In the third part of our FDA: Drug & Device Team’s series on biological products regulation, we investigate how to qualify for reference product exclusivity (RPE) under the Biologics Price Competition ...

The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, ...

Pam Marrone, co-founder of Invasive Species Corporation, and previous founder of two additional biological businesses, shared her key takeaways with certified crop advisers during a recent webinar ...

One segment of biological products presents a specific opportunity for ag retailers. Several companies have introduced biological technology formulated to blend with a traditional dry bulk fertilizer.

Once the active ingredient is defined, an Applicant must select which patent, or patents, to put forward for extension. The statute permits only one PTE per regulatory review period, so the choice is ...

In the second part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss the regulatory pathways for biological products under Section 351 of the Public Health Service ...

Biologics are complex medications produced through biological processes or from living organisms such as proteins and genes. Biosimilars are what they sound like — similar to, but not the same as, an ...

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 ...

The Biologics Price Competition and Innovation Act of (BPCI Act) of 2009 granted responsibility to the FDA for review and approval of a new class of pharmaceuticals referred to as “Biosimilars.” (1) ...

This article originally appeared on PolitiFact. If you watch TV and don't mute ads, you've probably heard of a few biologics. They're drugs such as Humira for arthritis and Trulicity for Type 2 ...