FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone ...

Feldman and Schor explain that the patent dance is a complex process to determine which of a biologic manufacturer’s patents ...

Slashing drug imports could trigger widespread shortages, experts said, because of America’s dependence on Chinese- and Indian-made chemical ingredients, which form the critical building blocks of ...

From the creation of a regulatory pathway for biosimilars in the EU only three biologics experienced EU biosimilar competition until the launch of Remsima/Inflectra in 2013, and none have (as at ...

Additionally, the Department of Health and Human Services unveiled the framework for the Most Favored Nation drug pricing ...

There were also five new drugs referencing the ophthalmology drug Eylea (aflibercept) that gained FDA approval in 2024.

Autoimmune Disease Therapeutics Market projected for significant growth from 2025 to 2035, driven by biologics, innovation, and rising prevalence Global demand for autoimmune disease therapeutics is ...

Under the Medicare Drug Price Negotiation Program, the HHS secretary negotiates directly with manufacturers on the prices ...

Looking further ahead, NHS England envisages savings as a whole from biosimilars of some £400 - £500 million per year by 2021, if it can increase uptake of ‘best value biologic medicines’.

As healthcare systems worldwide shift toward personalized treatment, biopharmaceuticals are gaining momentum for their ability to target disease mechanisms at the molecular level. The rapid ...

In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar ... 13 directives related to that policy, with ...

FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers ...