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Biocon Biologics, Mylan get CHMP recommendation for approval of biosimilar insulin Aspart
expresspharma
December 14, 2020
Biocon Biologics (a subsidiary of Biocon), and Mylan (a subsidiary of Viatris) have received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of the market authorisation ..
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Biocon Biologics gets Rs 1, 125 cr capital injection from Goldman Sachs
expresspharma
November 09, 2020
Goldman Sachs will be issued Optionally Convertible Debentures at a post money equity valuation of $3.94 billion.
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Mylan, Biocon Biologics Announce Launch of Semglee in U.S.
americanpharmaceuticalreview
September 01, 2020
Mylan and Biocon Biologics India announced the U.S. launch of Semglee™ (insulin glargine injection) in vial and pre-filled pen presentations, approved to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with...
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Biocon Biologics and Mylan launch Semglee (insulin glargine injection) in US
expresspharma
September 01, 2020
Mylan is offering Semglee at a wholesale acquisition cost (WAC) of $147.98 per package of five 3ml pens and $98.65 per 10ml vial.
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Biocon Biologics and Voluntis collaborate on digital therapeutics for insulins
expresspharma
July 22, 2020
Insulia is the first digital therapeutic with regulatory clearance to provide automated titration recommendations for all types of basal insulins.
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Biocon Biologics gets DCGI approval for emergency use of CytoSorb to treat critical COVID-19 patient
expresspharma
May 28, 2020
Biocon announced that its subsidiary Biocon Biologics has received the Drugs Controller General of India’s (DCGI) approval for an extracorporeal blood purification (EBP) device CytoSorb.
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Biocon Biologics receives EU GMP Certification for multiple Biosimilars manufacturing facilities in
expresspharma
May 20, 2020
These facilities are used for the manufacture of DS and DP for Biosimilars: Bevacizumab, Trastuzumab, Pegfilgrastim and secondary packaging of Insulin Glargine for EU markets.
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Biocon Biologics gets EIR from US FDA for two manufacturing facilities
expresspharma
April 17, 2020
The formal closure of the US FDA inspection is expected to enable filing of marketing authorisation applications for the company's biosimilar products in several global markets.
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Biocon Biologics expands R&D footprint
biospectrumasia
September 24, 2019
The financial details of the deal are confidential.Biocon Biologics has acquired these assets from Pfizer Healthcare India Ltd.
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Biocon Biologics receive EU GMP Certification
biospectrumasia
June 16, 2019
This was a surveillance inspection of existing DP and OS facilities and a pre-approval inspection of additional DP manufacturing line