Global Insight Perspective | |
Significance | Omnitrope has become the first biogeneric, or biosimilar, to have secured marketing approval in the United States, after a long legal tussle with the U.S. FDA. The copycat version of human growth hormone is also the first to have been approved through the so-called 505(b) 2 pathway of the Hatch-Waxman Act. |
Implications | The move is a major step forward towards clarifying the regulatory pathway for other generics of biotech medicines, according to Sandoz. The FDA, however, was at pains to stress that the approval was not precedent setting. |
Outlook | The landmark approval has once more ignited calls for specific legislation to be created for biogenerics in the U.S. Despite not opening the floodgates for other biosimilars, the move is a milestone in the future growth of Novartis’ generics unit, Sandoz. |
Precedent Setting….
Sandoz, the generics arm of Switzerland-based Novartis, revealed yesterday (31 May) that the U.S. FDA had approved human growth hormone Omnitrope as the first generic version of a previously approved biotech drug in the U.S. Omnitrope, which is a copycat version of U.S. pharmaceutical giant Pfizer’s Genotropin, is designed to treat growth disorders in children and adults.
Andreas Rummelt, CEO of Sandoz, believes the approval is ‘a major step forward in bringing needed clarity to the approval process’ for biogenerics, or biosimilars, in the U.S. market. Approval was secured by means of the so-called 505(b) 2 pathway of the Hatch-Waxman Act (under the Food Drug and Cosmetic- FD&C- Act). Omnitrope has become the first biogeneric to be approved in this fashion, Sandoz boasted..
Biosimilars should be approved and developed as soon as patent protection is lost, without specifically resorting to ‘the trade secrets and confidential information of innovators’, according to Sandoz. However, the firm shuns the ‘unnecessary duplication or unethical duplication of animal studies’ in order to avoid wasting resources.
… Or Not?
The FDA, however, was quick to point out that the green-light is not precedent-setting for other copycat biotech medicines. In Omnitrope’s case, comparisons between branded and generic versions were possible because human growth hormone is one of the better-understood proteins, the U.S. regulators pointed out. The approval ‘does not establish a pathway’ for biogenerics ‘nor does it mean that more complex and/or less well understood proteins’ approved under the FD&C act could secure approval as biosimilars, a statement on the agency’s website said.
Only a handful of biotech medicines, including growth hormone, have been previously approved as drugs, under the FD&C act, rather than biologics. Others include French drug-maker Sanofi-Aventis’ Lovenox, insulin as well as specific infertility products and enzyme-replacement treatments. However, the majority of biotech products, such as monoclonal antibodies, are licensed under the Public Health Service (PHS) Act. In this instance, there is no abbreviated approval pathway similar to 505(b) 2 for such biosimilars, the agency highlighted, before adding that such pathway would require new legislation.
Outlook and Implications
The approval has been a long time in coming, after a legal tussle with the agency over delays. Ominitrope was filed with the FDA in July 2003. Due to ‘unresolved scientific and legal issues’, the agency told Sandoz in August 2004 that it was unable to reach a verdict on the application. The delays led to the generics unit slapping a lawsuit against the FDA for failing to rule on Omnitrope. The legal battle culminated in April, with a U.S. District Court ordering the FDA to take ‘appropriate action’ because there was no ‘compelling reason’ for the delay.
The landmark approval has certainly re-kindled calls for specific scientific and regulatory pathway in the U.S. However, the decision does not open the floodgates for biogenerics in the country, judging by the U.S. regulators' comments. Nonetheless, the approval marks a milestone for the future development of Novartis’' generics unit. In fact, Sandoz believes that biogenerics are expected to play a critical role its growth strategy, as more branded biotech medicines lose patent protection in the coming years
The U.S. regulators' decision follows Omnitrope securing yet another landmark approval on April 19, this time in the European Union (EU). The biogeneric has now been rolled out in Germany, with further launches planned in other European countries later in the year. Omnitrope has also been available in Australia since November 2005, the first country to have given it marketing authorisation.
Related Articles:
- Switzerland: 16 May 2006:Sandoz Plans to Launch Up to Five New Biosimilar Medicines
- Switzerland: 4 May 2006:Novartis Launches Omnitrope at Discounted Price in Germany
- Europe: 19 April 2006: Novartis Receives European Marketing Authorisation for Biosimilar Drug
- World: 18 April 2006:FDA Ordered to Rule on Approval of First Biosimilar Drug