Do patent strategies delay market entry of biosimilar monoclonal antibodies in Europe?

Posted 22/05/2020

Patents have been shown to be the main determinant to guarantee market exclusivity of originator biologicals [1], with patent disputes causing uncertainty on...

Canada approves rituximab biosimilars Riximyo a... Biosimilars/News | Posted 22/05/2020
Reimbursement of biosimilars in the US Biosimilars/General | Posted 22/05/2020
Amgen on both sides of the biosimilar arena Biosimilars/General | Posted 22/05/2020
Impact of upcoming regulatory changes on patent... Policies & Legislation | Posted 22/05/2020
EMA recommends approval of Sanofi’s insulin asp... Biosimilars/News | Posted 15/05/2020
Scientific evidence in development of trastuzum... Biosimilars/Research | Posted 15/05/2020
Biosimilar education gaps in oncology Biosimilars/Research | Posted 15/05/2020
US FDA clears Biocon manufacturing sites in Mal... Biosimilars/General | Posted 15/05/2020
Australia’s regulatory body proposes transparen... Policies & Legislation | Posted 15/05/2020
Why does the US face high-priced generics and d... Generics/Research | Posted 15/05/2020
Pegfilgrastim biosimilar Fulphila launched in C... Biosimilars/News | Posted 08/05/2020
How to make biological drugs more affordable Biosimilars/Research | Posted 08/05/2020
Mycenax sells tocilizumab biosimilar to Richter Pharma News | Posted 08/05/2020
COVID-19 brings new collaborations to Australia... Policies & Legislation | Posted 08/05/2020
Online education for diabetes specialists on bi... Biosimilars/General | Posted 08/05/2020
Celltrion files application with EMA for adalim... Biosimilars/News | Posted 08/05/2020
FDA approves Proventil and Daraprim generics Generics/News | Posted 08/05/2020
Non-innovator biologicals in India: regulatory... Biosimilars/Research | Posted 04/05/2020
Biocon/Mylan launch pegfilgrastim biosimilar Fu... Biosimilars/News | Posted 04/05/2020
Five key questions about the ‘patent dance’ ans... Policies & Legislation | Posted 04/05/2020
New information on biosimilars from Australia a... Biosimilars/General | Posted 04/05/2020
Clinical trials for adalimumab biosimilar SB5 Biosimilars/Research | Posted 04/05/2020
CMS proposes new measures to rate generic usage Generics/General | Posted 04/05/2020
Merck launches trastuzumab biosimilar in the US Biosimilars/News | Posted 24/04/2020
Assessment of biosimilarity for monoclonal anti... Biosimilars/Research | Posted 24/04/2020
Alberta delays deadline for forced medication s... Policies & Legislation | Posted 24/04/2020
FDA releases new information on interchangeable... Biosimilars/General | Posted 24/04/2020
EC approval for rituximab biosimilar Ruxience Biosimilars/News | Posted 24/04/2020
Science, outreach, development: US Generics Dru... Generics/General | Posted 24/04/2020
Amgevita approved in Colombia Biosimilars/News | Posted 17/04/2020
Biosimilars highlights: 2019 Biosimilars/General | Posted 17/04/2020
Mabion withdraws application for rituximab bios... Biosimilars/News | Posted 17/04/2020
British Columbia releases latest data on biosim... Biosimilars/General | Posted 17/04/2020
CMS launches insulin co-pay at US$35 Policies & Legislation | Posted 17/04/2020
Clinical trials for adalimumab biosimilar BI 69... Biosimilars/Research | Posted 17/04/2020
Comparison of economic loss between generics an... Generics/Research | Posted 17/04/2020
Improving the pathway for generics approval in... Generics/General | Posted 17/04/2020
Guidelines released on USAN naming Guidelines | Posted 10/04/2020
Clinical trials for adalimumab biosimilar ABP 501 Biosimilars/Research | Posted 10/04/2020


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