BioWorld International Correspondent
Sandoz GmbH plans to launch Europe's first biogeneric drug, Omnitrope (somatropin), within a matter of days, following the European Commission's decision Tuesday to grant a marketing authorization for the recombinant human growth hormone.
Company Spokesman Kurt Leidner told BioWorld International that Sandoz will market the product in Germany and Austria initially. Further launches in the European Union's 25 member states will follow reimbursement negotiations with the states' respective national health care systems.
The Holzkirchen, Germany-based company, a subsidiary of Basel, Switzerland-based Novartis AG, has not disclosed pricing for the product, but Leidner said it sells at a 25 percent discount to its reference product, Genotropin, in Australia, where it was launched in November. The average price for recombinant human growth hormone in Europe is about €11,000 (US$13,500) at present, he added, and the addressable market comprises around 50,000 patients.
Omnitrope's route to market has been eventful because of the regulatory uncertainty surrounding follow-on versions of biologic drugs. Sandoz has filed lawsuits against the European Commission and the FDA, both of which are ongoing.
April 10, the company obtained a summary judgment in the U.S. District Court for the District of Columbia, which requires the FDA to act on its original regulatory filing of July 2003. It still remains unclear, however, when - or if - the product will gain U.S. approval.
"The judge didn't give an indication as to what the appropriate time frame would be," Leidner said.
Analyst Denise Anderson at Kepler Equities in Zurich, Switzerland, said that Omnitrope is not likely to attain blockbuster status.
"It's already quite a fragmented market," she said. "It's not going to make or break Novartis." Nevertheless, in a research note published April 7, she wrote that biogeneric drugs have the potential to "transform" the drug industry in the medium term.
The formal approval by the European Commission of a second biogeneric is expected next month. BioPartners GmbH, of Baar, Switzerland, received a positive recommendation in February for Valtropin (somatropin), based on Humatrope, marketed by Eli Lilly and Co., of Indianapolis. Company officials were unavailable for comment.