Home / Biosimilars / Research

Research

What physicians need to know about biosimilars

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.

Key issues with biosimilars: impact on patient safety

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.

The economics of follow-on drug research and development

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.

The challenge of biosimilars

In a study by Professor Håkan Mellstedt of the Karolinska University Hospital Solna, Stockholm, Sweden, Professor Dietger Niederwieser of the University of Leipzig, Germany, and Heinz Ludwig of the Wilhelminenspital, Vienna, Austria – who all served as ad hoc scientific advisors to Amgen – issues associated with the introduction of alternative versions of biosimilars used in the oncology setting were reviewed.

Scientific and legal viability of follow-on protein drugs

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.

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).

Generics News Research General

more

Biosimilars News Research General

more