It was just ten years ago when in the face of the AIDS pandemic, wealthier nations and big pharma agreed to give up patent rights and profits in order to provide developing nations with vital treatments. Generally, patents provide inventors with 20 years of exclusive sales, however, according to international law, countries may force companies to share those rights with competitors if it means protecting public health. Historically, however, the U.S. has been a strong advocate of protecting patents in international trade to protect domestic pharmaceutical industries and provide them with incentives for future innovations.
But now companies in China and India are announcing that they are on the verge of manufacturing cheaper copies of biological drugs used to treat cancer and diabetes. Unlike small-molecule pills, biotech medicines generally vaccines, proteins, and antibodies are much more difficult to produce and purify, requiring multiple specialized techniques.
A biotech product is more like a recipe, whereas a small molecule is like a single ingredient, such as salt. Salt is salt, but no two batches of a biologic will be identical, adds ACSH s Dr. Josh Bloom, since the methods of preparation and purification used must be pretty exact. Thus, generic biologics may well be less pure, which could render them less effective or even dangerous.