Swiss biopharmaceuticals company Biopartners has received authorization to market its recombinant growth hormone Valtropin in the European Union (EU), the company reported.
It is only the second biosimilar product the European Commission (EC) has approved for marketing in the EU. The EC approved Sandoz' recombinant human growth hormone Omnitrope (somatropin recombinant) in April.
Valtropin (somatropin recombinant) is designed to treat Turner's Syndrome and human growth deficiency in children. Common symptoms of Turner's Syndrome -- which only affects girls -- include short stature and undeveloped ovaries.
The EC decided to grant marketing authorization for Omnitrope and Valtropin after the European Medicines Agency's Committee on Medicinal Products for Human Use recommended approval of the products.
The U.S. FDA has not approved any biosimilar products, but Omnitrope may be one step closer to entering the U.S. market after a federal district court ordered the FDA to either approve or reject Sandoz' application to market the product. Judge Ricardo Urbina of the U.S. District Court for the District of Columbia called the agency's nearly 1,000-day review of Omnitrope "unreasonable" in light of the 180-day review deadline mandated by statute.
Sandoz sued the FDA in 2005, accusing the agency of unlawfully delaying a decision on the firm's application to market generic human growth hormone.