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.
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A gene therapy for multiple myeloma, a new drug for achondroplasia, and the first biosimilar version of Roche’s Lucentis are among eight products recommended for EU marketing authorization this week.
Low- and middle-income countries need to have the know-how, capability and capacity to produce mRNA vaccines, from concept, design and testing through to manufacturing and registration, a conference heard this week.
On the back of a successful pilot of early consultations with patients, the European Medicines Agency is extending the initiative so that patient and health care professional groups can give valuable input in areas such as unmet needs, clinical trial endpoints and expectations for future treatments.