Page 10 - Biocon

Biocon and Mylan get Canadian nod for biosimilar cancer drug Ogivri

Mylan will launch the product during this quarter; global market size of the generic is $7 billion

Biologics to boost Biocon business over the next 3 years, say analysts

Biologics accounted for 27% of total revenue in FY19

Biosimilar launches in emerging markets to drive Biocon earnings further

More launches in biosimilars and Syngene may drive earnings further, say analysts

Biocon gets 6 observations from USFDA after inspection of Bengaluru plant

Biotechnology major Biocon Wednesday said the US health regulator has issued six observations in Form 483 after pre-approval inspection of its insulin drug substance manufacturing facility in Bengaluru. The United States Food and Drug Administration (USFDA) concluded a pre-approval inspection of Biocon's insulin drug substance manufacturing facility triggered by a New Drug Application submitted by the company's insulin API customer, a company spokesperson said in a statement. "The inspection at the Bengaluru facility took place between February 25-March 5, resulting in a Form 483 with six observations," it added. Biocon is confident of addressing these expeditiously and remains committed to global standards of quality and compliance, the statement added. The FDA Form 483 is issued to a firm's management at the conclusion of an inspection "when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act ...

Biocon Q3 net profit zooms over two-fold to Rs 217.2 cr on biologics bizz

Its consolidated revenue from operations stood at Rs 1,540.8 cr for the quarter, against Rs 1,057.9 cr

Biocon likely to channelise investments towards non-insulin biologics

Globally, the insulin business has come under pressure

Biocon increases presence in developed markets via biosimilars portfolio

Launches in developed markets will nearly double profit in FY20, say analysts

Biocon's biosimilar of cancer drug gets European Commission approval

Ogivri is indicated for the treatment of patients with HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer

USFDA completes inspection of Biocon's Telangana plant, finds no fault

A Form 483, is issued by the USFDA to notify a company's management of any objectionable condition at its manufacturing facility

Biocon aims to be global biopharma leader in 20 yrs: Kiran Mazumdar-Shaw

' While the company's insulin business recorded a strong growth in several emerging markets, its cancer biosimilar Fulphila became the first pegfilgrastim biosimilar to be available to patients in US

Biocon's Malaysia insulin facility on the path to break even in FY19

Insulin Glargine is the first biosimilar from India to be approved and launched in Japan

Biocon: Biosimilar launches prop up Q2 show; healthy returns seen in future

The strong momentum is likely to continue, led by biosimilars and steady show of other segments

Biocon one step closer to Europe nod for biosimilar of breast cancer drug

Firm obtains positive opinion on approval of Ogivri, a biosimilar to Roche's Herceptin (trastuzumab); final decision by year-end

Biocon hits new high; stock zooms 109% in one year

The stock hit a new high of Rs 718, rallying 8% in two days after the company's drug substance manufacturing site at Bengaluru campus by the US health regulator has concluded without any observations.

Biocon and Mylan's cancer biosimilar gets CHMP nod for approval in EU

The CHMP opinion for the drug to be sold under the named Fulphila will now be considered by the European Commission and the decision on approval is expected by November

Biocon targets $200 mn revenue from biosimilars on the back of EMs growth

The approval of Biocon's biosimilar insulin Glargin in about 25 countries will be a revenue driving force

Biocon Q1 net profit up 47% on strong biologics, research services business

The company gained market share in several emerging markets such as Malaysia, Algeria and UAE

For Biocon, regulatory nod to give boost to biosimilar monetisation

EU's clearance to firm's Bengaluru plant increases chances of its drug approval, launches

Biocon receives USFDA report on closure of inspection for Bengaluru unit

Biocon said that it is committed to global standards of quality and compliance in a BSE filing after receiving the Establishment Inspection Report

Biocon shares hit record high as cancer drug Pegfilgrastim gets USFDA nod

The stock hit a record high of Rs 695, up 6% on the BSE in opening deal in otherwise weak market.