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QuintilesIMS Blog

Fresh ideas and insights from our experts around the globe

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Brazilians flock to pharmacies: How healthcare companies can bolster sales by embracing this shifting shopper trend
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Ray Huml
With patent expirations looming, biologic companies must innovate – or litigate – to protect their market share.
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Ray Huml
Nigel Rulewski
Ray Huml
Ray Huml
A look at the six challenges companies face when pursuing this potentially lucrative development path.
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Jaclyn Bosco
ISPOR workshop examines the post-approval biosimilar experience and the role real-world evidence plays in their success.
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Nigel Rulewski
How to accelerate recruiting for biosimilars Phase I trials.
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AnandTharmaratnam
Biosimilars offer a huge opportunity in Asia to bring effective treatment options to a population desperate for cost-effective treatments.
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Nigel Rulewski
March 6, 2015 was a landmark day for the biosimilar manufacturers. It is the day that U.S. Food and Drug Administration (FDA) approved a biosimilar version of filgrastim, making it the first biosimilar product to enter the U.S. market. The approval was no great surprise. An abbreviated licensure pathway for biosimilars approval in the U.S. was established in 2010 as part of the Affordable Care Act, and filgrastim offered an attractive package of attributes making it a prime candidate for FDA’s first step into this new product category. A biosimilar version of filgrastim has been on the European market for years, and the makers can provide hundreds of thousands of days of patient outcomes data, post approval, which provides FDA with deep assurances around its safety and efficacy. I...
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Nigel Rulewski
In a historic step, on March 6, 2015 the U.S. Food and Drug Administration (FDA) approved the first ever biosimilar product for the U.S. market.  An abbreviated licensure pathway for biosimilars approval in the US was created in 2010 through the Biologics Price Competition and Innovation Act, which is part of the Affordable Care, but this is the first drug to make it through that process.
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