Page 21 - Biocon

Biocon, Mylan launch insulin biosimilar Semglee in Australia market

Insulin Glargine is used for the treatment of type 1 diabetes mellitus in adults, adolescents, and children

Biocon to set up R&D facility in India to boost biosimilars development

Biocon has acquired some assets from Pfizer Healthcare to set up its second R&D plant in India

Biocon subsidiary acquires research facility from Pfizer Healthcare

Biotechnology major Biocon on Tuesday said its subsidiary has acquired a Chennai-based biological research facility from Pfizer Healthcare for an undisclosed amount. Biocon Biologics has acquired research and development (R&D) capital assets of a 60,000-square feet research facility at Ticel Bio Park in Chennai, Biocon said in a statement. The high-end integrated R&D facility in Chennai will enable Biocon Biologics to expand its R&D capability and accelerate its journey towards meeting its strategic long-term goal of addressing the needs of millions of patients worldwide," Biocon Biologics CEO Christiane Hamacher said. This investment will allow the company to fast-forward development of its biosimilars from lab to pilot scale, he added. The facility will house an early stage research and innovation centre, including a pilot scale R&D unit equipped with cell line development, drug product formulation laboratories and analytical R&D laboratories. The facility is ...

Biocon forays into China, signs pact with CMS to sell 3 generic products

According to data, the total market size for these three generic products in China is about $0.8 billion

Biocon looks to derive sales from US, EU to break even at Malaysia unit

According to an Edelweiss report, investments would pick up at the company subsidiary in the current financial year

Ramp up of biosimilar portfolio may add wings to Biocon, say analysts

Approval by European Union for the company's Malaysian facility will provide huge fillip to its capacity and drive growth

Biocon's Malaysia arm gets good manufacturing certificate from EU regulator

The Malaysian facility was inspected in May 2019; it is Asia's largest integrated insulin facility and manufactures drug substance and drug products in vials, cartridges, and insulin delivery devices

Top 10 business headlines: GDP estimates for Q1FY20, CG Power fiasco & more

From a probe at CG Power finding fraudulent related-party transactions to the IL&FS board seeking NCLT approval to sell 7 wind assets to Orix Corp, here are the top business headlines for Wednesday

Our aim is to be a global leader in biosimilars biz: Biocon Biologics CEO

Margins of biologics stood at 38% in Q1 as compared to 33% in the preceding quarter

Biocon Q1 net profit rises 72% to Rs 206 crore; total income up 25%

Net profit, excluding exceptional item, stood at Rs 223 crore reporting growth of 86 per cent

USFDA issues 12 observations for three units of Biocon in Malaysia

The company, however, did not provide any details about the observations made by the US regulator

Boost to Biocon's biosimilar business as Bengaluru units get European nod

Facilities were inspected by the European Medicines Agency in March; Analysts foresee firm posting double-digit growth in revenue and profits despite rising competition

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