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“We will need to be science-based, we will need to be global and we will need to have a cost-effective infrastructure,” Wheeler told the more than 600 members at the meeting. “These are the measures that will predict long-term success. The promise is huge. By 2020, biologics, with a total of over $100 billion in annual sales, will have lost patent protection. Biologic drugs are clearly the growth area for the future.”
Unlike traditional chemical-based prescription drugs, biologic medicines are derived from living organisms, such as yeasts or bacteria. Biologic medicines are often the only treatments for many of the most severe diseases. However, their high price tag can keep them out of reach for many patients. As proven with chemical prescription drugs, competition from generics will be the most important factor in holding down the cost of biologic medicines.
“We are going to be facing a challenging market as we seek to launch our products in the U.S. and around the world,” Wheeler said. “The pressures on this market, in many ways, should work in our favor as we seek to drive lower-cost biologics into the market. The bottom line is that we need to be prepared to invest creatively to compete.”
By every account, competition from biosimilars in the biologic sector would save patients, insurers and the government billions of dollars each year in treatment costs. Even stakeholders on the brand side of this issue—namely BIO and PhRMA—recognize that competition will significantly reduce costs.
“This is one of the rare occasions where a multi-billion dollar market will be created in the next few years,” Wheeler added. “The FDA has created a flexible pathway and the starting gun has fired. Though the long-term market is predictable, we are facing a chaotic period as regulators and competitors move up the learning curve and the needed science is advanced. The opportunity to build a strong business in biosimilars…will depend on shedding the weight of legacy businesses and building an adaptable infrastructure that can flex with the regulatory pathways, evolve scientifically and execute commercially.”