A European regulatory committee has recommended the approval of three generic versions of Johnson & Johnson's (J&J) anaemia blockbuster Eprex in what could lead to the market launch of new "biosimilars" by the end of the year.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) said the three follow-on biologic drugs have been shown to be similar to Eprex, which is marketed as Procrit in the US by Ortho Biotech Products, a J&J subsidiary.
The three biosimilars - Binocrit developed by Sandoz, Epoetin alfa Hexal, from Hexal Biotech and Abseamed from Medice Arzneimittel Pütter - belong to the epoetin alfa class, which is based on the human protein erythropoietin (EPO) and used to treat anaemia associated with kidney disease and cancer therapy.
Sandoz and Hexal are both subsidiaries of Swiss drug maker Novartis, while Medice Arzneimittel Pütter is a Sandoz licensing partner, Kurt Leidner, spokesperson for Sandoz, told BioPharma-Reporter.com.
The European Commission usually follows the CHMP's recommendations and should release a formal decision in about two months.
"We are waiting for the marketing authorisation which usually takes 67 days to be issued by the EMEA; if we get it, we expect to launch the products by the end of the year," said Leidner.
If Biocrit gains approval it will be Sandoz' second biosimilar marketed in EU. The biotech company was the first to launch a generic biologic last April, the human growth hormone Omnitrope, while US approval was granted in May 2006.
The firm has been focusing on biogenerics and as more biopharmaceuticals lose patent protection in the coming years, these products are expected to play a key role in the growth strategy of Sandoz, the company said.
Leidner said the market for epotein alfa drugs represents $7bn (€5.2bn) globally, of which $600m are generated in Europe.
Although Eprex's patent has expired in most major European markets, an erythropoietin biosimilar has not yet been approved.
For J&J, the launch of three similar versions of the drug could seriously hit revenues which, combined with sales of Procrit, amounted to $3.2bn worldwide last year. J&J does not disclose a breakdown of Eprex's sales in Europe.
Commenting on the CMPH's positive review, a J&J spokesperson said in an email: "While we have not had the opportunity to fully review the CHMP opinions rendered on three biosimilar epoetin alfa products, our hope is that these opinions are in line with the EU policy and are based on the premise that patient safety must be assured."
"Johnson & Johnson supports the goal of increasing access to affordable biologics that are safe and effective for patients while maintaining essential incentives for innovation," said the firm.
However, the company refused to comment on the impact the launch of three generic versions of Eprex will have on sales.