Home / Guidelines

Guidelines

EMA issues finalized insulin biosimilars guideline

In March 2015, the European Medicines Agency (EMA) released its finalized guideline on the non-clinical and clinical development of insulin biosimilars.

Mexican guidelines for biocomparables

Last update:  27 March 2015

The regulatory body for approval of medicines in Mexico is the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). The agency is a decentralized organ of the Department of Health with technical, administrative and operational autonomy. The agency is responsible for protecting the Mexican population against sanitary risks, through sanitary regulation, control and promotion.

FDA plans to release four biosimilar guidances during 2015

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to release four new guidance documents on biosimilars during calendar year 2015.

Mexico issues rules on biolimbos

The Mexican regulatory body for approval of medicines, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), has issued rules for older non-originator biologicals registered prior to 19 October 2011, when the country’s guidelines for biocomparables were first published, mandating that companies conduct clinical trials to prove biosimilarity.

FDA calls for comment on generics user fees guidelines

The US Food and Drug Administration (FDA) announced in a Federal register publication of 6 February 2015 the reopening of the docket to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and the GDUFA Commitment Letter that accompanies the legislation.

FDA calls for comment on biosimilars interchangeability

The US Food and Drug Administration (FDA) wants drugmakers to comment on the information requirements for biosimilars interchangeability.

FDA releases 53 new and revised bioequivalence guidelines for generics

On 12 December 2014, the US Food and Drug Administration (FDA) released 31 new draft guidance documents and 22 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.

Australia reviewing plans for naming biosimilars

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has changed its plans for naming biosimilars, ‘following recent international developments in the area of biosimilar naming’.

EU guidelines for biosimilars

Last update: 23 January 2015

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.

EMA issues revised guideline on non-clinical and clinical issues for biosimilars

On 18 December 2014, the European Medicines Agency (EMA) published the new version of its guideline addressing the non-clinical and clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance. This new guideline will revise the agency’s 2006 overarching guideline on the non-clinical and clinical issues related to similar biological medicinal products.

Generics News Research General

more

Biosimilars News Research General

more