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Amgen Inc.

www.amgen.com

Latest From Amgen Inc.

Payers Could Guarantee Biosimilar Market Share, FDA's Gottlieb Suggests

Commissioner worries that fewer drugs may enter market in some categories because of drug development costs, and offers some post-market strategies for encouraging biosimilar development.

Biosimilars Pricing Debate

Biosimilar Post-Approval Change Guidance Coming From US FDA

Guidance, which is undergoing clearance, will address other products as well and might be released by the end of the year.

Manufacturing Biosimilars

Biosimilars Statistical Guidance Reflects Early Development Approach

US FDA's long-awaited draft guidance on statistical approaches for analytical similarity testing appears to echo what agency has been telling biosimilar product sponsors in private about ranking and testing reference product attributes according to criticality.

Biosimilars Research & Development

Pfizer Skeptical About Value-Based Contracting In Current Environment

'We have about 18 different projects underway but we've achieved' only one value-based deal, Pfizer CEO Ian Read says. 'The risks and incentives have to be with the providers. … That's how you get the best health care.'

Pricing Strategies Market Access
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