Biosimilares

Economic issues with follow-on protein products

Biosimilares/Investigación | Posted 30/07/2009

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.

Scientific and legal viability of follow-on protein drugs

Biosimilares/Investigación | Posted 05/08/2009

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.

The challenge of biosimilars

Biosimilares/Investigación | Posted 05/08/2009

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.

Biosimilars and biopharmaceuticals: the ERA-EDTA position

Biosimilares/Investigación | Posted 05/08/2009

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.

High yields and human-like glycosylation with DSM’s technology

Biosimilares/Novedades | Posted 05/08/2009

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.

New expression systems create competitive advantage

Biosimilares/Novedades | Posted 05/08/2009

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.

US Federal Trade Commission issues report on biosimilars

Biosimilares/Novedades | Posted 05/08/2009

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.

Obama wants to introduce US biosimilars pathway

Biosimilares/Novedades | Posted 31/08/2009

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.

BIO wants to delay biodissimilars as long as possible

Biosimilares/Novedades | Posted 31/08/2009

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.

KBI BioPharma starts US PER.C6 cell line generation service

Biosimilares/Novedades | Posted 04/09/2009

US contract services firm KBI Biopharma announced on 25 June 2009 that it has started using the PER.C6 platform for cell line generation as part of its offering to meet growing demand for biomanufacturing services, whether they are to produce biologicals, biosimilars or vaccines.