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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FDA issues draft guidance on biosimilars labelling

The US Food and Drug Administration (FDA) announced on 31 March 2016 that it had issued draft guidance for industry on labelling for biosimilars.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.

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.

EMA publishes guidance on publication of clinical trials data

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.

BSG guidance recommends switching to biosimilar infliximab

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

FDA releases 47 new and revised bioequivalence guidelines for generics

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 The US Food and Drug Administration (FDA) announced on 27 January 2016 that it had released 35 new draft guidance documents and 12 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.

FDA finalizes guidance for biosimilars meetings

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.

Health Canada issues draft revised SEB guideline

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.

EMA to revise biosimilar interferon alfa guidance

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.

EU guidelines for biosimilars

Last update: 8 January 2016

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.

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