/06/2017

In a landmark decision by the US Supreme Court, biosimilars makers will be able to give notice to the originator manufacturer before the US Food and Drug Adm...

Biosimilar infliximab safe and effective in IBD Biosimilars/Research | Posted 16/06/2017
Recommendations to enhance transparency of bios... Biosimilars/General | Posted 16/06/2017
FDA advisors recommend approval of Pfizer’s epo... Biosimilars/News | Posted 16/06/2017
FDA targets rising drug prices by increasing ge... Generics/General | Posted 16/06/2017
Celltrion making progress with biosimilars in C... Biosimilars/News | Posted 16/06/2017
FDA approves two new Seroquel XR generics Generics/News | Posted 16/06/2017
FDA advisory committee to review bevacizumab an... Biosimilars/News | Posted 09/06/2017
Oncology drug pricing – the case of generic ima... Generics/Research | Posted 09/06/2017
Infliximab biosimilar coming closer to intercha... Biosimilars/Research | Posted 09/06/2017
Japan plans to increase generics use Generics/General | Posted 09/06/2017
Predictive modelling of CIN prophylaxis with bi... Biosimilars/Research | Posted 09/06/2017
Generics association recommends FDA regulation... Policies & Legislation | Posted 09/06/2017
Exl events Biosimilar Market Access and Commerc... Conferences | Posted 09/06/2017
Comments on FDA’s interchangeability guidance Guidelines | Posted 02/06/2017
EMA accepts application for adalimumab biosimil... Biosimilars/News | Posted 02/06/2017
How the FDA regulates biosimilars Biosimilars/Research | Posted 02/06/2017
Generic substitution of antiretroviral drugs in... Generics/Research | Posted 02/06/2017
Positive phase III results for Sandoz’s adalimu... Biosimilars/Research | Posted 02/06/2017
Call to phase out branded drugs in India Generics/General | Posted 02/06/2017
SMi Biosimilars and Biobetters 2017 Conferences | Posted 02/06/2017
SMi 4th Annual Biosimilars North America Conferences | Posted 02/06/2017
EMA approval for insulin and rituximab biosimilars Biosimilars/News | Posted 26/05/2017
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


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

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


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