Biocon gets Form 483 observations for API plant

The US Food and Drug Administration has issued a Form 483 with five observations for Biocon’s API Manufacturing facility. Form 483 observations are issued when US FDA inspectors notice shortcomings in a company’s manufacturing processes, data storage and so on during an inspection. The company has to address the issues raised in the Form 483 […]

Syngene COO steps down to explore “startup opportunity”

Syngene International Ltd, the contract research unit of Biocon, announced the resignation of its chief operating officer Manoj Nerurkar. It said Nerurkar, who has been with the COO of the company for nine years, will step down to an advisory role from October to pursue “an external start up opportunity outside of contract research services”. […]

Biocon’s Bangalore plant passes USFDA inspection without incident

Biocon, one of India’s foremost research-oriented pharmaceutical companies, said the US drug regulator has completed an inspection at its Bangalore facility without remarks. “The US FDA conducted a periodic cGMP inspection of our Drug Substance manufacturing site at Bangalore Campus from Sep 17 – 21, 2018. “The week-long audit concluded without any observations and no […]

Biocon, Mylan get approval for glargine insulin in Europe, Australia

Pharmaceutical manufacturer Biocon and its partner Mylan received marketing approval for their glargine insulin product Semglee in European Union and Australia, marking the first biosimilar approval for the partnership in Europe. Biosimilars are drugs that mimic or imitate the actions of natural proteins or enzymes in the body, such as insulin. Glargine insulin, which is […]

USFDA issues Form 483 on Biocon’s Malaysia manufacturing plant

The United States’ Food & Drug Administration has issued a Form 483 after inspecting Biocon’s Malaysia manufacturing plant, indicating that it found discrepancies during the inspection. Issue of Form 483 means that the plant has not been approved for production of medicines in its current shape, and must be modified under a ‘corrective and preventive […]

Crucial win for Biocon as FDA approves cancer biosimilar trastuzumab

Biocon and its partner Mylan scored a key victory on Friday as the US Food & Drug Administration approved its cancer-treating biosimilar trastuzumab. “Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan’s ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier […]

EU accepts Biocon, Mylan’s application for cancer biosimilar pegfilgrastim

Indian pharma company Biocon and its partner Mylan said EU authorities have accepted for review their applications for approving cancer treating biosimilars trastuzumab and pegfilgrastim submitted after completing corrective actions. The applications were resubmitted last month after being pulled in August in response to audit observations relating to one of Biocon’s drug facilities. At the […]

Biocon, Mylan apply again for EU approval for cancer drugs trastuzumab, pegfilgrastim

Biocon said its partner Mylan has resubmitted the marketing application for two substances used to treat cancer — trastuzumab and pegfilgrastim — before European authorities after making changes to their production facilities. The drug applications before the European Medicines Agency (EMA) were withdrawn in August after the authorities refused to issue approval without reinspecting the […]

USFDA returns Mylan-Biocon’s drug application for more data

The U.S. Food and Drug Administration has sought more data before approving a chemotherapy compound submitted by Mylan and jointly developed by Biocon. The agency issued a ‘complete response letter’. Such letters are issued when an FDA review an FDA review finds that an application for a new drug cannot be approved ‘in its present […]

Biocon passes US-FDA inspection at Vishakapatanam plant

Biocon said the plant inspection conducted by the US Food and Drug Administration at its Vishakapatanam plant passed without incident. “US FDA inspected our Active Pharmaceutical Ingredients (API) manufacturing facility in Wishakhapatnam, Andhra Pradesh from September 11 to 15, 2017 and completed the audit without any observations,” it said. No form 483 was issued, it […]

Mylan and Biocon submits breast cancer drug application to USFDA

Mylan N.V. and Biocon Ltd. said they submitted Mylan’s biologics license application for a proposed biosimilar Trastuzumab, to the U.S. Food and Drug Administration. Biosimilar trastuzumab is a proposed biosimilar to branded Trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. HER2-positive breast cancer is a breast cancer that tests positive for […]

EMA accepts review for Mylan and biocon’s trastuzumab biosimilar

Mylan N.V. and Biocon Ltd. said the European Medicines Agency accepted for review Mylan’s Marketing Authorization Application for a proposed biosimilar version of biosimilar Trastuzumab, a medicine used to treat breast and gastric cancers. This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe. Mylan’s MAA for […]

Biocon’s European approval for cholesterol drug opens $1.2 billion market

Biocon Ltd said it has received European approvals for generic versions of AstraZeneca’s cholesterol drug Crestor, opening up a billion dollar market. The approval has been obtained for Rosuvastatin Calcium 5 mg, 10 mg, 20 mg and 40 mg tablets, indicated for hyperlipidemia or mixed dyslipidemia. Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw said: “This […]