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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.
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?
Preliminary agenda and speakers announced for LogiPharma, The World’s Leading Pharma Supply Chain Event (21 – 23 April) 2020.
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.
The pharmaceutical company has announced a recall for certain prescription drug bottles which do not meet child-resistant regulations.
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
A complete response letter (CRL) has been sent to Dr Reddy’s for two generic products.
The US District Court has decided in favour of Amgen’s Enbrel, ruling over Sandoz’s Erelzi in a patent conflict.
2019 has seen a marked increase of antibody biosimilar product approvals in the first half of the year, according to a report.
An integrated Phase I/III trial has enrolled its first patient to test a biosimilar for denosumab to treat postmenopausal osteoporosis.
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.
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...
The BBA, the representative group of biosimilar manufacturers in the UK, has announced that Kavya Gopal will become its new chair with immediate effect...
Sandoz has announced that its biosimilar pegfilgrastim has been accepted by the EMA for regulatory review...
The EC has approved Sandoz’ Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine...
