Seeking approval for generic interferon in Europe

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Seeking approval for generic interferon in Europe

Postby dignan » Mon Aug 20, 2007 9:42 am

This is a surprise. It looks like a generic version of rebif/avonex has been submitted for approval in Europe. I hope this marks the start of price reductions in MS drug prices.



Biopartners Submits Its Novel Interferon beta-1a, Biferonex®, To The EMEA

BAAR, Switzerland--(BUSINESS WIRE)--Biopartners Holdings AG today announced that it has submitted a marketing authorization application for Biferonex® (interferon beta-1a) to the EMEA. Biferonex represents a fully innovative, pH neutral and human serum albumin (HSA) free formulation providing an optimized interferon beta treatment solution for patients suffering from relapsing remitting multiple sclerosis (RRMS).

The submission was welcomed by Professor O. R. Hommes, Chairman of the European Charcot Foundation which coordinates MS research in Europe. “Most impressive are the effects of Biferonex in reducing the size and the activity of inflammatory regions in the brain of MS patients as shown by MRI. This may reduce progression of the disease” he stated.

Interferon beta has been extensively studied in multiple sclerosis, exhibiting beneficial effects in both the relapsing-remitting and progressive forms of the disease by inhibiting inflammatory activity and thereby reducing nerve cell damage. It is also thought to inhibit damage to the myelin sheath by both preventing a T cell-mediated auto-immune response to myelin, and reducing the effect of other naturally-occurring compounds that can enhance the auto-immune response.

The Biferonex HSA-free formulation boasts a low incidence of neutralizing antibodies (NABs) therefore optimizing drug treatment effectiveness. Additionally, its neutral pH minimizes the risk of injection site reactions, which should lead to an enhanced tolerability.

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Last edited by dignan on Mon Aug 20, 2007 11:57 am, edited 1 time in total.
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Postby gwa » Mon Aug 20, 2007 10:27 am

I had wondered why there were not any generics for the CRABS since they have been around for years.

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Postby ewizabeth » Mon Aug 20, 2007 10:56 am

Dignan,

Is this the high dose 3x weekly like Rebif?

If so, and if it's cheap enough, this will be a blessing for those without insurance and/or RX coverage. Even for those with high formulary charges...

Thanks for posting this, I hope it passes and the US follows suit afterward. :)
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby dignan » Mon Aug 20, 2007 12:09 pm

Ewizabeth, I don't know if it's 3x per week subcutaneous or 1x per week intramuscular. I couldn't find any info on that.
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Postby dignan » Tue Aug 21, 2007 9:27 am

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.

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