As promised last month, Anna Eshoo, a Democrat from California - specifically, the region where many biotechs and venture capitalists are based - has now introduced legislation that would create a so-called pathway for FDA approval while offering brand-name companies 12 years of exclusivity, plus an extra two years for a medically significant innovation. That adds up to, yes, 14 years. (This is the bill and this is the summary).

Not surprisingly, the BIO trade group was ecstatic in its praise for Eshoo and Joe Barton, a Texas Republican who joined her in sponsoring the bill, which calls for studies to demonstrate safety and efficacy; requires the FDA to create a mechanism to determine whether products are interchangeable and also requires the agency to issue guidances for biosimilar approvals.

“Some special interests publicly say they want to delay follow-ons legislation until next year or beyond,” says BIO ceo Jim Greenwood in a statement. “We urge Congress to pass the right bill as soon as possible. It is time all parties work together to place patient needs before political gamesmanship. The time is now to pass a pro-patient, pro-innovation, pro-science follow-on biologics bill.”

Conversely, the Generic Pharmaceutical Association was distressed and argued the lengthy exclusivity provision will deny patients access to lower-cost meds for years. “‘The Pathway for Biosimilars Act’ is a pathway to the wrong destination for patients in need of safe and affordable biogenerics. This new bill, at best, is a disappointing distraction that does nothing to advance legislation. At worst, it’s a step backwards that puts brand company profits before patient needs,” says GPHA ceo Kathleen Jaeger, in a statement. “For a pathway to work, it must ensure patient access. Unfortunately, this new proposal creates a pathway filled with needless roadblocks to access.