Pembrolizumab (Keytruda) Biosimilar Antibody Pipeline Review
Developed by Merck & Co., the blockbuster therapeutic antibody Keytruda (pembrolizumab) was first approved by the FDA in 2014 to treat several types of cancer. Since getting the initial green light, Keytruda has been approved for new and expanded uses, including melanoma, non-small cell lung cancer, head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancers, gastric cancer, cervical cancer, and primary mediastinal B-cell lymphoma.
The very recent approval of Keytruda for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma marks the third endometrial carcinoma indication and the 40th indication overall for KEYTRUDA in the U.S.
Key patents of Keytruda will begin to expire in 2028, opening the door to biosimilar competition. In 2023, Keytruda posted global sales of US$ 25 bln which are already far higher than peak sales of anti-TNF antibody Humira in 2022 (US$ 21.6 bln) before declining to US$ 14.6 bln in 2023 due to biosimilar competition. No wonder, that the Keytruda biosimilar antibody pipeline has begun to grow and now already has more than eight Keytruda biosimilar candidates in clinical development.
Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product.
La Merie Publishing released its newest product reviewing the pipeline of drug candidates in research and development as biosimilar antibodies of Keytruda (pembrolizumab): "Pembrolizumab (Keytruda) Biosimilar Antibody Pipeline Review".
August 1, 2024
