1. Scrip
  2. >>Therapy Areas
  3. >>Neurological

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

Novartis Signs Up For BioArctic Blood-Brain Barrier Tech

 
• By Kevin Grogan

The Swiss giant is paying $30m upfront for rights to the Swedish firm’s BrainTransporter technology, its second brain-barrier breaching deal in as many months.

AbbVie Buys Phase II MDD Candidate From Gilgamesh, But Not The Company

 
• By Joseph Haas

Partnered since May 2024, AbbVie and Gilgamesh agreed on a deal in which AbbVie will buy bretisilocin for up to $1.2bn, while Gilgamesh will spin out its remaining pipeline.

Interest In PTC’s Sephience Launch Overshadows FDA’s Vatiquinone Rejection

 
• By Alaric DeArment

PTC said it got a complete response letter for the Friedreich’s ataxia drug, with the agency asking for an additional clinical trial.

Post-GLP-1 Patients Are Significant Opportunity, But Response Sees More

 
• By Alaric DeArment

The company will move ahead in testing RDX-002 among overweight and obese patients coming off GLP-1s, but the CEO said antipsychotic-induced weight gain could represent a multibillion-dollar market.

More from Therapeutic Category

In Brief: Bavarian Nordic’s Board Votes For Private Equity Takeout

 
• By Joseph Haas

The Danish firm’s board unanimously supports a $2bn take-private offer by PE firms Nordic Capital and Permira. A revised offer would seek to bypass the opposition of a major shareholder.

Regeneron Plans To File Cemdisiran For gMG But Will Face Tough Market

 
• By Jessica Merrill

Head of hematology clinical development Andres Sirulnik talked to Scrip about the positive Phase III results for the siRNA medicine.

Novartis Signs Up For BioArctic Blood-Brain Barrier Tech

 
• By Kevin Grogan

The Swiss giant is paying $30m upfront for rights to the Swedish firm’s BrainTransporter technology, its second brain-barrier breaching deal in as many months.