Reports

Biosimilarity is not interchangeability

Home/Reports | Posted 21/04/2017

The following key considerations for interchangeabilty should be addressed before any biosimilar is designated as interchangeable, according to Dr Brad Jordan, Director of Global Regulatory and R & D Policy at Amgen [1]:

Policies should address medically-guided and pharmacy mediated scenarios
Decisions should be based on product-specific evidence
Patients and prescribers should have options and input
Policies and practices should support product-specific pharmacovigilance

The evolution of biosimilars in the US

Home/Reports | Posted 07/04/2017

The US has come a long way since the introduction of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was signed into law on 23 March 2010 by President Barack Obama.

Hungarian experience with the use of biosimilar infliximab in IBD

Home/Reports | Posted 31/03/2017

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

Home/Reports | Posted 24/03/2017

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

Home/Reports | Posted 17/03/2017

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

Home/Reports | Posted 10/03/2017

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

Home/Reports | Posted 03/03/2017

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

Home/Reports | Posted 24/02/2017

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

Home/Reports | Posted 17/02/2017

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

Home/Reports | Posted 10/02/2017

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.