Amgen and Allergan announced today that the companies have submitted a Biologics License Application for ABP 980, a proposed trastuzumab (Herceptin) biosimilar.
Amgen and Allergan announced today that the companies have submitted a Biologics License Application (BLA) for ABP 980, a proposed trastuzumab (Herceptin) biosimilar.
The companies’ BLA submission includes data from a phase 3 comparative efficacy, safety, and immunogenicity study conducted in adult female patients with HER2-positive early breast cancer. The partnership also filed for approval of the product with the European Union’s European Medicines Agency in March of 2017.
"The submission of ABP 980 for FDA review is an exciting milestone and speaks to our joint commitment with Allergan to deliver quality oncology biosimilars to patients," said Sean E. Harper, MD, executive vice president of research and development at Amgen. "Approval of ABP 980 would provide more patients access to a high-quality therapy with a proven safety and efficacy profile. We look forward to further discussions with the FDA."
Allergan’s chief of research and development, David Nicholson, added, "We're proud of the progress we've made so far and look forward to continuing our work to bring more biosimilars to market."
US-based Amgen and Ireland-based Allergan are collaborating on 4 biosimilar products, including ABP 980, for oncology indications. In July, the partnership received a unanimous recommendation for approval from the FDA’s Oncologic Drugs Advisory Committee (ODAC) for another of those products, ABP 215, a proposed bevacizumab (Avastin) biosimilar. The FDA’s decision on ABP 215 is expected in September.
The Amgen—Allergan partnership’s filing comes just 1 day after Celltrion and Teva announced a trastuzumab biosimilar BLA of their own. The Celltrion—Teva product, CT-P6, also relies on data from a phase 3 equivalence trial in patients with HER2-postive early breast cancer.
However, the first biosimilar trastuzumab product expected to penetrate the US market is Mylan and Biocon’s trastuzumab, MYL-1401O, which has a Biosimilar User Fee Act date of September 3, 2017. The product recently received a unanimous ODAC recommendation for approval. The Mylan—Biocon product is expected to be the first biosimilar challenger to the reference Herceptin after Mylan entered a global settlement with the reference product’s sponsor, Genetech, in March. The settlement has provided Mylan with a global license to commercialize MYL-1401O after approval.