Biosimilars/Research
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.
Shifting paradigms: biopharmaceuticals versus low molecular weight drugs
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
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
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.
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.
