The Nobel Prize in Medicine will never be awarded for excellence in the formulation and manufacture of biologic medicines. That’s understandable. Patients who need these medicines deserve the product ...

The FDA classified insulin as a biologic product Feb. 20, a move that opens the drug up to more competition, potentially lowering costs for patients who rely on it. The change allows drugmakers to ...

Recent amendments to the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), 1 titled the Patient Right to Know Drug Prices Act, 2 require parties to inform regulatory ...

Apogee Therapeutics (APGE) leverages IL-13 pathway optimization to enable less frequent dosing, targeting a leadership shift ...

The market for insulin and certain other biological products may change in the coming months and years, as a provision in Biologics Price Competition and Innovation Act (BPCIA) goes into effect on ...

Biosimilars are manufactured by different companies but have potency, safety, and efficacy very similar to previously approved reference biologics. Creation of a regulatory pathway for biosimilars was ...

Please provide your email address to receive an email when new articles are posted on . NASHVILLE, Tenn. — A presenter, here, suggested ways that orthopedic surgeons can avoid being scrutinized by the ...

Though biologic medications have improved the treatment landscape by providing the solution to many unmet medical needs, biologics cost much more than small-molecule chemical medications. Biosimilars ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

With seven biosimilars currently on the market and 18 biosimilars approved by the FDA as of April 2019, one question is sparking a lot of debate: What should the scientific, or nonproprietary, names ...