'Uncomfortable' Panel Backs Amgen Biosimilar, But Uphill Battle To Sway Docs, Public
A tense advisory committee meeting, where many of the panelists admitted they lacked a complete understanding about biosimilars and patient advocates expressed anxiety over the products, could signal difficulties with adoption and success in the marketplace.
You may also be interested in...
With the FDA giving an overwhelmingly positive review of Sandoz Inc.'s application for its biosimilar version of Enbrel (etanercept), which is sold in the US by Amgen Inc., the product appears to be headed to the US market – pending a likely blessing from the agency's advisory panel, which is meeting on July 13. But Sandoz must still get past litigation and convince prescribers and patients its etanercept biosimilar provides value over Enbrel.
Amgen Inc. appears to have a smooth path to FDA approval of its biosimilar of AbbVie Inc.'s tumor necrosis factor Humira (adalimumab) based on documents released ahead of a July 12 advisory committee meeting. But don't expect AbbVie to just sit back and take it.
Amgen Inc. revealed on Jan. 25 the FDA had accepted the firm's 351(k) application for its biosimilar of AbbVie Inc.'s tumor necrosis factor blocker Humira (adalimumab).