Biotech giant Roche drags takes drug pricing watchdog NPPA to court
Recent reports state that National Pharmaceutical Pricing Authority (NPPA) — which is considered as India’s drug pricing watchdog — was dragged to court by Biotech giant Roche over the ceilling price it fixed for breast cancer injection trastuzumab.
The Switzerland-based company sells the injection under the brand name Herceptin internationally and Herclon in India.
Recently, the NPPA issued a notification capping the price of trastuzumab 440mg/50ml injections at Rs. 55,812.29 per pack. According to pharmacy chains, Herclon is available for Rs. 75,000 per 10ml vial and at a discounted price of around Rs. 60,000.
To reach the decision, an NPPA working sheet showed, the agency considered the prices of trastuzumab injections sold by Biocon (CANMAb), Mylan (Hertraz) and Emcure Pharma (Biceltis). Emcure is Roche’s local partner, under a deal signed in 2013.
The NPPA’s price control order has come amid increasing call from activists groups to make life saving medicines affordable to the needy. Trastuzumab is included in the National List of Essential Medicines 2015.
Roche said the Biocon and Mylan products weren’t biosimilars, or copies, of its injection. In the Delhi High Court, it argued that the NPPA
“incorrectly” calculated the ceiling price using drugs that were not biosimilar to the original trastuzumab that it owns.In fact, Roche is involved in a raft of legal battles with biosimilar companies and the government over copies of Herclon and another cancer drug, Avastin (bevacizumab).
NPPA’s computation of the ceiling price was also done without taking into account the price of Herclon, according to Roche’s petition.
NPPA Chairman Bhupendra Singh told that the NPPA, on its part, maintains that its price fixation is as per law. NPPA did examine Roche’s representation and has taken a conscious decision that, legally, we could fix the ceiling price and should do it in public interest.
The prices offered by Biocon and Mylan are much below the Swiss biotech firm’s, Roche’s counsel P. Chidambaram argued in court last week. Emcure’s price to retailer (PTR) for Biceltis is shown at Rs 57,142.86, while CANMAb and Hertraz are priced at Rs. 47,618.76 and Rs. 43,601.90, respectively, according to the drug regulator’s working sheet.
Roche had sent a letter to NPPA informing that the Delhi High Court had passed an order on April 25 holding that Biocon and Mylan’s drugs did not qualify as biosimilar of trastuzumab, according to the petition. Roche also asserted that biosimilars could not be considered in the same basket while determining the ceiling price under the Drug Price Control Order.
When contacted, a Roche spokesperson said: “We cannot comment as the matter is subjudice.”
The case will be heard next on May 30.
