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EMA opens consultation on revision of biosimilar G-CSF guideline

On 27 July 2015, the European Medicines Agency (EMA) released a draft concept paper to discuss its planned revision of its specific guideline for biosimilars containing recombinant granulocyte colony-stimulating factor (G-CSF). The draft concept paper has been released for a three-month consultation period.

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.

Colombian guidelines for productos bioterapéuticos similares

Last update: 26 June 2015

The regulatory body for approval of medicines in Colombia is INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia’s National Institute of Food and Drug Monitoring. The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Colombia.

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 The draft guidance contains a question on the issue of interchangeability with reference biologicals.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Three years after first issuing draft guidance on biosimilars, the US Food and Drug Administration (FDA) has finally issued three final guidelines for biosimilar applications in the US.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).

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