Breaking News

You are here » Indian-Commodity  :  Top News  :  Biocon, Mylan N.V. receive positive CHMP opinion for Ogivri

20-Oct2018

Biocon, Mylan N.V. receive positive CHMP opinion for Ogivri

Biocon and Mylan N.V. have announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ogivri, a biosimilar to Roche's Herceptin (trastuzumab).

The positive CHMP opinion is based on data submitted as part of the Marketing Authorization Application which included similarity assessment in analytical testing, preclinical and clinical studies. The CHMP positive opinion will now be considered by the European Commission. The decision on approval is expected by the end of 2018.

Biocon is India's largest and Asia's leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.


Related News

View all news

Crude oil futures end lower on Tuesday

Crude oil futures ended lower on Tuesday with benchmark finishing at its lowest in over a year, as investor attention remained fixed on supply ahead of a key meeting of major oil producers early next month.......

Gold futures end tad lower on Tuesday

Gold futures ended marginally lower on Tuesday, retreating from four-day winning streak, owing to a firmer US currency amid better than expected US housing data. Meanwhile, investors were cautious as they......

Copper futures end lower as world stocks fall

Copper futures ended lower on Tuesday, as world stock markets fell in a tech-led sell-off, while the dollar index rallied from a two-week low, making commodities priced in the greenback more expensive......

Top News

View all news

Megastar Foods planning to incorporate subsidiary

Megastar Foods is planning to incorporate a subsidiary Company. The meeting of the Board of Directors of the company is scheduled to be held on November 27, 2018, to consider the same. Megastar Foods is......

Lupin launches generic Tetrabenazine Tablets

Lupin has launched Tetrabenazine Tablets, 12.5 mg and 25 mg having received an approval from the United States Food and Drug Administration (USFDA) earlier. Lupin's Tetrabenazine Tablets, 12.5 mg and 25......

UPL's arm signs definitive agreement to acquire entire stake of IBC

UPL's wholly owned subsidiary-- UPL Corporation, Mauritius has signed a definitive agreement to acquire directly or through its subsidiaries 100% of the shares of INDUSTRIAS BIOQUIM CENTROAMERICANA, SOCIEDAD......