Pliva gets first approval for biosimilar medicinal product (EPO)

Croatian pharmaceutical company Pliva has won its first European approval for generic erythropoietin, a biologic drug used for the treatment of low red blood cell counts.

Pliva said its EPO is a generic version of Johnson & Johnson subsidiary Janssen Cilag’s Eprex (epoetin alfa). The approval, in its home market of Croatia, is the first for the product.

Pliva is one of a growing number of companies seeking to carve out a business in the so-called biogeneric sector, which has yet to take off in the US and Europe despite the expiry of patents on a number of the first wave of protein-based drugs launched in the late 1980s and early 1990s.

The problem for regulators is that, given the complex, biological nature of protein drug production, it has been difficult to establish a set of criteria to show that a biogeneric is indeed equivalent to its branded counterpart. Advances have been made in the European Union with the drawing up of a system for ‘biosimilar’ drugs, while similar moves are underway in the US, where biogenerics are known as ‘follow-on biologics’. However, there is still much political work to be done, and to date no generic biologic drug has been approved in these territories.

Croatia lies outside the EU at the moment, so Pliva’s approval for EPO there does not represent a test of the EU’s framework for biosimilar approvals. Croatia has started the process of accession to EU and it is expected that Croatia could become member state if EU within next few years.

This test is being supplied by Switzerland-based BioPartners. BioPartners and Sandoz have both filed applications to market biomilar versions of human growth hormone in the EU, but while the former dossier is still active, Sandoz offering was turned down on procedural grounds. BioPartners has also filed for approval of a generic version of interferon alpha for hepatitis C.

• Jacobsen Pharma A/S (20/07/2010)
• Pharma Marketing 2010 (20/07/2010)
• Achieving preferential patient-access through innovative agreements with payers (09/07/2010)

• DMF project (03/01/2006)
• Data Exclusivity (29/12/2005)
• New CADREAC (16/12/2005)

---