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July 2023 Newsletter

Safe Biologics

ASBM & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient Access On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines.

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December 2023 Newsletter

Safe Biologics

The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted.

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January 2024 Newsletter

Safe Biologics

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability.

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US legislative update: takeaways for European pharma

European Pharmaceutical Review

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars.

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Three strategies for managing loss of exclusivity successfully

pharmaphorum

Drug prices to plummet in wave of expiring patents”. Price decay after loss of brand exclusivity”. These are just three headlines that come up when you Google “drug patent expiry”. Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. “Patent losses could sink Allergan”.

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August 2023 Newsletter

Safe Biologics

ASBM Statement on Announcement of Medicare Drug Price-Setting List On August 29th, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed into law last year.

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Patents: a necessary evil?

European Pharmaceutical Review

1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. 23 April 2013. Patents are often described as the ‘lifeblood’ of pharmaceutical companies.