Swiss biopharmaceutical firm Biopartners has got the thumbs up from the European Commission for its biosimilar drug Valtropin, making it only the second biogeneric drug to have been approved in Europe after Sandoz's Omnitrope received marketing authorisation last month.
Both drugs are based on somatropin, a growth hormone produced by recombinant DNA technology, and are set to compete with other products on the European market sold by Novo Nordisk, Eli Lilly, Genentech and Serono.
Some of the biggest-selling biological drugs developed during the first phase of the biotechnology revolution in the 1980s have already lost or will lose patent protection in the next few years.
With a total value of $20.2bn in global sales, insulin, human growth factor, epoetin, colony stimulating factors, interferon alpha and interferon beta are all susceptible to competition from biogenerics.
Biopartners is hoping to capture a piece of this market with Valtropin, which was developed in conjunction with Korea's LG Life Sciences.
"Valtropin is a white powder in a vial and solvent in a pre-filled syringe, which is prepared as a solution for injection," Marie-Joelle Gaufres, head of commercial operations for Biopartners, told In-PharmaTechnologist.com.
"The manufacturing of Valtropin is a multisource process and some other companies are involved in the production."
Gaufres would not name the companies involved, but firms specialising in the contract manufacture of conventional and biological active pharmaceutical ingredients (APIs) are of course monitoring developments in biogenerics with keen interest.
Biopartners is looking to have Valtropin available on the market before the end of the year and is also developing a sustained release version of Valtropin that is currently in Phase III clinical trials, as well as biogeneric versions of interferon beta, interferon alpha and epoetin.
Meanwhile Sandoz, the generic subsidiary of Novartis, is also trying to make Omnitrope available as soon as possible and will market the drug first to Germany and Austria.
The company got some good news from America last month when a federal judge ordered the US Food and Drug Administration (FDA) to decide after a long delay whether Novartis can market Omnitrope in the US.
The FDA has not yet approved any generic forms of biopharmaceuticals even though expensive biotech medicines are quickly becoming favoured treatments for a range of diseases, including cancer and arthritis.
Thus, regulatory hurdles are adding to the challenges that the sophisticated manufacturing of biogenerics pose.
The production of biogeneric APIs has to be re-developed using living cells, and so the right cell lines have to be found to produce an active ingredient that is as much as possible identical to the original supplier' s active ingredient, without infringing only one of the many application patents.
What is more, the desired active ingredient has to be obtained in a degree of purity as high as possible and in economically viable amounts.
As a result, the development of biogeneric ingredients needs financial resources much higher than those required for the development of ordinary generics, because of the complex manufacturing technology, more extensive testing and arduous approval procedures.
Nevertheless, the low sales costs associated with the targeting of clearly defined patient grounds, in combination with the high prices of biopharmaceuticals, make the pursuit of biogenetics a risk many drug firms are willing to take.
Approximately one-fourth of new drugs coming on the market are biopharmaceuticals and annual sales projected to surpass $52bn by 2010.