There’s a new face in the crowded pharmaceutical marketplace – Samsung. The mobile technology juggernaut responsible for Galaxy smartphones is diversifying into the lucrative biosimilar pharmaceutical business.
Samsung already makes medical devices like portable CT scanners, ultrasound machines, and in-vitro diagnostic devices and has created its own Samsung Medical Center. Still, it could be argued that medical technology isn’t much of a stretch for a company that makes state-of-the-art consumer electronics.
Samsung Sets Sights on US Pharma Opportunities
However, Samsung’s subsidiary Bioepis is gunning for a whole different type of technology – biologic technology.
Unlike its Android flagship phones, Samsung isn’t interested in breaking new ground in the pharmaceutical arena. Instead, Bioepis is creating “biosimilars” of biologic medications that are already successful.
What’s the Difference Between Biologics & Drugs?
Biologic medications are very different from chemically synthesized drugs. They aren’t simply a group of chemicals stuffed into a pill. Instead, biologics are derived from human genes using genetically-engineered proteins and “manufactured” inside living systems like microorganisms or animal cells.
Since living systems can be highly sensitive, the FDA approves a “process” for biologic drugs rather than a chemical formula like it does with drugs.
Biosimilars vs. Generic Drugs
It’s nearly impossible to reverse-engineer biologics the way generics can be produced for brand-name drugs. Instead, a biosimilar is approved by the FDA if it is “highly similar to an FDA-approved biological product and has no clinically meaningful differences in terms of safety and effectiveness.”
Samsung Goes Up Against Pharma Giant J&J’s Remicade
Samsung has applied to the FDA for approval of its candidate SB2, a biosimilar of Johnson & Johnson’s biologic Remicade, which is an extremely successful biologic drug used to treat arthritis, Crohn’s disease, ulcerative colitis, and psoriasis. Remicade is one of the top five best-selling medications worldwide – with a total of $6.5 billion in sales last year.
ACA Encourages Biosimilars via FDA Fast-Tracking
The US Patient Protection and Affordable Care Act (also known as the Affordable Care Act or ACA) created an “abbreviated licensure pathway” for approval of biosimilars, creating a gold-rush of interest in pursuit of FDA approvals. If Samsung succeeds in getting SB2 approved by the FDA, it will work with Merck in the US for marketing and distribution.