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Biosimilars

Scientific and legal viability of follow-on protein drugs

Biosimilars/Research | Posted 05/08/2009

Since recombinant human insulin (Humulin) became the first recombinant-protein drug approved by the FDA 25 years ago, nearly 100 recombinant-protein therapeutics including other hormones and monoclonal antibodies, have become part of clinical practice. Though small-molecule drugs are more common than recombinant-protein drugs – only one of the top 200 prescribed drugs of 2006 (on the basis of prescription volume) was a recombinant protein – protein-based therapeutics have been used to treat diabetes and anaemia, as well as relatively rarer conditions, such as rheumatoid arthritis, Gaucher's disease, and multiple sclerosis.

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Economic issues with follow-on protein products

Biosimilars/Research | Posted 30/07/2009

The economic effects of the possible introduction of follow-on protein products have been the subject of recent debate. In a study by Mr Michael Lanthier, Ms Rachel Behrman and Mr Clark Nardinelli of the US FDA, it was aimed to explore the economic issues surrounding this debate using three measures: total sales, product complexity and patent expiry.

Biosimilar substitution: Listen to all lobbyists

Biosimilars/News | Posted 30/07/2009

In December 2007 a British parliamentary review was conducted on the issue of biosimilars. At a British meeting it was told that “automatic substitution rules do not apply to biologicals.” The recommendation of the panel was that “there should be an urgent ban on the substitution of biopharmaceuticals in the UK until effective safeguards can be relied upon.”

The economics of follow-on drug research and development

Biosimilars/Research | Posted 30/07/2009

The development of so-called ‘me-too’ or ‘follow-on’ drugs by the pharmaceutical industry has been viewed by some as duplicative and wasteful, while others have argued that these drugs often provide needed therapeutic options and inject some price competition into the marketplace.

Shifting paradigms: biopharmaceuticals versus low molecular weight drugs

Biosimilars/Research | Posted 30/07/2009

Biopharmaceuticals are pharmaceutical products consisting of (glyco)proteins. Nowadays a substantial part of the FDA-approved drugs belong to this class of drugs.

Rejected biosimilars: the Biferonex case

Biosimilars/Research | Posted 30/07/2009

On 19 February 2009, the Committee for Medicinal Products for Human Use (CHMP) of the EMEA recommended refusal of the marketing authorisation for the medicinal product Biferonex intended for the treatment of relapsing remitting multiple sclerosis. The company that applied for authorisation was BioPartners GmbH.

Rejected biosimilars: the Insulin Human Rapid Marvel case

Biosimilars/Research | Posted 30/07/2009

On 20 December 2007, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) of the EMEA that it wished to withdraw its applications for marketing authorisations for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel (active substance: insulin human), for the treatment of diabetes mellitus.

Rejected biosimilars: the Alpheon case

Biosimilars/Research | Posted 30/07/2009

On 28 June 2006 the Committee for Medicinal Products for Human Use (CHMP) of the EMEA recommended the refusal of marketing authorisation for Alpheon (interferon alfa-2a), which was intended for the treatment of adult patients with chronic hepatitis C in combination with the antiviral medicine ribavirin (except when patients could not take this).

Indian Reliance Life Sciences to launch four more biosimilars by next year

Biosimilars/News | Posted 30/07/2009

Reliance Life Sciences, based in Mumbai, India, announced on 29 March 2009 in the Indian Business Standard that it will launch four biosimilars by next year.

Indian firms may well take large slice of global biosimilars pie

Biosimilars/News | Posted 30/07/2009

Since the Indian government announced that it wants to make almost US$70 million (Euros 49.7 million) in funding available for the development of biosimilar medicines, Indian generics firms adapt their strategies and plan to go abroad. The proposed US$68 million (Euros 48.3 million) in funding just announced by India's Department of Biotechnology would be offered through the Biotech Industry Partnership Programme, with soft loans being available for biosimilar development at an interest rate of about 2%.

