News & Events
Mylan ($MYL) and Bangalore-based Biocon said that the European Medicines Agency has accepted an application for review for marketing authorization of a biosimilar of pegfilgrastim (Neulasta) as both firms push wider into developed markets eager for lower-cost versions of blockbuster drugs.
In a release, the companies said the EMA review will focus on clinical data gathered for the submission of the therapy aimed at neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy.
The companies said they expect to present data on the clinical studies separately at the European Society of Medical Oncology annual congress in October.
Last month, Kiran Mazumdar-Shaw told the Business Standard that Biocon is a frontrunner in the biosimilar race in the European Union and the United States as it builds on a launch in Japan of a biosimilar of Sanofi’s ($SNY) blockbuster Lantus (insulin glargine) that showed its chops.
“For a long time, our stock was being crucified because they thought we would never be able to get into the so-called developed markets,” she said in June.
India may take a long-expected step in parliament near the end of the year to create a separate law on medical devices that fits in with the manufacturing aims of the government led by Prime Minister Narendra Modi.
The Business Standard newspaper reports that the prime minister’s office brought up the plans in a meeting with industry and said that a Medical Device Act would likely come in the winter legislative session that typically starts in late November and ends before the New Year.
Currently, India has several laws responsible for devices, including under the Drug and Cosmetics Act of 1940, which is also the subject of efforts for an overhaul on the pharmaceutical side.
In both cases, legislative changes sought by industry and the government to reform the way the biomedical industries work and are regulated in the country have been hard to fashion as plans for more outside investment run into domestic industry opposition.
But Modi has said that both pharmaceutical and medical device manufacturing are key for his “Make in India” campaign to spur job growth and has pushed domestic players to get on board and compete in the market at home and abroad.
India has finally decided to place caps on the prices of at least two categories of heart stents with the issue going back and forth for the past year. The move drew brickbats from a manufacturing industry lobby group.
The two categories–drug-eluting and bare metal–heart stents will be included in the country’s National List of Essential Medicines, according to the Economic Times, setting the stage for the National Pharmaceutical Pricing Authority to set price caps that could see a drop of 40% to 70% from current levels, according to earlier reports.
The decision to include stents in the essential category of medicines and devices comes as coronary disease in India rises as a public health hazard, with the cost of the devices playing a key factor in seeking surgery for patients paying out-of-pocket.
A sub-committee of expert cardiologists had recommended the caps and the details on pricing are expected soon.