Game On: Medicare Will Parry Manufacturer Efforts To Sidestep Price Negotiation, Guidance Says

CMS will need to continue to be ‘savvy’ to strategies brand manufacturers already employ to shape the landscape for generic and biosimilar competition, policy expert says.

CMS Likely To Face Creative Efforts From Manufacturers • Source: Shutterstock

The Centers for Medicare and Medicaid Services will work to ensure that new generics and biosimilars that could disrupt or delay price negotiation for brands are not encumbered by distribution or sales limits dictated by the reference product manufacturer, the agency says in its initial guidance for the program.

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England’s NICE Wants Industry Involvement In HTA Sandbox Projects

 

Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.

Brazil Catches Up With International Standards on Viral Safety Evaluations For Biotech Products

 

The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.

Korea To Revise ‘Innovative Company’ Criteria Amid Calls From Foreign Industry

 
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South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.