Breaking News

You are here » Indian-Commodity  :  Corporate  :  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

Torrent Pharma recalls 16 batches of losartan potassium tablets from US

Torrent Pharmaceuticals is recalling 16 batches of losartan potassium tablets from the US market due to an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by the city-based......

Bharti Infratel reports 11% rise in Q3 consolidated net profit

Bharti Infratel has reported results for third quarter ended December 31, 2018. The company has reported a rise of 47.92% in its net profit at Rs 468.90 crore for the quarter under review as compared to......

RCOM not to pay 4th installment of Rs 375 crore to NCD holders

Reliance Communications (RCOM) will not be paying the fourth installment of Rs 375 crore of principal on NCD's which is going to be due on February 7, 2019 and interest payable on NCD's till completion......

Top News

View all news

Power Finance sanctions Rs 7,785-crore term loan for Telangana irrigation project

Power Finance Corporation (PFC) has sanctioned a Rs 7,785-crore term loan in two packages for the Kaleshwaram irrigation project in Telangana. The project envisages irrigation facilities for an ayacut......

Surya Roshni incorporates WOS company

Surya Roshni  has incorporated a wholly owned subsidiary (WOS) namely Surya Roshni Led Lighting Projects, having Registered office at New Delhi (India) on January 21, 2019 vide Certificate of......

Spice Mobility incorporates foreign subsidiary in Nepal

Spice Mobility has incorporated 'Digispice Nepal', a 100% foreign subsidiary of the company, in Nepal. The main object of the company is to operate in the information technology industry and provide software......