Dr. Reddy’s introduces in-house palbociclib (PRIMCYV®)

Pfizer Products India Pvt Ltd has announced that Dr Reddy’s Laboratories Ltd. has acquired the trademark rights to the breast cancer drug PRIMCYV for use in the Indian market. PRIMCYV is a targeted therapy that contains the active constituent palbociclib, a first-in-class CDK 4/6 inhibitor indicated for the first-line treatment of adult patients with HR+, HER2- metastatic breast cancer in combination with an aromatase inhibitor.

Dr. Reddy’s has been marketing the drug in India under the brand name PRIMCYV since May 2022, in collaboration with Pfizer Products India Pvt Ltd. The medication is available in 75 mg, 100 mg, and 125 mg hard capsules. Following the acquisition of the trademark rights, Dr. Reddy’s will manufacture the Active Pharmaceutical Ingredient (API) and finished drug in state-of-the-art facilities approved by the US Food and Drug Administration (USFDA).

According to the filing, Dr. Reddy’s is one of a few companies worldwide that has conducted a bioequivalence study and received preliminary approval from the USFDA for palbociclib. To increase affordability and access to palbociclib, the in-house product will be retailed in the Indian market at a discount of 85% from the current MRP. Dr. Reddy’s plans to launch a one-of-a-kind Patient Assistance Program to help patients on PRIMCYV maintain long-term therapy, according to a company statement.

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