A bit more information, but nothing about the type/frequency of injections.
Biopartners files first biosimilar MS drug in Europe
21/08/2007 - Swiss biotech firm Biopartners has become the first company to file for approval of a biosimilar version of interferon beta-1a in the EU, laying down a challenge to rivals such as Merck Serono which sells the multiple sclerosis treatment under the Rebif brand.
Biopartners'' product, which is branded as Biferonex, is a potential competitor to Rebif, as well as other interferon-based MS treatments such as Biogen Idec's Avonex (interferon beta-1a) and Bayer Schering's Betaferon/Betaseron (interferon beta-1b).
The Swiss company is making much of the fact that Biferonex is formulated without human serum albumin (HSA) and is pH-neutral which, theoretically at least, should make it less prone to the formation of stimulating neutralising antibodies in MS patients that are known to limit the effectiveness of treatment.
Worldwide sales of Rebif reached just under €600m in the first half of 2007, with much of the growth coming from the US market, while Avonex made over $900m (€670m) in the same period. Betaferon has been under pressure form these rivals and has sales currently running at around €250m a quarter.
So should the current interferon beta group be worried about the potential threat of a lower-cost biosimilar? Not yet, according to analysts at Dresdner Kleinwort who believe the chances of Biferonex reaching the EU market remain an outside bet.
"We believe the file of generic interferon is not fully convincing," said the broker in a research note, citing the disruption caused by Biopartners' recent acquisition by Polish company Bioton for $78m earlier this year.
The analysts also believe the regulatory pathway in Europe for biosimilar interferon beta remains unclear, despite Biopartners' earlier success in bringing its biosimilar version of recombinant human growth hormone to market in Europe.
Biopartners suffered a knockback in June 2006 in its bid to bring a biosimilar version of interferon alpha, Alpheon, to the EU market after the Committee on Medicinal Products for Human Use (CHMP) decided that parts of its application dossier covering CMC (characterization, manufacturing and control) did not pass muster.
Another biolsimilar specialist, Germany's Stada gave up on its interferon beta-1a project after deciding the costs of completing the work outweighed any potential sales of the product.