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Sandoz and Austrian government to invest in European antibiotic manufacturing
Sandoz plans to invest €150 million and the Austrian government €50 million into integrated antibiotic manufacturing operations at Kundl.
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Novartis launches not-for-profit COVID-19 medications portfolio
The portfolio will be offered to low- and lower-middle-income countries to help financially strained healthcare systems care for COVID-19 patients.
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Five patent issues that European biosimilar developers should consider before entering the US market
As patents on originator biologic medicines begin to expire, there are growing opportunities for biosimilars to enter the market at lower prices. Joshua Whitehill, Natasha Daughtrey and Grace Truong discuss key aspects of US patent law that European developers should consider before entering the American market.
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How will the rise of biosimilars impact biologics?
Once patents expire for biologic medicines, a market opportunity opens up for biosimilars, a cheaper alternative. With more patents due to expire soon, what will the future look like for biologic medicines?
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LogiPharma announces preliminary speaker lineup and agenda
Preliminary agenda and speakers announced for LogiPharma, The World’s Leading Pharma Supply Chain Event (21 – 23 April) 2020.
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Ziextenzo™ biosimilar has received approval from the FDA
The FDA has approved Sandoz's biosimilar Ziextenzo and the company now intends to launch it in the US as soon as possible this year.
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Sandoz issues voluntary recall for medication bottles
The pharmaceutical company has announced a recall for certain prescription drug bottles which do not meet child-resistant regulations.
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FDA announces expansion of generic impurity investigation
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
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Complete response letter sent for two generic products
A complete response letter (CRL) has been sent to Dr Reddy’s for two generic products.
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Amgen wins court patent ruling over Sandoz biosimilar
The US District Court has decided in favour of Amgen’s Enbrel, ruling over Sandoz’s Erelzi in a patent conflict.
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FDA antibody biosimilar product approvals increase in 2019
2019 has seen a marked increase of antibody biosimilar product approvals in the first half of the year, according to a report.
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First patient enrolled on clinical study for denosumab biosimilar
An integrated Phase I/III trial has enrolled its first patient to test a biosimilar for denosumab to treat postmenopausal osteoporosis.
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Top five generic drug makers
The global generic drugs market continues to grow. With increasing demand for more accessible medication, pharmaceutical companies are harnessing the benefits offered by generic drugs. Here are the top five generic drugs makers by revenue.
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FDA approves Glatopa a generic option for relapsing forms of multiple sclerosis
Sandoz has announced that the FDA has approved and launch of Glatopa as a fully-substitutable, AP-rated generic version of Copaxone for relapsing forms of MS...
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British Biosimilars Association appoints new chair
The BBA, the representative group of biosimilar manufacturers in the UK, has announced that Kavya Gopal will become its new chair with immediate effect...