Reports
Hungarian experience with the use of biosimilar infliximab in IBD
In a study of real life experience with biosimilar infliximab CT‑P13 the results suggest high response and remission rates similar to those previously reported with the originator biological [1].
US pharmacy benefit firm suggests rebates are not driving drug price rises
Drug pricing has become a prominent political issue in recent years, and especially in the US. High prices for new drugs and continuous increases for older branded drugs (and even generic drugs) have generated negative publicity for drugmakers, and in some cases even official investigations. In response to this, pharmaceutical companies have begun to make pledges on prices. Several have suggested that rises are due to other factors such as insurance costs and rebates paid to pharmacy benefits management (PBM) companies (third party administrators of prescription drug programmes).
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.
