Guidelines
EMA releases product-specific bioequivalence guidelines
The European Medicines Agency (EMA) announced on 15 November 2013 the release of the agency’s first product-specific guidance on the demonstration of bioequivalence for 16 active substances. The draft guidelines have been released for a three-month public consultation period.
EU guidelines for nanosimilars
Last update: 5 November 2013
The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.
EMA issues draft reflection paper for iron-based nano-colloidal products
On 7 October 2013, the European Medicines Agency (EMA) announced the publication of a draft reflection paper‡ to discuss the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicine. The draft reflection paper has been released for a five-month consultation period.
FDA publishes guidance on ANDAs for new strengths
The US Food and Drug Administration (FDA) has published draft guidance for industry for abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) where the applicant is seeking approval of a new strength of the drug product.
EMA organizes workshop on biosimilars guidelines
The European Medicines Agency (EMA) announced on 25 September 2013 that the agency would be organizing a workshop on biosimilars.
EMA issues draft concept paper on comparing quality in biologicals and biosimilars
On 28 June 2013, the European Medicines Agency (EMA) released a draft concept paper to discuss the issue of how to compare the quality attributes for biological products and biosimilars. The draft concept paper has been released for a three-month consultation period.
Revision of guideline on clinical and non-clinical issues for biosimilars
On 10 June 2013, EMA released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance. The draft guideline has been released for a six-month consultation period.
EMA issues draft revision of overarching biosimilar guidelines
EMA announced on 2 May 2013 the publication of its new draft biosimilars guideline, which will revise the agency’s 2005 overarching guideline on similar biological medicinal products. The draft guideline has been released for a six-month consultation period.
FDA issues draft guidance for biosimilar meetings
FDA announced on 1 April 2013 that it had issued draft guidance for biosimilar meetings outlining standardized procedures for requesting, preparing, scheduling, conducting and documenting such formal meetings with FDA.
Guideline update on prevention of febrile neutropenia with G-CSF
Patients undergoing chemotherapy for cancer are at risk of developing the sometimes fatal condition of febrile neutropenia (FN), involving infection, fever and sepsis due to a loss of neutrophils. Prophylaxis with recombinant granulocyte colony-stimulating factor (G-CSF) has been shown to reduce hospital admissions, antibiotic use and the need for chemotherapy dose reduction. Several forms of recombinant G-CSF are available, including filgrastim and its biosimilars, or the pegylated version of filgrastim. All three are considered to be equivalent in terms of clinical efficacy and safety.
