Pembrolizumab (Keytruda) Biosimilar Antibody Pipeline Review
Pembrolizumab (Keytruda) Biosimilar Antibody Pipeline Review
Reference Product: Keytruda
Target: Programmed death-1 (PD-1) receptor
Product Category: Antibody
This product provides basic information on drug candidates in research and development as biosimilar antibodies of Keytruda (pembrolizumab).
This product consists of:
- Competitors described in a tabular format covering drug code/INN, target(s)/MoA, class of compound, territory of main competitor, indication(s) & R&D stage.
- Project History with link to source of information (press release, homepage, abstracts, presentations, annual reports etc).
- One-month online access to La Merie Publishing’s database for pembrolizumab (Keytruda) biosimilars (prerequisite: access to internet).
This product is delivered on the very same day by e-mail containing competitor and project history reports in pdf format and database credentials. Reports are prepared on the same day.
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.
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.