Amgen, Inc. (NASDAQ:AMGN) And Allergan Plc (NYSE:AGN) Herceptin Biosim Stalled By The FDA


In what has been largely termed as a major but expected drawback, Amgen, Inc. (NASDAQ:AMGN) and Allergan Plc (NYSE:AGN) were snubbed by the Food and Drug Administration on their Herceptin copycat ABP 980 biosimilar application. The move was expected by many because Pfizer and Mylan have also had their Herceptin biosims delayed. The latest events may have worked in favor of Roche’s breast cancer drug Herceptin.

What prompted FDA’s delay

In a heavily worded statement, Amgen did not reveal the issues that might have caused the delay of its Herceptin biosimilar. However, the company went ahead and said they are ready to collaborate with the FDA with the aim of ensuring that in the end patients can use the drug. The company further said the turn of event will not affect its plans to launch in the United States.

Many drugmakers have been in a rush to develop and launch their own versions of the Roche’s Herceptin, an oncology drug that has so far recorded $2.5 billion in sales in the U.S and another $7 billion in sales from the global market.

Roche’s spirited fight amid growing competition

Roche has been working hard to shed off growing competition for its Herceptin. In 2017, Roche filed a lawsuit Pfizer, a subsidiary of Dow Jones in a bid to stop it from selling its Herceptin biosimilar in the U.S. In the lawsuit, Genentech, a subsidiary of Roche said that the Herceptin biosimilar developed by Pfizer would infringe on 40 of its patents.


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Approval in Europe

Despite the setback in having the drug approved in the U.S, the duo got a boost after their biosimilars was approved in Europe. Following the approval, the companies are planning for the commercial launch of the product in markets across Europe. The drug will sell under the brand name Kanjinti. The drug is used in the treatment of early metastatic gastric cancer, metastatic breast cancer and breast cancer.Teva/Celltrion and Samsung/Biogen are some of others companies that already have their copies approved in the European market.

Amgen and Allergan secured the approval in Europe using data collected from a Phase III trial called Lilac. The trial compared the neoadjuvant paclitaxel plus ABP 980 with neoadjuvant paclitaxel plus trastuzumab. Results from the study showed that 47.8% of the women with HER2-positive early breast cancer administered with ABP 980 and 41.8% with HER2-positive early breast cancer administered with trastuzumab achieved pathologic complete response (pCR).


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