How do the biosimilar markets in the US and Europe compare?
Posted 19/02/2021Authors discuss how the biosimilar markets in the US and Europe compare in a report produced for the Biosimilars Council [1].
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Canada approves infliximab biosimilar Remsima SC
Biosimilars/News |
Posted 19/02/2021
Improving stakeholder understanding about biosi...
Biosimilars/Research |
Posted 19/02/2021
Innovent starts phase II trial for ipilimumab c...
Biosimilars/News |
Posted 19/02/2021
UK’s MHRA publishes guidance on licensing biosi...
Guidelines |
Posted 19/02/2021
Adherence improves long-term prognosis and medi...
Generics/Research |
Posted 19/02/2021
Biosimilar approvals and patent litigation in t...
Biosimilars/General |
Posted 19/02/2021
Problems with the tiered pricing policy for gen...
Policies & Legislation |
Posted 19/02/2021
Interchangeability, naming and pharmacovigilanc...
Biosimilars/Research |
Posted 12/02/2021
EMA recommends approval of adalimumab biosimila...
Biosimilars/News |
Posted 12/02/2021
What can the US learn from the European biosimi...
Reports |
Posted 12/02/2021
Innovent makes deal for bevacizumab copy biolog...
Pharma News |
Posted 12/02/2021
Improving the understanding of biosimilars thro...
Biosimilars/Research |
Posted 12/02/2021
Anti-competitive strategic patenting by pharmac...
Generics/Research |
Posted 12/02/2021
FDA publishes report on areas of regulatory foc...
Reports |
Posted 12/02/2021
Canada approves insulin aspart biosimilar Trurapi
Biosimilars/News |
Posted 12/02/2021
Regulatory issues related to quality of biosimi...
Biosimilars/Research |
Posted 05/02/2021
FDA includes generics of complex drugs in regul...
Reports |
Posted 05/02/2021
China extends indications for adalimumab and be...
Biosimilars/News |
Posted 05/02/2021
Understanding and minimizing injection-site pai...
Biosimilars/Research |
Posted 05/02/2021
Biosimilars policy considerations in the US
Reports |
Posted 05/02/2021
Canada approves three teriparatide biosimilars...
Biosimilars/News |
Posted 05/02/2021
Biocon and Lupin launch generic tacrolimus caps...
Generics/News |
Posted 05/02/2021
Partnerships formed and extended between Isu Ab...
Pharma News |
Posted 05/02/2021
Top 10 most read GaBI Online articles in 2020
Pharma News |
Posted 29/01/2021
Clinical evidence for interchangeability of bio...
Biosimilars/Research |
Posted 29/01/2021
EMA recommends approval of insulin aspart biosi...
Biosimilars/News |
Posted 29/01/2021
FDA approves rituximab biosimilar Riabni
Biosimilars/News |
Posted 29/01/2021
US biosimilars reimbursement: Medicare and 340B
Reports |
Posted 29/01/2021
Italy publishes new guidelines on pricing and r...
Guidelines |
Posted 29/01/2021
New generics company to offer low-cost versions...
Generics/General |
Posted 29/01/2021
EMA and EU medicines regulatory joint five-year...
Policies & Legislation |
Posted 29/01/2021
Biosimilars and lack of resources
Biosimilars/Research |
Posted 22/01/2021
EMA recommends approval of adalimumab and insul...
Biosimilars/News |
Posted 22/01/2021
How organizations worldwide are producing HTA r...
Biosimilars/Research |
Posted 22/01/2021
Generics applications under review by EMA – Jan...
Generics/General |
Posted 22/01/2021
Key considerations for payers, employers and pa...
Reports |
Posted 22/01/2021
Canada approves heparin biosimilars Redesca and...
Biosimilars/News |
Posted 22/01/2021
FDA increases transparency of biosimilar applic...
Guidelines |
Posted 22/01/2021
Samsung biosimilars: denosumab clinical trials...
Biosimilars/General |
Posted 22/01/2021
Biosimilars and availability of reference products
Biosimilars/Research |
Posted 15/01/2021
Biosimilars applications under review by EMA –...
Biosimilars/General |
Posted 15/01/2021
EC approval for pegfilgrastim biosimilar Nyvepria
Biosimilars/News |
Posted 15/01/2021
Influence of local policy measures and practice...
Biosimilars/Research |
Posted 15/01/2021
US guidance on proprietary names
Guidelines |
Posted 15/01/2021
Positive phase III results for sintilimab plus...
Biosimilars/Research |
Posted 15/01/2021
Perspectives of prescribing practices in public...
Generics/Research |
Posted 15/01/2021
Celltrion: Takeda acquisitions and new plant de...
Pharma News |
Posted 15/01/2021
Regulatory challenges with biosimilars
Biosimilars/Research |
Posted 08/01/2021
China approves adalimumab copy biological HLX03
Biosimilars/News |
Posted 08/01/2021
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 04/05/2017
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
Generics News Research General
- Adherence improves long-term prognosis and medi...Generics/Research | Posted 19/02/2021
- Anti-competitive strategic patenting by pharmac...Generics/Research | Posted 12/02/2021
- Biocon and Lupin launch generic tacrolimus caps...Generics/News | Posted 05/02/2021
- New generics company to offer low-cost versions...Generics/General | Posted 29/01/2021
Biosimilars News Research General
- Canada approves infliximab biosimilar Remsima SCBiosimilars/News | Posted 19/02/2021
- Innovent starts phase II trial for ipilimumab c...Biosimilars/News | Posted 19/02/2021
- EMA recommends approval of adalimumab biosimila...Biosimilars/News | Posted 12/02/2021
- Canada approves insulin aspart biosimilar TrurapiBiosimilars/News | Posted 12/02/2021