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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New EU guidance will cover non-clinical and clinical development, trial design, endpoints, safety issues and comparators, as well as the use of immunobridging studies.
The new committee, which will initially be in place for a year, will advise the French drug regulator when it is preparing its opinions on substitution in specific biosimilar product groups.
The TGA has taken a series of actions to address supply chain issues, including on the regulatory front, but it says more remains to be done and is asking stakeholders for suggestions in a new online survey.