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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...

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Comments on extrapolation in FDA’s interchangea... Guidelines | Posted 16/06/2017
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
Big Pharma comments on FDA’s interchangeability... Guidelines | Posted 09/06/2017
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
Interchangeability of biosimilars in the US Reports | 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
German drugmaker Stada to be sold for over US$5... Pharma News | Posted 02/06/2017
Interchangeability of biosimilars around the world Reports | 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
Japan’s Sawai to acquire US generics business U... Pharma 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
EMA biosimilars guidance for healthcare profess... Guidelines | 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
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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...

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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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