Guidelines
Australia to adopt EMA’s biosimilars guidelines
The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 10 April 2015 that it was carrying out public consultations on the adoption of European Union (EU) guidelines in Australia.
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Three years after first issuing draft guidance on biosimilars, the US Food and Drug Administration (FDA) has finally issued three final guidelines for biosimilar applications in the US.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).
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.
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.
