Reports
Revised Q&As on biosimilars for patients
During the European Commission’s (EC) second workshop on biosimilars, which was held in Brussels, Belgium on 20 June 2016 [1], the EC presented its new revised question and answer (Q&A) document on biosimilars for patients.
Closing the information gap for biosimilars
The importance of providing information on biosimilars to patients and prescribers was a topic discussed during the European Commission’s (EC) second Multi-stakeholder Workshop on Biosimilar Medicinal Products, which was held in Brussels, Belgium on 20 June 2016 [1].
National experience with biologicals, including biosimilars
The European Commission (EC) held its second Multi-stakeholder Workshop on Biosimilar Medicinal Products in Brussels, Belgium on 20 June 2016 [1]. The aim of such workshop is to encourage timely access to biosimilars in Europe.
EC workshop on biosimilars aims to improve uptake
With the aim of encouraging timely access to biosimilars in Europe, the European Commission (EC) held its second Multi-stakeholder Workshop on Biosimilar Medicinal Products in Brussels, Belgium on 20 June 2016 [1].
Extrapolation and pharmacovigilance for biosimilars
The issues of extrapolation and pharmacovigilance for biosimilars were discussed in the presentation [1] of Dr Dr Martina Weise, Head of the Licensing Division at the Federal Institute for Drugs and Medical Devices (BfArM), at the 14th Annual Biosimilar Medicines Group Conference.
Tailored and reduced clinical programme for biosimilars
The European Medicines Agency (EMA) is constantly issuing new guidelines and updating its existing guidelines based on new evidence and rapid advances in analytical sciences. Dr Martina Weise, Head of the Licensing Division at the Federal Institute for Drugs and Medical Devices (BfArM), discussed tailored and reduced clinical programme for biosimilarsin the European Union (EU) in her presentation [1] at the 14th Annual Biosimilar Medicines Group Conference.
Changes in quality data and non-clinical studies for biosimilars
Since it first developed guidelines for the approval of biosimilars via an abbreviated registration process during 2005 to 2006, the European Medicines Agency (EMA) has issued new guidelines and updated its existing guidelines based on new evidence and rapid advances in analytical sciences. In her presentation [1] at the 14th Annual Biosimilar Medicines Group Conference, Dr Martina Weise, Head of the Licensing Division at the Federal Institute for Drugs and Medical Devices (BfArM), discussed the changes in data requirements introduced in the European Union (EU).
Changes in requirements for reference products for biosimilars
In her presentation [1] at the 14th Annual Biosimilar Medicines Group Conference, Dr Martina Weise, Head of the Licensing Division at the Federal Institute for Drugs and Medical Devices (BfArM), discussed the changes in data requirements introduced in the European Union (EU) since it first developed guidelines for the approval of biosimilars via an abbreviated registration process during 2005 to 2006.
Pivotal clinical trials for adalimumab biosimilars
Biosimilars of AbbVie’s Humira (adalimumab), a human monoclonal antibody, are currently under development.
Biosimilars could save US$44.2 billion over 10 years
Introducing biosimilars of complex biologicals used to treat illnesses such as cancer and rheumatoid arthritis could cut spending on biologicals in the US by US$44 billion over the next decade, according to an analysis carried out by the RAND Corporation.
