Are biosimilars interchangeable in Europe?
Interchangeability, switching, and substitution of a reference medicine by its biosimilar is not regulated by the EMA. These fall within the remit of European Union (EU) member states. Switching, when the prescriber decides to exchange one medicine for another medicine with the same therapeutic intent.
How many biosimilars are on the market in Europe?
In the European Union (EU), a legal framework for approving biosimilars was established in 2003 and biosimilars have been approved by the European Medicines Agency (EMA) since 2006. There are currently 69 biosimilars approved in Europe, almost all of which were marketed immediately after approval .
When was the first biosimilar approved in Europe?
The EU has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and by shaping biosimilar development globally. Since the EU approved the first biosimilar in 2006, healthcare professionals have gained increasing experience with their use.
What is a biosimilar agent?
A biosimilar is a biological product FDA-approved biosimilars have been compared to an FDA-approved biologic, known as the reference product.
What is the difference between Biosimilarity and comparability studies?
The manufacture of biologics is a complex process involving numerous steps. A comparability assessment is distinct from a biosimilarity assessment, which involves extensive assessment of a biologic that is highly similar to the originator (reference product) in terms of quality, safety, and efficacy.
What was the first biosimilar?
On March 6, 2015, the FDA approved filgrastim-sndz (Zarxio; Sandoz/Novartis), the first biosimilar ever to receive approval in the United States.
What is the meaning of biosimilars?
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company.
What is the difference between EU and FDA?
The FDA historically developed as a consumer protection agency, whereas the regulations from the European Commission arose out of a need to harmonize inter-state commercial interests while preserving national “autonomy.” Thus, whereas the FDA has the advantages of centralization and common rules, the European Union …
What is EU GMP certification?
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