Biosimilars/General

American dermatologists update position statement on biosimilar substitution

Biosimilars/General | Posted 16/11/2012

On 3 November 2012, the American Academy of Dermatology (AAD) updated its position statement on generics and biosimilar substitution to reflect its views, in particular on interchangeability* and naming of biosimilars.

EMA definitions of generics and biosimilars

Biosimilars/General | Posted 21/10/2011

Confusion surrounding terms used in the global field of generics and biosimilars is a recognised problem. The members of the Biosimilar Medicinal Products Working Party at EMA have recently expressed the need to propose a more precise definition for biosimilars due to problems arising from imprecise usage of the term in the scientific literature and elsewhere [1].

Biosimilars applications under review by EMA

Biosimilars/General | Posted 19/10/2012

Last update: 11 January 2013

EMA is the body responsible for approval of biosimilars within the EU. A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or ‘reference drug’.

Teva asks FDA to delay approval of Biogen’s MS drug

Biosimilars/General | Posted 18/01/2013

Teva Pharmaceutical Industries (Teva) has petitioned FDA not to approve Biogen Idec’s (Biogen’s) investigational pill for treatment of multiple sclerosis, BG-12 (dimethyl fumarate), citing safety concerns.

EMA publishes revised biosimilar Q&A document for patients

Biosimilars/General | Posted 05/10/2012

On 27 September 2012 EMA published its revised Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public.

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

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.

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.

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.

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.

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.

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.

Source: iBio

Also noted on biosimilars: 6 April 2012

Biosimilars/General | Posted 06/04/2012

Amgen and AstraZeneca make monoclonal antibody deal
Biotech giant Amgen and pharma major AstraZeneca announced on 2 April 2012 an agreement to jointly develop and commercialise five monoclonal antibodies from Amgen’s clinical inflammation portfolio (AMG 139, AMG 157, AMG 181, AMG 557 and brodalumab [AMG 827]), which are expected to be used to treat inflammatory diseases.

As part of the deal AstraZeneca will make an upfront payment of US$50 million and the companies will then share both costs and profits. The collaboration will provide Amgen with additional resources to optimally progress its portfolio and Amgen will benefit from the strong respiratory, inflammation and asthma development expertise of MedImmune–AstraZeneca’s biologicals arm.

Related articles

Amgen finally jumps on biosimilars bandwagon

AstraZeneca expands its generics business with Indian agreements

Source: Amgen, AstraZeneca

BIO and GPhA support biosimilar and generic user fees

Biosimilars/General | Posted 06/04/2012

Both the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) have expressed their support of user fees for biosimilars and generics.

Biosimilars will not be able to use ANDA pathway to approval

Biosimilars/General | Posted 30/03/2012

FDA’s highly anticipated guidance for biosimilars finally arrived on 10 February 2012 with the release of three draft guidance documents [1]. Some have complained that the guidance is too vague, however, FDA’s denial of three citizen’s petitions have perhaps made some issues clearer.

FDA announces public hearing on biosimilars’ guidelines

Biosimilars/General | Posted 23/03/2012

FDA has announced a one-day public hearing to be held on 11 May 2012, in Silver Spring, Maryland, USA. During the meeting FDA hopes ‘to obtain input on recently issued draft guidelines relating to the development of biosimilar products.’

Also noted on biosimilars: 16 March 2012

Biosimilars/General | Posted 16/03/2012

Boehringer Ingelheim expands biologicals manufacturing capacity
Boehringer Ingelheim announced on 29 February 2012 the expansion of its biopharmaceutical development and manufacturing capabilities at its cell culture and microbial sites in Biberach, Germany and Vienna, Austria. The company has invested around Euros 17 million in order to improve good manufacturing practice and to expand cell banking, process science, cell line development and quality laboratories.

Source: Boehringer Ingelheim

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