Bringing Biosimilars to Market

The U.S. Food and Drug Administration (FDA) has issued draft guidance on the development of “biosimilars” – generic versions of biologics. Biosimilars are essentially more affordable versions of expensive and complex medications made from biological matter. This guidance will assist the Life Sciences industry, specifically Biotech companies, in developing these types of beneficial products in the U.S.

Traditional pharmaceutical drugs are small molecule, chemical- based, and relatively simple to manufacture. Biologics, on the other hand, are large molecule, protein-based, and rather difficult to manufacture. Biologics have had a profound impact on many medical fields, including rheumatology and oncology. In fact, they are the biggest-selling medicines on the market today. In 2010, seven out of the top 20 selling drugs in the U.S. were biologics, according to Morgan Stanley Research. These drugs have added major therapeutic options for the treatment of many diseases, including some for which no effective therapies were available, and others where previously existing therapies were clearly inadequate.

Enabling companies to manufacture generics versions of these drugs is a huge step in the right direction for the Biotech industry. “Instead of starting from scratch, these companies will be starting in the middle of the process,” said Dr. Rachel Sherman, FDA associate director for medical policy. And there is a huge market for these types of medications. According to Global Industry Analysts, the global market for biosimilars is forecast to reach $4.8 billion by the year 2015.

Clarkston explores this issue within its Insights paper Biopharmaceutical Generics: A Complicated Issue. Check out this paper to read more about how pharmaceutical industry can work to address the issues surrounding getting biosimilars to market.