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Health Canada issues draft revised SEB guideline

Canada’s federal department responsible for health, Health Canada, has issued a new draft revised guidance document on the information and submission requirements for subsequent entry biologics (SEBs). The draft guideline, issued on 7 December 2015, provides guidance to sponsors to enable them to satisfy the information and regulatory requirements under the Food and Drugs Act and Regulations for the authorization of SEBs in Canada.

EMA to revise biosimilar interferon alfa guidance

On 4 January 2016, the European Medicines Agency (EMA) released a draft concept paper on the revision of the reflection paper on non-clinical and clinical development of interferon alfa biosimilars. The draft will be released for a three-month consultation period by the pharmaceutical industry and competent authorities of the Member States, as well as by the Committee for Medicinal Products for Human Use (CHMP) and its working parties.

EU guidelines for biosimilars

Last update: 8 January 2016

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.

FDA issues final guidance on generics information requests

The US Food and Drug Administration (FDA) issued final guidance for generics makers on how to make formal requests for information. The final guideline, issued on 29 September 2015, provides information regarding the process by which generics makers can submit correspondence to FDA requesting information on generics development.

India to revise ‘similar biologics’ guideline

The Indian Ministry of Health is planning to revise its guidelines for approving ‘similar biologics’. The ministry aims to make the regulatory pathway more robust and to align the guidelines further with global guidelines for biosimilars.

GPhA challenges FDA guidance on size and shape of generic pills

In June 2015, the US Food and Drug Administration (FDA) published guidance on the size, shape and other physical attributes of generic tablets and capsules [1]. However, the Generic Pharmaceutical Association (GPhA) has raised a number of concerns about the guidance.

FDA to hold public meeting on reauthorization of BsUFA

The US Food and Drug Administration (FDA) is seeking specific suggestions on potential changes to the Biosimilar User Fee Act (BsUFA) performance goals ahead of negotiations to reauthorize the law.

FDA defends lack of biosimilars guidelines

The US Food and Drug Administration’s (FDA) director for the Center for Drug Evaluation and Research (CDER) Dr Janet Woodcock, told senators on 17 September 2015 that a critical part of launching a robust US biosimilars market and setting up the regulations to support it is to make sure the scientific framework is ‘bulletproof’.

FDA issues draft guidance on naming biologicals

The US Food and Drug Administration (FDA) has issued another draft guidance for biosimilars. The draft guideline, issued on 27 August 2015, details the FDA’s proposal on the non-proprietary naming of biological products.

FDA releases 48 new and revised bioequivalence guidelines for generics

The US Food and Drug Administration (FDA) has released 44 new draft guidance documents and four revisions to guidance documents on bioequivalence requirements for the development of generics containing 46 different active ingredients.