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Latest From Anju Ghangurde
Amid glaring healthcare gaps in emerging markets like India, Novartis has scaled up its unique for-profit social business; similar initiatives are running in Kenya and Vietnam. Scrip brings you an on the ground report from rural India, where the Swiss multinational is trying to make a difference in a sustainable way.
By carrying out certain corrective and preventive actions, a Biocon facility in Bangalore, India, averted an "official action indicated" finding US FDA officials had proposed in an establishment inspection report, one that could have potentially delayed approval of two Mylan biosimilars. Key issues at the site included visible particles in sterile injectable drug products as well as various aseptic processing practices.
USV has joined the list of firms seeking clearance for biosimilar pegfilgrastim in Europe. Managing director Prashant Tewari says the company is “well geared” to address potential price competition and maintains that biosimilarity of USV’s pegfilgrastim with the innovator product has been established “satisfactorily”.
The Organization of Pharmaceutical Producers of India (OPPI) essentially reflects the views of foreign firms in the country. In an interview with Scrip, OPPI’s new chief and GSK vice president (South Asia) and managing director (India) Annaswamy Vaidheesh shares the industry body’s take on several critical issues including the Indian government’s push for generic medicines and why the effective contract manufacturing model should not be “disrupted” by proposed policy reform.
Glenmark-Celon’s generic Seretide Accuhaler dry powder inhaler (DPI) appears on course for a debut in Europe, piling up more pressure on GlaxoSmithKline’s respiratory franchise. Substitutability of the generic, however, will be key to driving momentum in uptake.
India has outlined key aspects of its recently introduced perpetual licensing system, including initial modalities around joint inspections of manufacturing units by central and state drug inspectors.