Pfizer Is King Of The US Biosimilar Hill
Four biosimilar candidates are under US FDA review, including what could be Pfizer’s eighth biologic approved under FDA’s 351(k) biologics license application pathway.
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Agency approved 11 biosimilars from six sponsors with only one publicly disclosed complete response letter (Tanvex’s filgrastim). Pink Sheet infographic shows 351(k) application submission, approval and CRL rates over the life of the user fee program.
Gene therapy and lambda interferon products are highlighted in the new Review Pathways section of the US FDA Performance Tracker, which keeps track of breakthrough therapy (BTD), regenerative medicine advanced therapy (RMAT), qualified infectious disease product (QIDP) designations and biosimilar submissions.
Celltrion has begun a Phase III study with a subcutaneous version of its infliximab biosimilar in the US, after the FDA allowed it to skip Phase I and II trials based on approval data in Europe, enabling a lower development time and cost.