BioWorld International Correspondent
BRUSSELS, Belgium - Despite some successes in the first half of 2007, the European biotech industry still has a long agenda of challenges to overcome, according to the just-released annual report of EuropaBio.
The industry association says that its advocacy work in the European Union's Brussels headquarters - which originates more than 80 percent of legislation affecting biotechnology companies in Europe, it claims has won a dramatic victory with the creation of new rules for advanced therapies, after five years of campaigning. It is also gratified by the recent easing of EU state aid rules to allow national governments to provide temporary subsidies to emerging innovative biotech companies.
But EuropaBio admits that it still needs to persuade European governments to implement the strategy agreed at the EU level for support of biotechnology, and to put into effect the more-generous new rules on state aid. Governments are also proving slow to cut administrative burdens and eliminate contradictions in issues such as clinical trials or agreements on economically viable thresholds for the adventitious presence of GM seeds in non-GM seeds. In addition, EuropaBio says it has yet to secure a real reduction of the cost of patents in Europe, and to obtain clarification of biotech patents involving stem cell research.
More Biotech Generics Approved
The top scientific committee in the European Union's medicines agency gave the green light to three more applications for similar biological medicinal products at its June 21 meeting - for presentations of epoetin alfa, based on Eprex/Erypo, the reference medicinal product already authorized in the EU by Janssen. The Committee for Medicinal Products for Human Use adopted positive opinions for Binocrit from Sandoz, Epoetin alfa Hexal from Hexal Biotech, and Abseamed from Medice Arzneimittel Pütter. All the products are intended for the treatment of anemia associated with chronic kidney disease and in oncology patients; and to reduce blood transfusion requirements in oncology patients and prior to elective orthopedic surgery. The committee found that all three products had been shown to be similar to the Janssen product in the applied indications.
TiGenix Files Cell-Based Application
TiGenix of Leuven, Belgium, filed on June 19 for European marketing approval from the European Medicines Agency for its ChondroCelect, a candidate product for the treatment of full thickness cartilage defects in the knee. The company says clinical trial data comparing the product to microfracture, the current standard of care for cartilage defects in the knee, show the formation of superior regenerated tissue. ChondroCelect is the first product for this indication that will follow the agency's centralized marketing authorization procedure as a cell therapy medicinal product. If approved, it will receive marketing authorization in all 27 EU member states as well as in Norway, Iceland and Lichtenstein. The company expects the approval process can be completed in the second half of 2008.