The EC's decision to grant this approval follows a recommendation from a European Medicines Agency (EMEA) committee in June, which found that the follow-on biologic drug has shown to be similar to Johnson & Johnson's blockbuster Eprex (epoetin alfa).
Eprex is manufactured by Ortho Biologics and sold by Janssen-Cilag (both J&J subsidiaries).
The drug is sold almost exclusively to the European and Canadian markets and is marketed under the sub-brands Erypo, Epopen, Epoxitin, and Gluburen.
This approval was indicated for the use of biosimilar epoetin alfa in treating patients with renal anaemia as well as those receiving chemotherapy.
Sandoz spokesperson Kurt Leidner told Biopharma-Reporter.com that the newly approved biosimilar will hit the EU market within two months, starting with Germany.
It will be marketed by Sandoz as Binocrit and as Epoetin alfa Hexal by Hexal Biotech - another Novartis subsidiary - "depending on the countries".
Medice Arzneimittel Putter, a Sandoz licensing partner, has also the permission to sell the product as Abseamed.
Leidner said Binocrit/Hexal will cost around 25-30 per cent less than the reference product depending on the countries, as Eprex is not priced the same everywhere.
"However, the price has not yet been determined," said Leidner.
Responding to the news, Janssen-Cilag told Biopharma-Reporter.com that it "supports the goal of increasing access to affordable biologics that are safe and effective for patients while maintaining essential incentives for innovation."
However, a company spokesperson said in an email that the firm 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," he added.
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 said his company has been anticipating the influx of biosimilars onto the market for a while, however, he refused to speculate on how big the impact of Sandoz' new product will have on future sales of Eprex.