Amgen has announced that the FDA has issued a Complete Response Letter for its biosimilar trastuzumab candidate, ABP 980.
Amgen has announced that the FDA has issued a Complete Response Letter (CRL) for its biosimilar trastuzumab candidate, ABP 980. In a brief statement on its website, Amgen said that it would work closely with the FDA on the product, and that it did not expect the CRL to impact its US launch plans. Amgen and its partner, Allergan, submitted their Biologics License Application for the drug in August 2017.
Amgen previously released complete phase 3 results from a study in patients with HER2-positve early breast cancer at the 2017 annual meeting of the European Society for Medical Oncology in Madrid, Spain. The study compared the proposed biosimilar with the reference Herceptin, and the primary endpoints were risk differences (RD) and risk ratio (RR) of pathologic complete response (pCR).
By local review, the primary pCR endpoint was achieved in 48.0% of patients in the ABP 980 arm versus 40.5% of those in the reference trastuzumab arm. The advantage for the biosimilar exceeded the prespecified 13% margin for bioequivalence by RD. While the lower boundary of the 95% confidence interval (CI) for RD exceeded 0% (1.2%), the upper boundary surpassed 13% (13.4%), which met the criterion of a significant advantage. The RR on local review analysis showed the same result. However, the prespecified margins were not exceeded in the central review.
The safety profile of ABP 980 was also similar to that of the reference product; when adverse events were compared collectively and individually, the rates were similar for ABP 980 and reference trastuzumab over the course of neoadjuvant treatment.
Despite today’s US regulatory setback, the drug was, on May 30, 2018, listed on the European Medicines Agency’s (EMA) website as having achieved the European Commission’s authorization on May 16, 2018 for marketing under the brand name Kanjinti. The biosimilar is approved in the indications of early breast cancer, metastatic breast cancer, and metastatic gastric cancer. The drug received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use in March 2018.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.