On Sept. 1, 2020, NeuClone Pharmaceuticals announced that they are developing biosimilar candidates referencing OPDIVO and KEYTRUDA.
According to NeuClone, the two biosimilar candidates “are in the advanced states of pre-clinical development.” This brings the number of NeuClone’s biosimilar pipeline to 8 announced products with another 12 in development that are yet to be announced. Development of the two biosimilar candidates are part of a co-development partnership between NeuClone and Serum Institute. Under the partnership, “NeuClone is responsible for initial biosimilar development, analytical characterization and biosimilarity confirmation.” Serum Institute is responsible for manufacture through multiple stages spanning scale-up, clinical, and commercial manufacture. After the completion of all clinical programs, NeuClone has marketing rights in the United States, Australia, New Zealand, Europe, Canada, Japan, South Korea, and China while Serum Institute has marking rights for the rest-of-world markets.
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