Biosimilars
Biosimilars and biopharmaceuticals: the ERA-EDTA position
In a position paper by the European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Council in Nephrology Dialysis Transplantation written by Adrian Covic of the Parhon University Hospital in Iasi, Romania – who received financial gratitude for congress participation, lectures and clinical trials from: Amgen, Affimax, F. Hoffmann-La Roche and Janssen-Cilag – and co-authors, it is stated that biosimilars may offer considerable advantages to hard-pressed healthcare economies, as the costs of providing effective therapies in a variety of new and existing disease areas increase progressively. However, a decision to permit their use clinically should be balanced by a clear mandate to ensure as with all biopharmaceutical agents, that patients, physicians and pharmacists truly understand the complex arguments and decisions which apply to this new and challenging area. In particular, pharmacovigilance is a responsibility that is shared between the pharmaceutical industry, pharmacists and physicians, with appropriately informed and educated patients. Ease of tracing and identification of new/substituted agents especially when dealing with patients who may be exposed to injected therapies for many years is a pivotal requirement and one where new input into nomenclature decisions and systems is now urgently needed. Any decision to employ biosimilar biopharmaceuticals should be taken with appropriate knowledge and understanding of this complex area by the primary responsible physician, after a careful appraisal of the advantages and disadvantages of taking this course of action, and with appropriate systems for pharmacovigilance in place.
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.
Economic issues with follow-on protein products
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
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
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
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.
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).
