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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...
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Sandoz proposed biosimilar pegfilgrastim accepted by EMA
Sandoz has announced that its biosimilar pegfilgrastim has been accepted by the EMA for regulatory review...
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Sandoz receives EU approval in Europe for Rixathon (biosimilar rituximab)
The EC has approved Sandoz’ Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine...
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Sandoz receives EU approval for Erelzi (biosimilar etanercept)
The European Commission (EC) has approved Sandoz’ (a Novartis division) Erelzi (biosimilar etanercept) for use in Europe, to treat inflammatory diseases...
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FDA accepts application for generic version of Advair Diskus
The FDA has accepted Sandoz’s New Drug Application for fluticasone propionate / salmeterol combination product, a generic version of Advair Diskus...
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AAM praises Supreme Court Ruling granting access to biosimilars
The Association for Accessible Medicines (AAM) applauded the US Supreme Court’s decision this week in Sandoz Inc. v. Amgen Inc. that will help speed patient access to biosimilar versions of expensive brand-name biologic medicines.