Rise in Biosimilars & Generics

A biosimilar is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product, according to the FDA. In other words, biosimilars do not necessarily contain the same active ingredients as the reference product. In contrast, generic drugs do contain the same active ingredients as those of the brand name drugs. Biosimilars and generics are often cheaper than brand-name drugs, but are each regulated differently.
	The industry has seen a rise in biosimilar and generic drugs as decades-old patents begin to expire. But, according to PwC, pharma companies will not be focusing on developing new patented products in the next few years. The Brazilian, Russian, Indian and Chinese drug markets are each expected to spend about double the amount on generics compared to patented products.
Part of this rise is attributed to a growing demand for cheaper medicine. Generic versions of Lyrica, Advair and EpiPen all hit shelves this year, boasting reduced prices for patients with nerve pain, asthma and life-threatening allergic reactions, respectively. Over years of advocacy, the FDA published a new analysis showing greater competition among generic drug makers is associated with lower generic drug prices.

 

For 2020, PwC expects that nations experiencing rapid economic growth (Brazil, Russia, India and China, for example) will dominate the local generics scene.