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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.
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EMA to review Sandoz biosimilars adalimumab and infliximab
Sandoz announced that the EMA has accepted for regulatory review for biosimilars to AbbVie's Humira (adalimumab) and Janssen's Remicade (infliximab)...
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Sandoz proposed biosimilars recommended for EU approval
25 April 2017 | By Niamh Marriott, Junior Editor
The Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz's (a Novartis division) biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines.
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Sandoz biosimilar adalimumab study shows equivalent efficacy
14 March 2017 | By Niamh Marriott, Junior Editor
Sandoz, a Novartis division, presented data for its proposed biosimilar adalimumab, GP2017, showing that their Phase III study met its primary endpoint...