Guidelines

FDA issues final guidance on naming biologicals

Home/Guidelines | Posted 27/01/2017

The US Food and Drug Administration (FDA) has issued final guidance detailing the agency’s requirements for the non-proprietary naming of biological products.

FDA issues draft guidance on biosimilar interchangeability

Home/Guidelines | Posted 20/01/2017

The US Food and Drug Administration (FDA) has finally issued its much anticipated guidance on the interchangeability of biosimilars with their reference biologicals.

FDA issues final guidance on pharmacology data for biosimilarity

Home/Guidelines | Posted 13/01/2017

The US Food and Drug Administration (FDA) on 29 December 2016 published final guidance outlining the clinical pharmacology data necessary to support a biosimilar application.

Biosimilars interchangeability guidance expected by end 2017

Home/Guidelines | Posted 14/10/2016

The US Food and Drug Administration (FDA) is not likely to produce draft guidance on interchangeability of biosimilars before the end of 2017.

FDA issues final guidance on pharmacology labelling

Home/Guidelines | Posted 09/12/2016

The US Food and Drug Administration (FDA) on 2 December 2016 published final guidance for completing the clinical pharmacology section of labelling for human prescription drugs, which includes originator drugs, generics and biologicals.

FDA releases 67 new and revised bioequivalence guidelines for generics

Home/Guidelines | Posted 18/11/2016

As part of its ongoing efforts to provide product specific guidance for generics makers the US Food and Drug Administration (FDA) has again released a whole host of new bioequivalence documents. The agency announced on 1 October 2016 that it had released 34 new draft guidance documents and 33 revisions to guidance documents on bioequivalence requirements for the development of generics containing 59 different active ingredients.

FDA issues guidance on self-identification for generics makers

Home/Guidelines | Posted 04/11/2016

The US Food and Drug Administration (FDA) announced on 22 September 2016 that it had published a guidance document clarifying its expectations on self-identification for generics makers.

Regulations for biosimilars in South Korea

Home/Guidelines | Posted 10/04/2015

The legislative basis for the regulation of biosimilars and its guideline for evaluation of biosimilars in South Korea was established in 2009 [1, 2].

Naming requirements in Australian biosimilars guidance

Home/Guidelines | Posted 04/10/2013

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), published specific guidance for biosimilars on its website on 30 July 2013. Included in this guidance is a section on naming conventions for biosimilars.

Australia issues new biosimilars guidance

Home/Guidelines | Posted 23/08/2013

Australia’s regulatory body, the Therapeutic Goods Administration (TGA) published specific guidance for biosimilars on its website on 30 July 2013.

Development and regulation of biosimilars in Japan

Home/Guidelines | Posted 16/08/2013

In Japan, a biosimilar product is defined as a biotechnological drug product developed by a different company that is comparable to the approved biotechnology-derived product (reference product) of an innovator company [1, 2].

South Korean guidelines for biosimilars

Home/Guidelines | Posted 09/03/2012

Last update: 10 April 2015

The regulatory body for approval of medicines in South Korea is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration. The agency, through its Biopharmaceuticals and Herbal Medicines Bureau, is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the South Korea.

ACR asked for guidelines on biosimilar substitution

Home/Guidelines | Posted 28/10/2016

At the US Food and Drug Administration’s (FDA) latest meeting on Biosimilar User Fee Act Reauthorization (BsUFA II), the American College of Rheumatology (ACR) asked FDA to create guidelines for biosimilar substitution.

Japanese guidelines for biosimilars

Home/Guidelines | Posted 06/06/2011

Last update: 21 October 2016

The Ministry for Health Labour and Welfare (MHLW) is the regulatory body in Japan responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Japan and makes the decision on approval of drugs, including biologicals.

Australia to adopt EMA generics guidelines

Home/Guidelines | Posted 07/10/2016

The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 10 April 2015 that it was carrying out public consultations on the adoption of European Union (EU) guidelines in Australia.

FDA releases new bioequivalence guideline for fidaxomin generics

Home/Guidelines | Posted 30/09/2016

The US Food and Drug Administration (FDA) announced on 29 August 2016 that it had released a new draft guidance document for generics of fidaxomicin.

FDA on interchangeability and demonstrating biosimilarity

Home/Guidelines | Posted 16/09/2016

The US Food and Drug Administration (FDA) intends to clarify its expectations for demonstrating the interchangeability of biosimilars with their reference biologicals, according to Dr Steven Kozlowski, Director of the Office of Biotechnology Products at FDA.

IPRF issues draft reflection paper for biosimilars extrapolation

Home/Guidelines | Posted 09/09/2016

The Biosimilars Working Group (BWG) of the International Pharmaceutical Regulators Forum (IPRF) announced on 6 September 2016 that it had released a draft reflection paper on the extrapolation of indications in the authorization of biosimilars.

EMA adopts new guidance on monitoring of biologicals

Home/Guidelines | Posted 02/09/2016

The European Medicines Agency (EMA) announced on 15 August 2016 that it had introduced a new guideline on the monitoring of biologicals, including biosimilars.

Europe to revise drug similarity concept under orphan legislation

Home/Guidelines | Posted 12/08/2016

The European Commission announced on 27 July 2016 a proposal to review the concept of ‘similar medicinal products’ in the context of the orphan legislation.

FDA withdraws biosimilar suffix proposal

Home/Guidelines | Posted 29/07/2016

The US Food and Drug Administration (FDA) has announced that it is withdrawing a request for comments on expanding the number of suffixes biosimilars makers can propose.

FDA asks for input on product-specific generics guidelines

Home/Guidelines | Posted 24/06/2016

In order to further facilitate the availability of generics and to assist the generics industry with identifying the most appropriate methodology for developing drugs, the US Food and Drug Administration (FDA) has released 19 new draft guidance documents and 19 revisions to guidance documents.

Biosimilarity statement unnecessary according to industry

Home/Guidelines | Posted 17/06/2016

Industry groups have expressed concerns about the proposal for a biosimilarity statement in the US Food and Drug Administration’s (FDA) draft guidance on biosimilar labelling.

Updated guideline on the use of epoetin and darbepoetin in cancer patients

Home/Guidelines | Posted 17/05/2013

Patients undergoing chemotherapy for cancer can often become anaemic as their red blood cell counts, and hence iron levels, fall. Besides the traditional approach of offering blood transfusion in order to restore iron levels, physicians can now treat patients with drugs that stimulate red blood cell development – known as erythropoiesis-stimulating agents (ESAs). Both treatments can boost iron-containing haemoglobin (Hb) levels, but they also pose risks to the patients. With transfusions, patients are at risk from serious infections and immune-mediated adverse events, while with ESAs; there is an increased risk of thromboembolism and death from other (but poorly understood) causes [1].

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