GPhA Mediates Language For Biosimilar Legislation

The Generic Pharmaceutical Association has offered a compromise to existing legislation being lobbied by biotech companies on behalf of their biologic drugs whose patents are about to expire — an event that will lead to a flood of biosimilars in the U.S. pharmaceutical market. The new language has been accepted by both sides of the argument, The Wall Street Journal (WSJ) reports.

The WSJ is quick to point out that the FDA has still not approved a single biosimilar for clinical use in the U.S., and federal legislators are still ironing out the details of if and how two biologically-based drugs could be considered interchangeable. The FDA has only recently begun to accept biosimilar applications for consideration.

Nevertheless, many experts consider the shift to be inevitable, as many biosimilars are currently being marketed in Europe and Japan.

Reuters reports that 245 companies have biosimilar candidates in the works, all of which hope to tap a potentially $25 billion market when the biologic patents expire.

Ralph Neas, GPhA president, projects that if the 11 most likely biosimilars enter the market, patients stand to save $250 billion in ten years.

Jon Harris, managing director of Thomson Reuters Life Sciences, explains, “Rather than forgo the benefits of biologics, governments and payers are counting on biosimilars to dramatically change drug development and patient costs by reducing the price tag of important biologics and increasing access to life-saving drugs.”

In an effort to protect their investment for as long as they can, biotechs Amgen and Genentech have initiated a legislative effort on the state level (drug substitution is handled at the state level) to draft bills that would potentially make biosimilar substitution more difficult for doctors and pharmacies, WSJ reports.

Originally, the language of the law proposed required pharmacists to notify doctors when a biosimilar was substituted for a branded biologic. It was intended to impose a barrier to automatic substitution.

Neas remarked, “From our perspective, the legislative measures [proposed by biotechs] would have restricted patient access to these new medicines.”

Instead, the GPhA drafted new language that both sides could agree on and which would allow the legislation to proceed to each state with the same clear and consistent message with concessions made to both sides.

An Amgen spokesperson told WSJ, “The language adopted by the coalition has progressed by placing an appropriate emphasis on electronic technology to ensure accurate medical records, while creating a clear pathway for substitution of interchangeable biological products.”

Neas said, “GPhA will continue to work closely with our members and partners in the supply chain to further improve the legislation and ensure that barriers to automatic substitution are not enacted.”