SUBSCRIBE

FDA approves bevacizumab biosimilar Mvasi

 Posted 22/09/2017

On 14 September 2017, the US Food and Drug Administration (FDA) approved its first biosimilar for the treatment of cancer.

more
Positive phase III results for Pfizer’s trastuz... Biosimilars/Research | Posted 22/09/2017
Regulatory pathways for approval of biological... Reports | Posted 22/09/2017
Comparable efficacy and safety observed in pati... Biosimilars/Research | Posted 22/09/2017
Second etanercept biosimilar approved in Canada Biosimilars/News | Posted 22/09/2017
FDA forms working group to increase generics co... Generics/General | Posted 22/09/2017
Biosimilars applications under review by EMA –... Biosimilars/General | Posted 22/09/2017
Indivior to appeal US ruling on opioid addictio... Generics/News | Posted 22/09/2017
WHO launches consultation on prequalification o... Biosimilars/General | Posted 15/09/2017
Sanofi receives tentative FDA approval for insu... Biosimilars/News | Posted 15/09/2017
Positive phase III results for Amgen’s trastuzu... Biosimilars/Research | Posted 15/09/2017
Fresenius Kabi acquires Merck KGaA’s biosimilar... Pharma News | Posted 15/09/2017
Positive phase I results for rituximab biosimil... Biosimilars/Research | Posted 15/09/2017
Generics applications under review by EMA – Aug... Generics/General | Posted 15/09/2017
Two trastuzumab biosimilars submitted to FDA Biosimilars/News | Posted 15/09/2017
Mylan launches three HIV generics in Canada Generics/News | Posted 15/09/2017
Strategies of players on the global biopharmace... Biosimilars/Research | Posted 08/09/2017
EC approval for three rituximab biosimilars Biosimilars/News | Posted 08/09/2017
Ireland consults on National Biosimilar Medicin... Policies & Legislation | Posted 08/09/2017
Boehringer Ingelheim starts phase III interchan... Biosimilars/News | Posted 08/09/2017
Regulation of follow-on biological products in... Reports | Posted 08/09/2017
Biological drug evolution: improved awareness a... Biosimilars/Research | Posted 08/09/2017
New EMA reflection paper on setting dissolution... Guidelines | Posted 08/09/2017
Teva launches generic testosterone Generics/News | Posted 08/09/2017
DIA Biosimilars Conference 2017 Conferences | Posted 08/09/2017
FDA approves adalimumab biosimilar Cyltezo Biosimilars/News | Posted 01/09/2017
Australia’s TGA consults on naming of biologicals Biosimilars/General | Posted 01/09/2017
Rituximab biosimilar CT-P10 could save Europe E... Biosimilars/Research | Posted 01/09/2017
Producing follow-on biological products in Brazil Reports | Posted 01/09/2017
Barriers to generics substitution in the Middle... Generics/Research | Posted 01/09/2017
Biological drug evolution: inadequate short-ter... Biosimilars/Research | Posted 01/09/2017
EC approval for adalimumab biosimilar Imraldi Biosimilars/News | Posted 01/09/2017
FDA receives record number of generic drug appl... Generics/General | Posted 01/09/2017
Barriers to the market access of biosimilar mon... Biosimilars/Research | Posted 25/08/2017
New FDA guidance on biological manufacturing ch... Guidelines | Posted 25/08/2017
Generic drug substitution in Lebanon Generics/Research | Posted 25/08/2017
Building trust in biosimilars Reports | Posted 25/08/2017
Adello Biologics starts phase I trial for pegfi... Biosimilars/Research | Posted 25/08/2017
Senior US senator calls on insulin manufacturer... Generics/General | Posted 25/08/2017
Adamis gains FDA approval for its EpiPen rival Generics/News | Posted 25/08/2017
FDA looks set to break record for generic drug... Reports | Posted 25/08/2017
Medicines for Europe 11th Pharmacovigilance Con... Conferences | Posted 25/08/2017
Terrapinn World Biosimilar Congress 2017 Conferences | Posted 25/08/2017
WHO prequalifies first generic hepatitis C drug Generics/General | Posted 18/08/2017
Biosimilar pegfilgrastim highly similar to Neul... Biosimilars/Research | Posted 18/08/2017
Biosimilars of insulin lispro Biosimilars/General | Posted 18/08/2017
Real-life data supports efficacy and safety of... Biosimilars/Research | Posted 18/08/2017
Biocad’s rituximab ‘similar biologic’ recommend... Biosimilars/News | Posted 18/08/2017
FDA to speed up review of priority generics Guidelines | Posted 18/08/2017
Generics in Greece most expensive in the EU and... Pharma News | Posted 18/08/2017
more

NON-BIOLOGICAL COMPLEX DRUGS

FDA approves follow-on version of sevelamer Posted 30/06/2017

Indian generics maker Aurobindo Pharma (Aurobindo) announced on 15 June 2017...

more


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