Dr. Kolberg Discusses Next Steps with ABP 980

Hans-Christian Kolberg, MD
Published: Thursday, Aug 16, 2018



Hans-Christian Kolberg, MD, head, Department of Obstetrics and Gynecology, Breast Cancer Center, and Gynecologic Cancer Center at Marienhospital Bottrop, Klinik für Gynäkologie und Geburtshilfe, Bottrop, Germany, discusses next steps with the trastuzumab (Herceptin) biosimilar ABP 980.

The phase III LILAC study showed an equivalent pathologic complete response (pCR) rate between trastuzumab and ABP 980. This pCR rate adds support to the claim of equivalence, and there is no clinically meaningful difference with regard to safety and efficacy. These results came after the FDA rejected the biologics license application from Amgen and Allergan in May 2018.

Kolberg says that he and his co-investigators aim to create studies that give confidence and provide new scientific data. This biosimilar will develop as a study medication, but it will be tested with new products, Kolberg says. Combining HER2-targeted therapies such as trastuzumab with immunotherapy is being tested, so that may be another place for biosimilars to get involved, he adds.
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Hans-Christian Kolberg, MD, head, Department of Obstetrics and Gynecology, Breast Cancer Center, and Gynecologic Cancer Center at Marienhospital Bottrop, Klinik für Gynäkologie und Geburtshilfe, Bottrop, Germany, discusses next steps with the trastuzumab (Herceptin) biosimilar ABP 980.

The phase III LILAC study showed an equivalent pathologic complete response (pCR) rate between trastuzumab and ABP 980. This pCR rate adds support to the claim of equivalence, and there is no clinically meaningful difference with regard to safety and efficacy. These results came after the FDA rejected the biologics license application from Amgen and Allergan in May 2018.

Kolberg says that he and his co-investigators aim to create studies that give confidence and provide new scientific data. This biosimilar will develop as a study medication, but it will be tested with new products, Kolberg says. Combining HER2-targeted therapies such as trastuzumab with immunotherapy is being tested, so that may be another place for biosimilars to get involved, he adds.

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Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: Evaluating the Emerging Role of Biosimilar Agents for the Treatment of Hematologic MalignanciesMar 08, 20193.0
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