Biosimilars
Rejected biosimilars: the Alpheon case
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
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
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
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
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
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
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 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
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
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.
