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Pay for Delay DrugsMoneyGeneric V13F21

Study undermines pharmaceutical industry’s justification for high pricing in the US

Home/Reports | Posted 28/04/2017

A recent report in Health Affairs suggests that drug prices in the US generate significantly more revenue than their development costs, dismantling a common argument put forward by the pharmaceutical industry.

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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
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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.

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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].

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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).

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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.

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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.

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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].

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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.

Clinical Trials 2 V13K29

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.

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Changes in quality data and non-clinical studies for biosimilars

Home/Reports | Posted 03/02/2017

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).

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Changes in requirements for reference products for biosimilars

Home/Reports | Posted 20/01/2017

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.

Clinical Trials 2 V13K29

Pivotal clinical trials for adalimumab biosimilars

Home/Reports | Posted 28/08/2015

Biosimilars of AbbVie’s Humira (adalimumab), a human monoclonal antibody, are currently under development.

Pay for Delay DrugsMoneyGeneric V13F21

Biosimilars could save US$44.2 billion over 10 years

Home/Reports | Posted 09/01/2015

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.

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Biosimilars applications reviewed in the EU

Home/Reports | Posted 06/01/2017

The European Union (EU) was the first to establish a legal framework for biosimilars back in 2003 [1]. Since the European Medicines Agency (EMA) approved its first biosimilars in 2006 the agency has issued new guidelines and updated its existing guidelines based on new evidence and rapid advances in analytical sciences [2].

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Demonstrating biosimilarity in the EU

Home/Reports | Posted 09/12/2016

How has the European Medicines Agency (EMA) changed its requirements for biosimilars since it first approved biosimilars in 2006? This is a question raised by Dr Martina Weise, Head of the Licensing Division at the Federal Institute for Drugs and Medical Devices (BfArM).

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Joint GMP inspections by EMA and FDA discussed as part of TTIP

Home/Reports | Posted 02/12/2016

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) could be carrying out joint inspections for good manufacturing practices (GMPs) as early as January 2017.

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Transparency and quality characteristics for biosimilars

Home/Reports | Posted 18/11/2016

Under the auspices of increased transparency for biosimilars the European Medicines Agency (EMA) has outlined the different means available for publishing quality information on biosimilars.

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The role of the IPRF in transparency for biosimilars

Home/Reports | Posted 11/11/2016

The purpose of the International Pharmaceutical Regulators Forum (IPRF) is to create an environment for pharmaceutical regulators to exchange information on issues of mutual concern and to foster regulatory cooperation. The organization’s Biosimilars Working Group (BWG) is one of five working groups that have been established to address specific issues.