Guidelines

FDA defends lack of biosimilars guidelines

The US Food and Drug Administration’s (FDA) director for the Center for Drug Evaluation and Research (CDER) Dr Janet Woodcock, told senators on 17 September 2015 that a critical part of launching a robust US biosimilars market and setting up the regulations to support it is to make sure the scientific framework is ‘bulletproof’.

FDA issues draft guidance on naming biologicals

The US Food and Drug Administration (FDA) has issued another draft guidance for biosimilars. The draft guideline, issued on 27 August 2015, details the FDA’s proposal on the non-proprietary naming of biological products.

FDA releases 48 new and revised bioequivalence guidelines for generics

The US Food and Drug Administration (FDA) has released 44 new draft guidance documents and four revisions to guidance documents on bioequivalence requirements for the development of generics containing 46 different active ingredients. 

FDA wants generics to be physically same as originators

Until now generics have been required to be pharmaceutically equivalent and bioequivalent to the brand-name drug, however, generics made by different manufacturers could differ substantially from their brand-name therapeutic equivalents and from each other in their physical appearance, e.g. colour, shape or size of pills. The US Food and Drug Administration (FDA), aims to change this, with guidance issued in June 2015 recommending that the physical properties, including the size, shape and colour, of generics should be similar to those of their reference drugs.

US guidelines for generics

Last update: 14 August 2015

The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).

Australia implements EMA’s biosimilars guidelines

The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 3 June 2015 that it had adopted ten European Union (EU) guidelines in Australia.

EMA opens consultation on revision of biosimilar G-CSF guideline

On 27 July 2015, the European Medicines Agency (EMA) released a draft concept paper to discuss its planned revision of its specific guideline for biosimilars containing recombinant granulocyte colony-stimulating factor (G-CSF). The draft concept paper has been released for a three-month consultation period.

FDA outlines details of surveys into physical differences in generics

The US Food and Drug Administration (FDA) in a Federal Register notice published on 14 May 2015 has outlined how it will carry out pharmacist and patient surveys into how changes in the physical characteristics of generics pills affect patients’ perceptions.

Colombia issues further draft guidelines for biologicals

The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) announced on 12 May 2015 the release of a new draft guideline on stability of biologicals in Colombia. The country also published a draft guideline on Good Manufacturing Practices (GMP) for biologicals on 17 April 2015.

FDA issues another biosimilars Q&A guidance

On 13 May 2015, the US Food and Drug Administration (FDA) issued another question and answer guidance document for biosimilar applications in the US. The draft guidance contains a question on the issue of interchangeability with reference biologicals.