Biosimilars, FDA

FDA stalls yet another Herceptin copycat, issuing response letter to Amgen/Allergan

In a somewhat unsurprising setback, Amgen $AMGN and its partner Allergan got snubbed by the FDA Friday on the duo’s biosimilar application for their Herceptin copycat ABP 980. Expected only because the FDA has already delayed two other Herceptin biosims from Mylan and Pfizer.

Just days ago, Amgen/Allergan’s drug ABP 980 got approval from regulators in Europe, where it can now sell under the brand name Kanjinti. The drug can be used to treat early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

The companies got that OK using data from a Phase III trial called Lilac, comparing neoadjuvant paclitaxel plus ABP 980 with neoadjuvant paclitaxel plus trastuzumab. Findings from that trial showed that in women with HER2-positive early breast cancer, 47.8% of patients in the ABP 980 arm and 41.8% in trastuzumab arm achieved pathologic complete response (pCR).

Both Mylan and Pfizer were also able to score OKs in Europe for their Herceptin biosims, and eventually Mylan even got an FDA OK for Ogivri (after a 3-month delay).

Amgen and Allergan filed their application in the US back in August 2017, hoping — like many others in the industry — to take a slice of Roche’s sales (which brought in $7 billion globally last year).

Approval for this drug in the US would create competition both for Herceptin and for other biosims lining up to cut into the market, including Ogivri, approved by the FDA last December. But apparently its no dice, for now.

It’s not clear yet what the FDA took objection to. In Amgen’s brief (very brief) statement, it said the company had plans to work closely with the FDA on the product and that it did not expect the CRL to impact its US launch plans.


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