Sun Pharma launches generic version of Pfizer's blockbuster cancer drug

Sun Pharmaceutical Industries has launched the generic version of Pfizer's breast cancer medicine palbociclib in India on January 11. The entry of the generic medicine became possible after Pfizer's Indian patent on the product expired this month. The generic versions of the drug are also being readied by a handful of other Indian companies like Cipla and Dr Reddy's, and the price of the medicine is likely to come down significantly in the coming days, industry experts said. Pfizer's palbociclib, branded as Ibrance, has patent protection in the US till March 5, 2027 and is approved in more than 100 countries and has been prescribed to more than 350,000 patients globally.

The launch of the generic version has come weeks after a group of qualified medical doctors among the members of the Lok Sabha and Rajya Sabha who are part of the Indian Medical Parliamentarians' Forum (IMPF) asked Prime Minister Narendra Modi to intervene in the issue of high cost of cancer medicines.

With the generic versions available, the price of the palbociclib treatment, which used to be at least ₹50,000 a month, will come down substantially. While Sun Pharma did not disclose the price at which the company will sell palbociclib (under the brand name Paleno), industry sources say the generic versions could be as low as ₹10,000 or less. Even the price of Pfizer's Ibrance is expected to reduce considerably if the patient assistance programme is taken into account, they say.

Meanwhile, a press release issued by Sun Pharma said the company will make the drug Paleno available in three strengths — 75 mg, 100 mg and 125 mg.

"We are introducing palbociclib at an affordable price which will help improve patient access. Paleno will address the treatment needs of several advanced breast cancer patients in India. For the first time, we are introducing a unique patient assistance program that will improve patient compliance and accessibility," Kirti Ganorkar, CEO–India Business, Sun Pharma, said.

Palbociclib is approved by the USFDA, EMA and CDSCO in combination with hormonal therapies for patients with hormone receptor positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer. Breast cancer is the largest form of cancer in India, affecting approximately 0.21 million new female patients every year. Among the total patients, approximately 50% are hormone receptor positive breast cancer, the major subtype in breast cancer.

In a letter to Prime Minister Modi on December 22, Dr Lorho S. Pfoze, a member of Lok Sabha and joint convenor of IMPF, had asked the government to appoint an expert panel to look into the issue of high cost of cancer treatment. It wanted the panel to see if the provisions for government use (Section 100) in Indian Patent Act can be invoked to facilitate generic availability of medicines used for the treatment of breast cancer in the country. It also stated that the prices of three breast cancer medicines Palbociclib, and Ribociclib and Abemaciclib were in the range of ₹48,000 to ₹95,000 for a month's dose and required urgent government intervention.

Incidentally, Pfizer's original Palbociclib patent was set to expire this year in the US too, but the US Patent Office granted a Patent Term Extension Certificate (PTE), thereby extending patent production for the medicine by more than four years until March 05, 2027. The PTE was granted under the Drug Price and Patent Term Restoration Act, 1984. While this delayed the entry of generics in the US market, it was possible in India as the current Indian patent laws does not provide for such an extension, a longstanding demand of global pharmaceutical MNCs.