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...

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


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...


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