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Biosimilars/General

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Naming and interchangeability of biosimilars raised in new survey

Biosimilars/General | Posted 05/10/2012

The contentious issues of naming and interchangeability of biosimilars in the US have been raised once again, as a result of a survey carried out by the Alliance for Safe Biologic Medicines (ASBM). The survey, released on 13 September 2012, examined physician practices and perspectives with regard to identification and substitution of biosimilars. These remain issues that are as yet unresolved by FDA.

Also noted on biosimilars: 30 March 2012

Biosimilars/General | Posted 30/03/2012

Bioequivalence of biosimilar trastuzumab to Herceptin proven in phase I trial
Biopharmaceutical company Synthon announced on 22 March 2012 that all in vitro and in vivo studies conducted so far have shown the biosimilar behaviour of Synthon’s trastuzumab in comparison with the reference product, Herceptin. The outcome of the phase I clinical trial confirmed these results, showing bioequivalence of Synthon’s trastuzumab to Herceptin. Synthon confirmed that its biosimilar trastuzumab will now enter a confirmatory phase III clinical trial in breast cancer patients.

Source: Synthon

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FDA urged to exclude plasma protein therapies from biosimilar pathway

Biosimilars/General | Posted 03/08/2012

FDA is being lobbied by patient and industry groups to exclude plasma protein therapies from its pathway for the approval of biosimilars. FDA has a mandate to create a new abbreviated process for the approval of biosimilars under the Biologics Price Competition and Innovation Act of 2009, which was part of the new healthcare reform law passed in March 2010 [1]. This potentially brings cheaper products to market sooner, and so increases the availability of affordable health care. However, it also means that manufacturers applying for approval for new biosimilars may be able to skip clinical testing if they can demonstrate sufficient similarity with reference products.

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US supreme court ruling means biosimilars pathway safe

Biosimilars/General | Posted 06/07/2012

On 28 June 2012 the US Supreme Court ruled in favour of the bulk of the Affordable Care Act, meaning that the biosimilars pathway, which is part of the act, is now also safe.

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US Supreme Court looks set to challenge Affordable Care Act

Biosimilars/General | Posted 18/05/2012

The United States Supreme Court is reviewing the constitutionality of the provision in the Affordable Care Act providing that individuals should take personal responsibility for paying for their health care by obtaining health insurance or pay a fine. The move could mean that the Supreme Court rejects the whole healthcare law, including the biosimilars pathway created by the healthcare reform.

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Biosimilars approved and marketed in The Netherlands

Biosimilars/General | Posted 01/06/2012

Last updated: 1 June 2012

The Dutch Medicines Evaluation Board (MEB) – College ter Beoordeling van Geneesmiddelen (CBG) – is responsible for the approval of marketing authorisation of medicinal products including biosimilars in The Netherlands.

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FDA’s public hearing on biosimilars draft guidances

Biosimilars/General | Posted 25/05/2012

On 11 May 2012, FDA held a public hearing to gain input on their draft guidances relating to the development of biosimilar products and it seems that the guidances were generally well accepted.

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Biosimilars approved and marketed in Belgium

Biosimilars/General | Posted 18/05/2012

Last updated: 18 May 2012 

The Federal Agency for Medicines and Health Products (FAMHP), formerly the Directorate-General for Medicinal Products of the Federal Public Service (FPS) Public Health, created in January 2007, is the official authority for medicines and health products in Belgium and is also responsible for authorising biosimilars in Belgium [1]. This is carried out via the EU procedures (centralised, national, mutual recognition or decentralised) and following EMA guidelines for biosimilars.

Also noted on biosimilars: 11 May 2012

Biosimilars/General | Posted 11/05/2012

Sandoz testimony at FDA hearing on biosimilars will emphasise need for consistent regulatory standards across all biologicals
Sandoz announced on 9 May 2012 that Dr Mark McCamish, Head of Global Biopharmaceutical Development, would present on behalf of the Novartis Group of companies (Novartis) at the 11 May 2012 FDA public hearing on draft guidances for biosimilars.

The message he will convey will focus on the need for a single science-based regulatory standard that FDA should apply across all biologicals, irrespective of the business model of the sponsor. As well as a single standard, Dr McCamish will address the points that biosimilar clinical studies should be only confirmatory and the fact that interchangeability is critical to maximising access to affordable biosimilars for US patients.

Source: Sandoz

Also noted on biosimilars: 13 April 2012

Biosimilars/General | Posted 13/04/2012

Palivizumab biosimilar successfully produced in plants
Biotechnology company iBio, self-professed leader in the plant-made pharmaceutical field, announced on 10 April 2012 that it had successfully used its iBioLaunch technology to produce biosimilar palivizumab in non-transgenic green plants.

This is the second monoclonal antibody that the company has successfully produced. Back in October 2011 the company announced the successful use of its technology to produce rituximab.

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Rituximab biosimilar successfully produced in plants

Source: iBio