Home / Guidelines

Guidelines

FDA withdraws biosimilar suffix proposal

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

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the most appropriate methodology for developing drugs, the US Food and Drug Administration (FDA) has released 19 new draft guidance documents and 19 revisions to guidance documents.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

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expressed concerns about the proposal for a biosimilarity statement in the US Food and Drug Administration’s (FDA) draft guidance on biosimilar labelling.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

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].

FDA increases number of biological suffix proposals

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.

EMA releases reflection paper for generic oral immediate release products

The European Medicines Agency (EMA) announced on 13 May 2016 the publication of draft guidance on the dissolution requirements for orally administered generics with immediate release characteristics.

FDA issues guidance on data integrity and GMP

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.

FDA issues draft guidance on biosimilars labelling

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.

Indian guidelines for ‘similar biologics’

Last update:  15 April 2016

The regulatory bodies responsible for approval of ‘similar biologics’ in India are the Department of Biotechnology (DBT) under the Ministry of Science and Technology through its Review Committee on Genetic Manipulation (RCGM), and the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.

India releases revised guidelines for ‘similar biologics’

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