Guidelines
FDA outlines details of surveys into physical differences in generics
The US Food and Drug Administration (FDA) in a Federal Register notice published on 14 May 2015 has outlined how it will carry out pharmacist and patient surveys into how changes in the physical characteristics of generics pills affect patients’ perceptions.
Colombia issues further draft guidelines for biologicals
The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) announced on 12 May 2015 the release of a new draft guideline on stability of biologicals in Colombia. The country also published a draft guideline on Good Manufacturing Practices (GMP) for biologicals on 17 April 2015.
FDA issues another biosimilars Q&A guidance
On 13 May 2015, the US Food and Drug Administration (FDA) issued another question and answer guidance document for biosimilar applications in the US. The draft guidance contains a question on the issue of interchangeability with reference biologicals.
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Three years after first issuing draft guidance on biosimilars, the US Food and Drug Administration (FDA) has finally issued three final guidelines for biosimilar applications in the US.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.
