A panel for European regulators has recommended approval of three biogeneric versions of Johnson & Johnson's anaemia drug Eprex.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given its backing to two biosimilars made by Novartis’ Sandoz (Binocrit) and one by Hexal (Epoetin alfa Hexal) and Medice Arzneimittel Puetter (Abseamed), which are generic versions of J&J’s Eprex/Erypo (epoetin alfa). The latter, which lost its patent protection in Europe last year. treats anaemia in patients with chronic kidney disease and cancer and a final decision on the generic versions by the European Commission is expected to make a final decision in the next 60 to 70 days.
Sandoz noted that more than 250,000 patients in Europe are estimated to be treated with epoetin alfa, and sales in the continent are estimated at more than $600 million. This is the second time that the CHMP has issued a positive opinion for a Sandoz biosimilar after its “precedent-setting decision” in April last year to approve Omnitrope, a copycat version of Pfizer's Genotropin (somatropin).
Sandoz chief executive Andreas Rummelt said that receiving European approval for this medicine “ will improve access for patients and also contribute significant savings to healthcare budgets,” adding that “we are committed to further developing these types of medicines and have several projects in the pipeline”.
The recommendation highlights the differences highlights the difference between the USA and Europe when it comes to approving generic versions of biologics. There are moves going on across the Atlantic which are looking at the process of developing a framework for approving biosimilars but there is an argument that generic biologics need far more rigorous testing in order to ensure safety.
However J&J seems happy with the law in Europe and said it “supports the goal of increasing access to affordable biologics that are safe and effective for patients while maintaining essential incentives for innovation". The company added that the
EU “has made substantial progress in developing and implementing a policy for the approval of biosimilar medications that is grounded in good science and public health”.