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EMA guidance points up challenges to biosimilar interferon beta developers

 
• By Ian Schofield

The European Medicines Agency has issued a draft guideline for companies wanting to develop biosimilar versions of interferon beta for the treatment of multiple sclerosis. As with all biosimilars, there will be a number of challenges for developers of interferon beta, not least the complexity of the disease and the substance, safety issues, and differences among the available reference products.

The European Medicines Agency has issued a draft guideline for companies wanting to develop biosimilar versions of interferon beta for the treatment of multiple sclerosis. As with all biosimilars, there will be a number of challenges for developers of interferon beta, not least the complexity of the disease and the substance, safety issues, and differences among the available reference products.

Recombinant interferon beta is currently the mainstay of disease-modifying therapies in MS, which is one of the most common causes...

More from Neurological

Biogen’s Spinraza Follow-On May Offer Disease-Modifying Potential

 
• By Joseph Haas

Biogen hopes to move directly from Phase I to Phase III with salanersen, a higher-potency therapy that uses the same mechanism of action as Spinraza.

Skyhawk Looks To Soar With Huntington’s Hope

 
• By Kevin Grogan

Oral RNA splicing modulator has gone into a Phase II/III trial

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By Kevin Grogan

Wales-based group launches with $140m series A.

Supernus Secures Sage With CVR-Supported Deal

 
• By Jessica Merrill

Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.

More from Therapeutic Category

BerGenBio Plumps For Oncoinvent From Long List Of 50 Suitors

 
• By Kevin Grogan

The merger with a fellow Norwegian biotech comes a few months after its lead asset, bemcentinib, bit the dust.

In Brief: Opus Gears Up For FDA Filing In Presbyopia

 
• By Sushmita Panda

Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.

Protagonist Hopes To Come From Behind In Obesity With Oral Triple Agonist

 
• By Jessica Merrill

The company announced plans to move an oral GLP-1/GIP/GCG receptor agonist peptide into clinical development for obesity in 2026.