Pliva gets first approval for generic EPO

The company, which recently exited the proprietary drugs market to focus exclusively on the generics and active pharmaceutical ingredients (API) sector, 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.

Pliva has staked a claim to the new territory through product development agreements with Barr Laboratories and Mayne Pharma.

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. 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.

Nevertheless, Zeljko Covic, Pliva's CEO, said that the registration of EPO in Croatia is a milestone for the company as it 'demonstrates the quality and capabilities of our project team'.

"We believe that this achievement clearly shows that Pliva will be among the very few companies that will succeed in both developing and registering biogenerics across global markets while respecting developing regulatory rules and patent protection for these markets,"​ he said in a statement.

Branded biological drugs generated an estimated total of $32 billion (€26bn) in sales for the biotechnology and pharmaceutical industries in 2003 and represented the fastest-growing group of medicines - but by 2010, when the market is forecast to be worth $53bn, biologicals which accrue an estimated $11bn worth of sales annually are expected to have lost patent protection in developed pharmaceutical markets.

The high cost of biologics (often tens of thousands of euros per patient a year) lends some urgency to the approval of biogenerics for healthcare budgeters.

EPO, first introduced in 1988, is a multibillion dollar drug primarily indicated for the stimulation of red blood cell production in patients undergoing dialysis therapy for chronic renal failure and patients undergoing chemotherapy treatment.