SUBSCRIBE

FDA approval for Amgen’s infliximab biosimilar Avsola

 Posted 13/12/2019

US-based biotech giant Amgen announced on 6 December 2019 that it had received approval from the US Food and Drug Administration (FDA) for its inflixima...

more
Canadian gastroenterologists issue biosimilar p... Biosimilars/General | Posted 13/12/2019
Bio-Thera gains Chinese approval for adalimumab... Biosimilars/News | Posted 13/12/2019
Bill to stop misuse of Citizen Petitions advanc... Policies & Legislation | Posted 13/12/2019
The impact of generics regulation in Brazil Generics/Research | Posted 13/12/2019
Pharmacists must be ready to take the lead on b... Biosimilars/Research | Posted 13/12/2019
Ontario proposes regulatory changes to simplify... Generics/General | Posted 13/12/2019
FDA issues updated guidance on implementing GDU... Guidelines | Posted 13/12/2019
Australia approves five biosimilars since June... Biosimilars/News | Posted 06/12/2019
Health Canada publishes biosimilars fact sheet Guidelines | Posted 06/12/2019
How to support a viable US biosimilars market Reports | Posted 06/12/2019
Use of pegfilgrastim copy biological Mecapegfil... Biosimilars/Research | Posted 06/12/2019
WHO prequalifies antiparasitic API Generics/General | Posted 06/12/2019
Phase III trials started for bevacizumab and na... Biosimilars/News | Posted 06/12/2019
Samsung Bioepis expands biosimilars agreement w... Pharma News | Posted 06/12/2019
EMA recommends approval for two new generics Generics/News | Posted 06/12/2019
FDA issues draft guidance for insulin biosimilars Guidelines | Posted 29/11/2019
EC approval for subcutaneous infliximab biosimi... Biosimilars/News | Posted 29/11/2019
WHO launches insulin prequalification programme Biosimilars/General | Posted 29/11/2019
Biosimilar education for Canadian nurses Biosimilars/Research | Posted 29/11/2019
16704526_l
Lupin to launch etanercept and pegfilgrastim b... Biosimilars/News | Posted 29/11/2019
The sluggish US biosimilars market Reports | Posted 29/11/2019
FDA generics approvals increasing but not for a... Generics/Research | Posted 29/11/2019
Alvotech signs agreements with Stada and Yas Ho... Pharma News | Posted 29/11/2019
Switching V19A17
Concerns raised as Canada’s Alberta plans to sw... Policies & Legislation | Posted 22/11/2019
FDA approves adalimumab biosimilar Abrilada Biosimilars/News | Posted 22/11/2019
Varied approach to interchangeability across th... Reports | Posted 22/11/2019
Qilu starts phase III trial for denosumab copy... Biosimilars/News | Posted 22/11/2019
Brazilian efficacy and safety data for biosimil... Biosimilars/Research | Posted 22/11/2019
Lupin to sell its Japanese arm and Sandoz to ac... Pharma News | Posted 22/11/2019
FDA identifies causes of drug shortages, recomm... Generics/General | Posted 22/11/2019
Dubai’s LIFEPharma signs historic agreement wit... Generics/News | Posted 22/11/2019
Biologicals and biosimilar use in Asian patient... Biosimilars/Research | Posted 15/11/2019
Adalimumab copy biological accepted for review... Biosimilars/News | Posted 15/11/2019
Oncology pharmacists issue position statement o... Biosimilars/General | Posted 15/11/2019
Phase I trials started for aflibercept and uste... Biosimilars/News | Posted 15/11/2019
Designing fit-for-purpose biosimilar studies Reports | Posted 15/11/2019
Samsung reveals positive trial results for beva... Biosimilars/Research | Posted 15/11/2019
Safety of generics in US questioned Generics/Research | Posted 15/11/2019
Alvogen gains exclusive rights to market parath... Pharma News | Posted 15/11/2019
Medicines for Europe 18th Biosimilar Medicines... Conferences | Posted 15/11/2019
Terrapinn Festival of Biologics USA 2020 Conferences | Posted 15/11/2019
Medicines for Europe 16th Legal Affairs Confere... Conferences | Posted 15/11/2019
Uptake of biosimilars in different countries va... Reports | Posted 08/11/2019
22119008_l
FDA approves pegfilgrastim biosimilar Ziextenzo Biosimilars/News | Posted 04/11/2019
EC publishes biosimilar information for healthc... Guidelines | Posted 08/11/2019
Biosimilar regulation in the Middle East Reports | Posted 08/11/2019
Clinical data requirements for biosimilars in t... Biosimilars/Research | Posted 08/11/2019
Generics transition brings economic benefits to... Generics/Research | Posted 08/11/2019
Tanvex BioPharma’s filgrastim biosimilar comes... Biosimilars/News | Posted 08/11/2019
more

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...

more


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
more

Country Focus

All countries

Sign up today to receive weekly news on the latest developments in generic and biosimilar medicines!

Generics News Research General

more

Biosimilars News Research General

more

More editorial sections