Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company, has announced that it has commenced a post marketing surveillance (PMS) study on FabiFlu to closely monitor the efficacy and safety of the drug in 1,000 patients that are prescribed with the oral antiviral,as part of an open label, multicenter, single arm study.
Further, Glenmark has announced a price reduction of 27% for FabiFlu. The new MRP is Rs. 75 per tab from the earlier Rs. 103 per tab. The price reduction has been made possible through benefits gained from higher yields and better scale, as both the API and formulations are made at Glenmark’s facilities in India, the benefits of which are being passed on to patients in the country.
Glenmark has successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its own in-house R&D team within the country, ensuring self-reliance with regard to long-term production and manufacturing. The API is manufactured at the Gujarat production facility which is US FDA & UK MHRA approved. The formulation product is manufactured at the facility in Himachal Pradesh, which is also US FDA and UK MHRA approved.
Alok Malik, senior vice president & head – India business, Glenmark Pharmaceuticals Ltd., said, “We expect this post marketing surveillance study to shed more light on the drug’s clinical effectiveness and safety in a large cohort of patients prescribed FabiFlu. Our priority from the start of this pandemic has been to offer patients in India an effective treatment for COVID-19, while also ensuring accessibility to the masses. Our internal research shows us that we launched FabiFlu in India at the lowest market cost as compared to the cost of favipiravir in other countries where it is approved. And now we hope that this further price reduction will make it even more accessible for patients across the country.
Despite investing significantly in R&D, clinical trials and the manufacturing of FabiFlu (API and formulations), Glenmark has managed to keep the pricing of FabiFlu lower as compared to its price in other countries. FabiFlu in India was originally launched at Rs. 103/tab, while, its price as INR is higher in the remaining countries. (Rs. 600/tab in Russia, Rs. 378/tab in Japan, Rs. 350/tab in Bangladesh and Rs. 215/tab in China).