Reports
Biosimilars applications reviewed in the EU
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].
Demonstrating biosimilarity in the EU
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).
Joint GMP inspections by EMA and FDA discussed as part of TTIP
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.
Transparency and quality characteristics for biosimilars
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.
The role of the IPRF in transparency for biosimilars
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.
Achieving international regulatory convergence for biosimilars
In the 2000s both the European Union and the World Health Organization (WHO) published biosimilars guidelines. Since then, major regions have developed and adopted guidelines based on WHO’s standards for similar biotherapeutic products. Agencies that have now implemented biosimilars guidelines include Australia’s Therapeutic Goods Administration (TGA), Health Canada, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the US Food and Drug Administration (FDA).
FDA says trust and education critical for biosimilars
The US Food and Drug Administration (FDA) has highlighted trust and education as critical factors in ensuring patient access to biosimilars.
Extrapolation of indications for biosimilars in Japan
In his presentation at the 14th Annual Biosimilars Group Conference, Dr Daisaku Sato, Director, Office of Cellular and Tissue-based Products at the Pharmaceutical and Medical Devices Agency (PMDA), discussed extrapolation* of indications for biosimilars in Japan [1].
Potential cost savings from use of biosimilars in the UK
A new report into the use of biological therapies to treat inflammatory bowel disease (IBD) has found that biosimilars are safe and effective for patients and if adopted can halve the cost of treatment in the UK.
Naming and interchangeability for biosimilars in Japan
At the 14th Annual Biosimilars Group Conference, Dr Daisaku Sato, Director, Office of Cellular and Tissue-based Products at the Pharmaceutical and Medical Devices Agency (PMDA), discussed naming rules and interchangeability for biosimilars in Japan [1].
