EMA draft guidance points out challenges to biosimilar interferon beta developers
This article was originally published in SRA
Executive Summary
The European Medicines Agency has issued a draft guideline for companies wanting to develop biosimilar versions of interferon beta for the treatment of multiple sclerosis1,2. 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.
You may also be interested in...
UK Spending £2.9bn On Seven COVID-19 Vaccines
The UK government says it is on track to vaccinate the 15 million most vulnerable people by mid-February, and that a “major study” is under way to assess the potential impact of the new UK variant on vaccine efficacy.
Coronavirus Notebook: EU To Buy 30 Million Doses Of Valneva Vaccine, Russia To Issue Compulsory License For Remdesivir
The European Medicines Agency says hacked COVID-19 vaccine data has been leaked online, and Australia’s chief medical officer defends the Oxford/AstraZeneca vaccine against scientists’ claim that it is not effective enough.
EU Biosimilar Filings, Opinions And Approvals
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: