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Biological large Hanyang Univ V15c13

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.

Health and Safety V15C26

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.

Concept Paper

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.

Biologicals 1 NAME V13J31

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.

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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the most appropriate methodology for developing drugs, the US Food and Drug Administration (FDA) has released 19 new draft guidance documents and 19 revisions to guidance documents.

Checklist V14A17

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expressed concerns about the proposal for a biosimilarity statement in the US Food and Drug Administration’s (FDA) draft guidance on biosimilar labelling.

Anaemia V13D05

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].

Suffix V16F10

FDA increases number of biological suffix proposals

Home/Guidelines | Posted 10/06/2016

The US Food and Drug Administration (FDA) has announced a slight change to its guidance on naming biologicals, which will allow companies to propose up to 10 suffixes for each new biological or biosimilar. The agency announced the change in a Federal Register notice released on 2 June 2016.

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EMA releases reflection paper for generic oral immediate release products

Home/Guidelines | Posted 20/05/2016

The European Medicines Agency (EMA) announced on 13 May 2016 the publication of draft guidance on the dissolution requirements for orally administered generics with immediate release characteristics.

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FDA issues guidance on data integrity and GMP

Home/Guidelines | Posted 06/05/2016

The recent flood of data integrity problems identified at the manufacturing sites of drugmakers from India, China and elsewhere has led the US Food and Drug Administration (FDA) to draft new guidance addressing the issue.

Label FDA V14b20

FDA issues draft guidance on biosimilars labelling

Home/Guidelines | Posted 15/04/2016

The US Food and Drug Administration (FDA) announced on 31 March 2016 that it had issued draft guidance for industry on labelling for biosimilars. The guidance is open for comment for a period of two months.

India-Biotech Dept V13K29

India releases revised guidelines for ‘similar biologics’

Home/Guidelines | Posted 08/04/2016

On 26 March 2016, India’s Central Drugs Standard Control Organization (CDSCO) announced the release of proposed revised guidance for ‘similar biologics’ in India.

Guidance V13F21

EMA publishes guidance on publication of clinical trials data

Home/Guidelines | Posted 11/03/2016

The European Medicines Agency (EMA) announced on 3 March 2016 the publication of detailed guidance on the requirements for pharmaceutical companies to comply with the agency’s policy on publication of clinical trials data for medicines.

Remsima V14A10

BSG guidance recommends switching to biosimilar infliximab

Home/Guidelines | Posted 26/02/2016

The British Society of Gastroenterology (BSG) released new guidance in February 2016 recommending that stable patients be switched to biosimilar infliximab (CT-P13).

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FDA releases 47 new and revised bioequivalence guidelines for generics

Home/Guidelines | Posted 19/02/2016

Generics makers have a whole host of new bioequivalence documents to go through. The US Food and Drug Administration (FDA) announced on 27 January 2016 that it had released 35 new draft guidance documents and 12 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.

Review committee V15a16

FDA finalizes guidance for biosimilars meetings

Home/Guidelines | Posted 29/01/2016

The US Food and Drug Administration (FDA) announced on 18 November 2015 that it had finalized its guidance for industry on formal meetings between the FDA and biosimilars sponsors.

Canada V16A15

Health Canada issues draft revised SEB guideline

Home/Guidelines | Posted 15/01/2016

Canada’s federal department responsible for health, Health Canada, has issued a new draft revised guidance document on the information and submission requirements for subsequent entry biologics (SEBs). The draft guideline, issued on 7 December 2015, provides guidance to sponsors to enable them to satisfy the information and regulatory requirements under the Food and Drugs Act and Regulations for the authorization of SEBs in Canada.

Guidance V13F21

EMA to revise biosimilar interferon alfa guidance

Home/Guidelines | Posted 08/01/2016

On 4 January 2016, the European Medicines Agency (EMA) released a draft concept paper on the revision of the reflection paper on non-clinical and clinical development of interferon alfa biosimilars. The draft will be released for a three-month consultation period by the pharmaceutical industry and competent authorities of the Member States, as well as by the Committee for Medicinal Products for Human Use (CHMP) and its working parties.