Third US biosimilars bill introduced: five years market exclusivity with user fee

Biosimilars/News | Posted 30/07/2009

On 26 March 2009 a third biosimilars bill was introduced in the US by Senators Chuck Schumer, Sherrod Brown, Jeanne Shaheen and Debbie Stabenow, Susan Collins, Mel Martinez and David Vitter. The bipartisan plan would give branded biologicals five years of market exclusivity, up to an additional three years to cover modifications, claiming this will give patients quicker access to cheaper drugs.

Developing biosimilars: potential risks and challenges

Biosimilars/Research | Posted 30/07/2009

Biologicals and biosimilars may often be beneficial, but sometimes new products may also give rise to some risks. Therefore it is important that clinicians familiarise themselves with the relevant literature on the safety and efficacy of these agents in various patient populations.

Key issues with biosimilars: variability problems

Biosimilars/Research | Posted 30/07/2009

Analytical studies have revealed the extent of heterogeneity of biopharmaceuticals produced by different manufacturing processes around the world. Key differences have been found in the structure, stability, composition, concentration and activity of manufactured erythropoietins (epoetins or EPOs).

Key issues with biosimilars: manufacturing impacts

Biosimilars/Research | Posted 30/07/2009

The first generation biopharmaceuticals are copies of endogenous human proteins, such as erythropoietin, insulin, growth hormones and cytokines, developed using recombinant DNA technology or hybridoma techniques. These compounds have revolutionised the treatment of many diseases, including anaemia, cancer, diabetes, hepatitis and multiple sclerosis. With expiring patents the market opens to biosimilar versions of these products.

Biosimilars: it is not as simple as cost alone

Biosimilars/Research | Posted 29/07/2009

Biosimilars or follow-on biologics (FOBs) are biopharmaceuticals that, unlike small molecule generic products, are copies of larger, much more complex proteins. As such, data generated from one biopharmaceutical cannot be extrapolated to another. Unlike small molecule generics, FOBs require a full developmental programme, albeit smaller than for an originator product. This has been recognized by European regulatory authorities and it is becoming clear that accelerated processes for FOB marketing approval are not feasible.

Biosimilars as effective and safe as expensive biologicals

Biosimilars/News | Posted 29/07/2009

Just like generic medicines, biosimilars could substantially reduce healthcare costs. Yet it seems that among physicians, pharmacists and patients there exists resistance against these cheaper versions of biotechnological medicines.

Views on biosimilars: Genentech

Biosimilars/News | Posted 29/07/2009

Genentech has put a clear position on biosimilars on its website. The company explains that the terms ‘biosimilar’ or ‘follow-on biologic’ refer to products that are marketed after expiration of patents, which are claimed to have similar properties to existing biological products. Due to the complexity of biologicals, a product can only be made that is similar, but not identical.

US biosimilars bill with competition after just five years

Biosimilars/News | Posted 29/07/2009

On 11 March 2009, Henry Waxman, Frank Pallone, Nathan Deal, and Jo Ann Emerson, all members of the US House Committee on Energy and Commerce, introduced the Promoting Innovation and Access to Life-Saving Medicine Act (bipartisan bill HR 1427), to allow the US FDA to approve affordable ‘biosimilar’ copies of biotech drugs or ‘biologicals’.

Key issues with biosimilars: impact on patient safety

Biosimilars/Research | Posted 06/07/2009

The primary safety concern for biosimilar agents is their potential immunogenicity. Using biopharmaceuticals to replace endogenous proteins that may be present at insufficient concentrations carries the serious risk of stimulating the immune system to develop anti-product antibodies (Abs), which may cross-react with endogenous protein.

What physicians need to know about biosimilars

Biosimilars/Research | Posted 06/07/2009

Physicians should become aware of potential differences between biopharmaceuticals (biologicals) and their generic versions (called biosimilars in the EU and follow-on protein products in the US) that will soon enter the market, and that the impact on safety and efficacy is critical for patient safety. “Healthcare professionals need to understand the critical issues surrounding the use of biosimilars to make informed treatment decisions”, states Professor Huub Schellekens in Biosimilar therapeutics – what do we need to consider in NDT Plus. 2009;2(Suppl 1):i27-i36.