Sector News

Amgen, Allergan’s Herceptin biosimilar filed in the US

August 2, 2017
Life sciences

US biotech giant Amgen and Dublin, Ireland-based Allergan have now filed ABP 980 – a biosimilar version of Roche’s blockbuster biologic trastuzumab – with the US Food and Drug Administration.

In the US, trastuzumab is approved under the brand name Herceptin for the treatment of HER2-positive adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer.

The active ingredient of ABP 980 is a humanised monoclonal antibody that has the same amino acid sequence as trastuzumab; the drug’s submission includes data showing comparable efficacy, safety and immunogenicity in adult female patients with breast cancer.

Herceptin currently pulls in nearly $7 billion a year in sales.

“Approval of ABP 980 would provide more patients access to a high-quality therapy with a proven safety and efficacy profile,” said Sean E Harper, MD, executive vice president of Research and Development at Amgen. “We look forward to further discussions with the FDA.”

Amgen and Allergan are working together on the development and commercialisation of four oncology biosimilars under a deal signed in 2011; ABP 980 was also filed in Europe earlier this year.

By Selina McKee

Source: Pharmatimes

comments closed

Related News

May 21, 2022

As monkeypox cases emerge in US and Europe, Bavarian Nordic inks vaccine order

Life sciences

A monkeypox outbreak is emerging in the U.S. and Europe, and at least one country is amping up countermeasure preparedness. Bavarian Nordic has secured a contract with an unnamed European country to supply its smallpox vaccine, called Imvanex in Europe, in response to the emergence of monkeypox cases, the Danish company said Thursday.

May 21, 2022

Moderna chairman Afeyan defends hiring practices after CFO debacle: report

Life sciences

Moderna’s recent chief financial officer debacle—in which Jorge Gomez departed on his second day on the job—raised questions about the company’s hiring process given its rush to global biopharma prominence. The most obvious one: How was it possible for Gomez to be hired when he was under investigation by his previous employer, Dentsply Sirona of Charlotte, N.C.

May 21, 2022

Merck to pay up to $1.4B in cancer deal with Kelun, but details are scarce

Life sciences

Merck & Co. is plucking a cancer project from the branch of Chinese-based Kelun Pharmaceutical for up to $1.4 billion, but details from the New Jersey-based Big Pharma have been hard to come by. The deal, first disclosed Monday on the Shenzhen stock exchange, has Merck handing over $47 million in upfront cash in exchange for ex-China rights to a “macromolecular tumor project.”