Biosimilar insulins and analogs set to erode $6.1 billion in brand sales in the USA and Europe by 2018

Biosimilar insulins and insulin analogs stand to erode $6.1 billion in brand sales in the USA and Europe (France, Germany, Italy, Spain and the UK) by 2018, saving health care systems $3.8 billion in the process, according to a new report from research and advisory firm Decision Resources. 'Biosimilars' are copies of original drugs generated through bioengineering but, unlike the typical generic, are not deemed to be completely bioequivalent.

As insulins are relatively easy to develop and manufacture, the new special report entitled Biosimilars: ESAs, Insulins and Human Growth Hormones, predicts that a number of competing long-acting biosimilar insulins, which are typically injected once or twice daily, will enter the market during the 2008-2018 study period. Based on differences in revenue and upon patent expiry, Sanofi-Aventis' Lantus presents a greater opportunity for manufacturers of biosimilars than Novo-Nordisk's Levemir, the report notes.

"Our survey data suggests that most endocrinologists expect to begin prescribing biosimilars within a year after they launch. Although endocrinologists will require a fair amount of clinical data before they will be comfortable prescribing biosimilars, they have fewer reservations about using biosimilar insulins (used in patients with diabetes) than they do for biosimilar human growth hormones (used in patients with human growth hormone deficiency)," stated MaryEllen Klusacek, analyst at Decision Resources.

The report also finds that although surveyed nephrologists have an overall conservative attitude towards biosimilar use, they are not completely opposed to prescribing a copy product for an indication in which it has been approved, but not clinically studied. Based on European Medicines Agency (EMEA) guidelines and proposed legislation in the USA, biosimilars will be labeled for each indication for which the reference product is labeled, even if the product is only clinically studied in one indication. For example, while Johnson & Johnson's Procrit/Eprex is approved for and used in the treatment of chronic renal failure and chemotherapy induced anemia, its biosimilar may only be studied in chemotherapy induced anemia, yet get approved for all of the indications that have been cleared forProcrit/Eprex.

"In order to head off competition from biosimilars that need additional validation, makers of branded biologics should create marketing campaigns focusing on their agents' proven safety and efficacy," added Dr Klusacek.

Diabetes care shifting to earlier, expanded insulin use, Scientia Advisors finds

Meantime, a new study released by management consultancy Scientia Advisors, finds that diabetes care is undergoing a paradigm shift in which insulin is being prescribed earlier, for more conditions, in order to delay the onset of full-blown disease. In light of that trend, as more drugs become generically available, companies offering newer, more expensive drugs will face resistance in markets most constrained by economics.

In the words of Harry Glorikian, Scientia Advisors' managing partner: 'While there are exciting developments in the non-insulin oral drug categories, the makers of these newer medications would be wise to stay attuned to how to best position their products - specially when marketing in emerging economies, which are extremely sensitive to costs.'

According to Mr Glorikian: 'We expect that as more drugs are available in generic form, incretin mimetics (which increase insulin secretion) and insulins will generate an increasing share of the revenues. Therapies with benefits beyond glucose management (such as delaying the onset of diabetes or treating co-morbid conditions) will be used earlier in treatment. For a variety of reasons, despite the growing availability of new types of drugs, various forms of insulin will remain the gold standard.'