Biosimilars

Highs and lows for biosimilars during 2009/2010

Biosimilars/General | Posted 17/09/2010

A lot has happened in the biosimilars’ industry during 2009/2010.

Dr Reddy’s launches biosimilar Aranesp

Biosimilars/News | Posted 17/09/2010

Dr Reddy’s Laboratories increases its stake in the biosimilars’ market with the latest launch in India from its biosimilars’ programme. Cresp is the first generic darbepoetin alfa in the world, and the only darbepoetin alfa in India. Darbepoetin alfa is used for the treatment of anaemia due to chronic kidney disease and chemotherapy.

Good news for biosimilar enoxaparin sodium

Biosimilars/News | Posted 03/09/2010

French pharma giant sanofi-aventis (sanofi) has been denied a request to block sales of a generic version of its Lovenox blood thinner by a US district court.

How far does similarity go?

Biosimilars/Research | Posted 25/08/2010

How much similarity does a biosimilar monoclonal antibody (mAb) have to show to its reference mAb? The European overarching biosimilar guideline states that a biosimilar needs to be ‘similar, in molecular and biological terms, to the active substance of the reference medicinal product.’ The guideline gives an example to highlight this, stating that an interferon alfa-2b would not be acceptable as a reference product to a biosimilar interferon alfa-2a1. Because interferon alfa-2a and alfa-2b differ in only one amino acid, the guideline thus indicates that the entire amino acid sequence of the two molecules should be identical.

What clinical trials will be required for biosimilar mAbs?

Biosimilars/Research | Posted 25/08/2010

The relevant European guideline states that if the reference medicinal product has more than one indication, the efficacy and safety of a biosimilar has to be justified, if necessary by demonstrating it separately for each indication claimed. The guideline brings up the possibility of ‘extrapolating’ efficacy (granting several clinical indications that are licensed for the reference product, although only one of the indications has been studied in the clinical development programme of the biosimilar). This would not be done without serious consideration. The mechanism of action of monoclonal antibodies (mAbs) is usually complex and in many cases only partially understood.

Technical challenges in defining mAbs

Biosimilars/Research | Posted 25/08/2010

Monoclonal antibodies (mAbs) are highly complex molecules with secondary and tertiary structures. The drug substance (the molecule itself) and drug product (the pharmaceutically formulated final product) are heterogeneous, i.e. a mixture of several slightly different structures. Although the molecular characterisation of a mAb molecule itself might have reached a high level of precision, reliability, quality and reproducibility, various possibilities for mAb heterogeneity exist. Variations to the mAb protein include alternative disulfide pairings/disulfide shuffling, deamidation, (methionine) oxidation, cyclisation of N-terminal glutamine residues and partial enzymatic cleavage during manufacturing. Variations of post-translational modifications such as glycosylation patterns include differential addition of sugars, alternative branching of sugar chains and others. Physicochemical characterisation of these characteristics currently remains cumbersome.

Phase I trial of a biosimilar erythropoietin

Biosimilars/Research | Posted 25/08/2010

A Phase I clinical trial of Hospira’s biosimilar erythropoietin (EPO) in patients with anaemia associated with chronic renal failure and chemotherapy has started in the US.

FDA approves first biosimilar enoxaparin sodium

Biosimilars/News | Posted 13/08/2010

On 23 July 2010, Momenta Pharmaceuticals and Sandoz announced that they had received approval from the FDA for their biosimilar version of sanofi-aventis’s (sanofi-aventis’s ) blockbuster blood thinning drug, Lovenox (enoxaparin sodium).

The biosimilars challenge

Biosimilars/Research | Posted 30/07/2010

What are the challenges facing biosimilars? This was the question broached in a paper by Professor Håkan Mellstedt of the Department of Oncology, at the Karolinska University Hospital Solna, Stockholm, Sweden.

Challenges in the development of biosimilars mAbs

Biosimilars/Research | Posted 02/07/2010

What are the challenges facing development of biosimilar monoclonal antibodies (mAbs) in Europe? This was the question broached in a paper by Dr Christian Schneider – Chairman of both the Committee for Advanced Therapies and Biosimilar Medicinal Products Working Party and Co-opted member of the Committee for Medicinal Products for Human Use.

