Dr Reddy’s launches in-house palbociclib to widen access to breast cancer drug
Dr Reddy's is among select companies to have conducted bioequivalence study, and has already received tentative approval from the USFDA
Dr Reddy’s Laboratories has acquired the trademark rights of the breast cancer drug PRIMCYV from Pfizer Products India for use in the Indian market, according to a statement from the company.
The statement said that PRIMCYV is a targetted therapy containing the active constituent palbociclib, the first-in-class CDK 4/6 inhibitor indicated in combination with an aromatase inhibitor for the first-line treatment of adult patients with HR+, HER2- metastatic breast cancer.
Since May 2022, Dr Reddy’s has been marketing the drug in collaboration with Pfizer Products India under the brand name PRIMCYV in India. The drug comes in the form of hard capsules in strengths of 75 mg, 100 mg and 125 mg, the statement further informed.
It also mentioned that following the trademark rights acquisition, Dr Reddy’s will manufacture the Active Pharmaceutical Ingredient (API) and finished drug at its state-of-the-art facilities approved by the United States Food and Drug Administration (USFDA).
Dr Reddy’s is amongst select companies in the world to have conducted a bioequivalence study and received tentative approval from the USFDA for palbociclib. The in-house product will be retailed in the Indian market at a reduction of 85 per cent from the current MRP to increase affordability and access to palbociclib, concluded the statement.
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