Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. The European ...

To date, EMA has recommended the approval of 106 biosimilars within the product classes of: 1) human growth hormone; 2) granulocyte colony-stimulating factor; ...

The European Medicines Agency (EMA) is responsible for evaluating the majority of applications to market biosimilar medicines before they can be approved and ... Eligibility and reference product · Post-authorisation

Ten biosimilars received EMA approval first, with a median time of 18 months to FDA approval (interquartile range (IQR), 6–63 months). Five of these biosimilars ...

For each medicine approved through EMA, including biosimilars, EMA publishes a group of documents known as the european public assessment report. ('EPAR').

Biosimilar medicines are approved by the. European Commission (EC) through the. European centralised procedure, which is overseen by the European Medicines.

Four more biosimilars were approved in 2018 and 2019; Herzuma (Celltrion), Ontruzant (Samsung Bioepis), Trazimera (Pfizer) and Kanjinti (Amgen) (33) .

19 сент. 2022 г. · Biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.

31 окт. 2019 г. · Biosimilars can only be authorised once the period of data exclusivity on the reference biological medicine has expired.

24 сент. 2024 г. · The three approved biosimilars are Reddy Holding's Ituxredi (rituximab), Midas Pharma's Ranibizumab Midas (ranibizumab), and Prestige Biopharma's Tuznue ( ...