Development of biosimilars mAbs

Biosimilars/Research | Posted 02/07/2010

Is the development of biosimilar monoclonal antibodies (mAbs) possible in Europe? This was the question broached in a paper by Dr Christian Schneider – Chairman of both the Committee for Advanced Therapies and Biosimilar Medicinal Products Working Party and Co-opted member of the Committee for Medicinal Products for Human Use.

Cipla enters the biosimilars market

Biosimilars/News | Posted 02/07/2010

India-based generics’ manufacturer Cipla is paying US$65 million to buy a significant minority stake in two Asian biotech companies with plans to develop a range of discounted biosimilars, generic substitutable versions of branded biologic drugs. Cipla's Chairman says he specifically wants to create follow-on therapies to three of Roche's top biologics – Avastin, Enbrel and Herceptin – that account annually for US$19 billion in sales.

Hospira’s biosimilar filgrastim product Nivestim approved

Biosimilars/News | Posted 25/06/2010

On 10 June 2010, Hospira received approval from the European Commission for its biosimilar filgrastim product, Nivestim, for the prevention of febrile neutropenia and reduction in duration of chemotherapy-induced neutropenia.

Phase III study of a new biosimilar filgrastim product (Zarzio) published

Biosimilars/Research | Posted 04/06/2010

A biosimilar recombinant human granulocyte colony-stimulating factor (filgrastim) (rhG-CSF), Zarzio (Sandoz GmbH), was evaluated in healthy volunteers in four phase I studies and in neutropenic patients in a phase III study.

Phase I studies of a new biosimilar filgrastim product (Zarzio) published

Biosimilars/Research | Posted 04/06/2010

Zarzio (Sandoz GmbH), a biosimilar recombinant human granulocyte colony-stimulating factor (filgrastim), was evaluated in healthy volunteers in four phase I studies and in neutropenic patients in a phase III study.

Development of a new biosimilar filgrastim product (Zarzio)

Biosimilars/News | Posted 04/06/2010

Filgrastim, a growth factor, is used to aid the recovery of bone marrow after chemotherapy treatment for cancer, especially in patients with neutropenia (low white blood cell count in the blood), causing reduced host defence.

Include health economics in development of biosimilars

Biosimilars/Research | Posted 15/04/2010

The early inclusion of health economics in the process of developing biopharmaceuticals and biosimilars is imperative with a view to demonstrating their relative (cost) effectiveness and informing registration, pricing and reimbursement decisions, writes Professor Steven Simoens of the Katholieke Universiteit Leuven, Belgium, in the Journal of Medical Economics in 2009.

In the article he discusses health economic challenges of research and development, registration, pricing and reimbursement of biopharmaceuticals and biosimilars. Professor Simoens identified relevant studies by searching PubMed, Centre for Reviews and Dissemination databases (Database of Abstracts of Reviews of Effects, National Health Service Economic Evaluation Database, and Health Technology Assessments Database), Cochrane Database of Systematic Reviews and EconLit up to March 2009. Additionally, the bibliography of included studies was checked for other relevant studies.

Health Canada issues finalised guidance on biosimilars

Biosimilars/News | Posted 13/04/2010

Health Canada has released the finalised version of its Guidance Document on the approval of Subsequent Entry Biologics (SEBs), which is effective as of 5 March 2010.

Global Industry Analysts: Global biosimilars market to exceed US$2 billion by 2015

Biosimilars/General | Posted 09/04/2010

On 24 March 2010, Global Industry Analysts (GIA) announced the release of a new report, entitled ‘Biosimilars: A Global Strategic Business Report’

Biosimilars mean competition for biologic brands

Biosimilars/General | Posted 09/04/2010

The historic passage of two US healthcare reform bills on 21 March 2010, including a US Senate bill with an approval pathway for biosimilars, means biologic brands could see rivals replicate and market similar products, writes Mr Marc Iskowitz in Medical Marketing & Media. According to him, the new legislation, signed by US president Mr Barack Obama on 23 March 2010, lays out a series of requirements for the FDA to consider follow-on biologics (FOBs) applications.