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FDA to hold public meeting on GDUFA

The US Food and Drug Administration (FDA) is seeking specific suggestions on potential changes to the Generic Drug User Fee Act (GDUFA) performance goals and ways to improve procedures, ahead of negotiations to reauthorize the law.

FDA finalizes biosimilars guidelines

Three years after first issuing draft guidance on biosimilars, the US Food and Drug Administration (FDA) has finally issued three final guidelines for biosimilar applications in the US. The guidances, however, fail to address the issue of interchangeability with reference biologicals, which the agency says it will address in another document.

EMA rejects comparators from outside EEA for insulin biosimilars

The European Medicines Agency (EMA) released its finalized guideline on the non-clinical and clinical development of insulin biosimilars in March 2015 [1]. However, while the guidance took into account many of the comments made by stakeholders on the second draft, the agency rejected requests to accept batches of reference (approved) biological products sourced from outside the European Economic Area (EEA).

South Korean guidelines for biosimilars

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.

Regulations for biosimilars in South Korea

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

FDA guidance on excipients questioned

The International Pharmaceutical Excipient Council of the Americas (IPEC-Americas) has written to the US Food and Drug Administration (FDA) outlining major concerns related to the agency’s guidance on inactive ingredients in abbreviated new drug applications (ANDAs).

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.