Mylan launches first trastuzumab biosimilar in Australia

Posted 23/08/2019

Global generics firm Mylan NV (Mylan) and collaborating Indian pharmaceuticals giant Biocon Ltd (Biocon) have announced the launch of the first trastuzumab b...

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Samsung Bioepis starts phase III trial for ecul... Biosimilars/News | Posted 23/08/2019
Australia approves three biosimilars in first h... Biosimilars/General | Posted 23/08/2019
China audits drug companies Policies & Legislation | Posted 23/08/2019
Generic irbesartan is safe and effective, shows... Generics/Research | Posted 23/08/2019
Safety of SC form of infliximab biosimilar CT-P13 Biosimilars/Research | Posted 23/08/2019
FDA approves Farxiga generic Generics/News | Posted 23/08/2019
FDA approves adalimumab biosimilar Hadlima Biosimilars/News | Posted 16/08/2019
Korean firms to launch biosimilars in Japan des... Biosimilars/News | Posted 16/08/2019
Biosimilars applications under review by EMA –... Biosimilars/General | Posted 16/08/2019
Positive phase III results for bevacizumab copy... Biosimilars/Research | Posted 16/08/2019
Prices for infectious disease treatments and ho... Generics/Research | Posted 16/08/2019
IPRP expands and all EU Member States now inclu... Policies & Legislation | Posted 16/08/2019
Extensive characterization of biosimilars: a pe... Biosimilars/Research | Posted 16/08/2019
Distinct suffixes will aid biosimilar competiti... Biosimilars/Research | Posted 09/08/2019
EMA accepts first application for Chinese-made... Biosimilars/News | Posted 09/08/2019
Bill introduced in US to cut insulin prices Policies & Legislation | Posted 09/08/2019
South Korea’s Celltrion to sell directly to Aus... Biosimilars/General | Posted 09/08/2019
Rituximab copy biological accepted for review i... Biosimilars/News | Posted 09/08/2019
Real-world data on switching of etanercept bios... Biosimilars/Research | Posted 09/08/2019
Certara technology achieves first FDA virtual... Generics/News | Posted 09/08/2019
FDA approves rituximab biosimilar Ruxience Generics/News | Posted 02/08/2019
Long-term safety results for adalimumab biosimilar Biosimilars/Research | Posted 02/08/2019
Positive phase III data for adalimumab copy bio... Biosimilars/Research | Posted 02/08/2019
Bipartisan bill aims to reduce healthcare costs... Policies & Legislation | Posted 02/08/2019
Lannett starts phase I trial for insulin glargi... Biosimilars/News | Posted 02/08/2019
Generics applications under review by EMA – Jul... Generics/General | Posted 02/08/2019
NHS England updates its ‘What is a Biosimilar M... Biosimilars/General | Posted 02/08/2019
EMA accepts application for bevacizumab biosimi... Biosimilars/News | Posted 26/07/2019
Positive results for rituximab non-originator a... Biosimilars/Research | Posted 26/07/2019
US FDA acts to improve transparency and predict... Policies & Legislation | Posted 26/07/2019
Positive phase III results for trastuzumab bios... Biosimilars/Research | Posted 26/07/2019
South Korea increases investment in biologicals Biosimilars/General | Posted 26/07/2019
Sandoz to start phase III trial for denosumab b... Biosimilars/News | Posted 26/07/2019
Generic Drug User Fee Act is a benefit to the I... Generics/Research | Posted 26/07/2019
FDA approves bevacizumab biosimilar Zirabev Biosimilars/News | Posted 19/07/2019
Real-world data confirms safety of infliximab b... Biosimilars/Research | Posted 19/07/2019
Asian specialists recommendations for off-paten... Biosimilars/Research | Posted 19/07/2019
Positive phase III results for trastuzumab foll... Biosimilars/Research | Posted 19/07/2019
Gilead’s Truvada will face generics competition... Generics/General | Posted 19/07/2019
EMA approves two generics for fungal infections Generics/News | Posted 19/07/2019
AAM GRx+Biosims 2019 Conferences | Posted 19/07/2019
Medicines for Europe 3rd Value Added Medicines... Conferences | Posted 19/07/2019
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NON-BIOLOGICAL COMPLEX DRUGS

FDA issues final guidance on liposome drug products Posted 27/04/2018

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft...

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FDA approves 40 mg follow-on version of glatira... Non‐Biological Complex Drugs/News | Posted 09/03/2018
Mylan launches first follow-on glatiramer aceta... Non‐Biological Complex Drugs/News | Posted 15/02/2018
Biosimilars and follow-on NBCDs for MS in Europ... Non‐Biological Complex Drugs/Research | Posted 19/01/2018
Impax announces FDA approval of follow-on sevel... Non‐Biological Complex Drugs/News | Posted 17/11/2017
FDA approves follow-on version of sevelamer Non‐Biological Complex Drugs/News | Posted 30/06/2017
Challenges in the regulation of NBCDs Non‐Biological Complex Drugs/Research | Posted 12/05/2017
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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