Now that Sandoz, the generic unit of Novartis, has won European Commission backing to launch the first biosimilar EPO drug, Johnson & Johnson is worrying aloud over patient safety. The EC's decision follows a recommendation from a European Medicines Agency committee in June, which found that the follow-on biologic is similar to J&J's Eprex (which is known as Procrit in the US).
Sandoz spokesperson Kurt Leidner tells BiopharmaReporter.com that the newly approved biosimilar will hit the EU market within two months, starting with Germany. And it will cost up to 30 percent less than the J&J drug, depending on the country. "However, the price has not yet been determined," he says.
J&J's Janssen-Cilag unit says it "supports the goal of increasing access to affordable biologics that are safe and effective for patients while maintaining essential incentives for innovation." But a company spokesperson adds J&J is "very concerned that allowing biosimilar products to have the same international non-proprietary name (INN) as the reference product will present considerable safety issues for patients. Our hope is that the EU will continue to be guided by the premise that patient safety must be assured."
The subject of INN for biologics has been a great concern for the biopharma industry which has been calling EU regulators for clarification. Under the current World Health Organisation's (WHO) drug naming system, each therapeutic compound is assigned an INN so that each would be recognised globally by a unique name, facilitating the identification of pharmaceutical substances and active pharmaceutical ingredients.
In addition, INNs are also assigned to biologics, which are more difficult to deal with due to their complexity, according to the WHO. As a result, the WHO last November said it was time to update the INN system and adapt its nomenclature for biologicals to reflect how science has evolved during the last five years, in particular with the arrival of biosimilars in the pharmaceutical landscape.
But until then, Janssen-Cilag has all the reasons to be worried for the future of Eprex, in particular as far as sales are concerned. The drug generated over $1.1bn in Europe and Canada last year although the firm does not disclose a breakdown of the drug sales in Europe. J&J's spokesperson says the health care giant was anticipating the influx of biosimilars onto the market for a while, however, but won't speculate on how big the impact of Sandoz' new product will have on future sales of Eprex.