Seeking approval for generic interferon in Europe
Posted: Mon Aug 20, 2007 8:42 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.
Link
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.
Link