Biosimilars

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.