Biosimilars
BIO wants to delay biodissimilars as long as possible
Biotech drugs are big revenue earners. Their sales growth rate may have slipped back into single figures last year, but according to IMS Health data they still accounted for more than 37% of the growth in the US pharmaceutical market last year, with revenues of around US$85 billion (Euros 60.8 billion), and biotech stands to take an even larger share of the market in future.
Obama wants to introduce US biosimilars pathway
US President Barack Obama plans to fund part of his healthcare reform plans by backing an approval pathway for generic biologicals. As reported by Christopher Spillane in Scrip News, Mr Obama lobbied the American Medical Association to support proposals to overhaul US healthcare in a far-reaching address.
US Federal Trade Commission issues report on biosimilars
The US Federal Trade Commission (FTC) released a report entitled Follow-on Biologic Drug Competition, which examines whether the price of biological drugs could be reduced by competition from so-called ‘follow-on biologics’ (FOBs) or biosimilars.
New expression systems create competitive advantage
New, alternative expression systems in various stages of development are showing their viability in large-scale protein manufacture. The economics and increased simplicity of these new platforms make them better alternatives to the currently dominant E. coli, yeast and CHO systems.
High yields and human-like glycosylation with DSM’s technology
DSM says that studies done at its R & D laboratories in Groningen, The Netherlands, show that its extreme density (XD) technology boosts bioreactor productivity and titers of mammalian cell culture processes for protein and antibody production. The studies show that the yields from Chinese hamster ovary cell cultures can be increased 5-10 fold over their previous fed-batch processes using only off the shelf, commercially available media.
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.”
