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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.

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.