Indian share markets continue to trade just below the dotted line amid weak global markets. Gains were largely seen in consumer durables stocks and FMCG stocks. Metal stocks and energy stocks witnessed majority of the selling pressure.
The BSE Sensex is trading lower by 45 points and the NSE Nifty is trading lower by 18 points. Meanwhile, the BSE Mid Cap index is trading up by 0.3% & the BSE Small Cap index is up by 0.4%. The rupee is trading at 64.43 to the US$.
Biocon share price surged over 2% after the European Medicines Agency (EMA) accepted for review Mylan’s Marketing Authorisation Applications (MAA) for proposed biosimilar Trastuzumab and proposed biosimilar Pegfilgrastim.
Trastuzumab is used to treat certain HER2-positive breast and gastric cancers. Pegfilgrastim is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.
Reportedly, EMA acceptance of the submissions follows an earlier withdrawal of both applications in response to an audit conducted by the European inspecting authority of Biocon’s drug product facility.
Biocon has completed the Corrective and Preventive Actions (CAPAs) outlined as a result of the audit observations. The CAPAs will be confirmed during re-inspection, which will be completed as part of the regulatory review process, the reports noted.
Further, Good Manufacturing Practice (GMP) compliance certificates for Biocon’s two drug substance manufacturing facilities in Bangalore have been issued previously. Approval of these sites is key in the development and approval process as drug substance manufacture is core to the production of the actual biologic product in GMP compliance.
One shall note that, Biosimilars and Biologics are burgeoning sectors in 2017 also major scientific and technological advances, coupled with socio-demographic changes and increasing demand for medicines will revive the pharma industry’s fortunes in another 10 to 20 years.
