Dr Reddy’s Laboratories launched Peg-grafeel, Dr Reddy’s brand of pegfilgrastim in India. Peg-grafeel has been approved in India to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy with the exception of chronic myeloid leukaemia and myelodysplastic syndromes.
Pegfilgrastim is a pegylated long-lasting variant of filgrastim. One injection of pegfilgrastim can replace up to 14 injections of filgrastim, which must be administered daily. It can be administered once per chemotherapy cycle, providing convenience to the patient while eliminating many of the additional costs of treatment.
Peg-grafeel is priced at an MRP of Rs.8,865 and represents a breakthrough in the pricing of this complex molecule. It is priced at approximately 25 per cent of the originator brand in India, and is priced 95 per cent lower than the US price for pegfilgrastim. This breakthrough in pricing has been enabled by Dr Reddy’s vertically integrated global manufacturing network. Peg-grafeel is manufactured using Dr Reddy’s ‘PEGtech’ brand of activated mPEGs which are synthesised at its facilities located in Mexico and the UK.
Commenting on the launch, GV Prasad, vice-chairman and CEO, Dr Reddy’s said, “Peg-grafeel will offer patients in India an important alternative. An affordable pegfilgrastim will redefine the way patients undergoing treatment with chemotherapy can reduce the duration of neutropenia and highlights our commitment to provide affordable and innovative medicines to patients in India. We also intend to market Peg-grafeel globally, on our own and through partners.”
Pegfilgrastim was first approved for use in 2002 by the US FDA. Since its introduction it has quickly replaced filgrastim as the standard of care in most of the world due to its convenient (once per chemotherapy cycle) dosing schedule. It was first introduced in India in 2007, and currently several brands of pegfilgrastim are available. However, in India, pegfilgrastim is an expensive alternative to filgrastim, priced up to Rs.34,000 for a single injection. As a result, filgrastim remains the standard of care in India.
Neutropenia is the condition in which a patient has a lower than normal white blood cell count and is a common side effect of many chemotherapy regimens. Having a low white blood cell count leaves patients vulnerable to life threatening infections. Febrile neutropenia is a potentially fatal condition where a patient with neutropenia develops a fever due to an infection. Filgrastim and pegfilgrastim are medicines that stimulate the body to produce white blood cells, thereby reducing the duration of neutropenia and the incidence of febrile neutropenia in patients undergoing treatment with chemotherapy.
PEGtech is Dr Reddy’s brand for its extensive range of activated mPEGs. The mPEG alcohol manufactured in Mexico is supplied to Dr Reddy’s c-GMP facility in Mirfield, UK where commercial scale activation is carried out.
Pegfilgrastim, developed by Amgen Inc. was approved for use in 2002 and is sold as Neulasta in US and EU. Pegfilgrastim is marketed in India by F. Hoffmann-La Roche as Neulastim since 2007. It is currently also sold by Intas, and Gennova/Emcure. Brands include Neupeg, Pegasta and Pegex.