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.
Forbes contributors publish independent expert analyses and insights. Joshua Cohen is a Boston-based writer who covers health policy. Biosimilars are gradually making inroads in the outpatient drug ...
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 ...
Advancements in biological production has increased adoption. In 10 years, biologicals have made big strides—going from $10 billion in sales in 2021 to an estimated $18 billion in 2026, according to ...
Today, the US Food and Drug Administration (FDA) released its long-awaited guidance establishing a naming convention for biologicals, including related and biosimilar products. With the passage of the ...
The US Food and Drug Administration (FDA) today released a new draft guidance document intended to explain how biological products approved under Section 351(a) of the Public Health Service Act (PHS ...
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 ...
The U.S. Food and Drug Administration’s (FDA) new draft guidance may reduce the cost and time to market for some applicants with biosimilar Biologic License Applications (BLAs). This draft guidance ...
An updated edition of the April 13, 2026, article. Genomics is the comprehensive study of genomes, the complete set of deoxyribonucleic acid (DNA) within an organism. Rapid scientific progress in this ...
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 ...
Please provide your email address to receive an email when new articles are posted on . Biologic therapy requires standardization for the treatment of musculoskeletal conditions. Surgeons must ...
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) ...