The Biotechnology Industry Organization's point of view

Jim Greenwood

Even with the dynamic evolution of our industry in recent years, we have our work cut out for us: we need to ensure that all Americans have access to these life-enhancing and life-saving medicines.

Biologics are complex therapies developed from living cells and organisms. The slightest change in manufacturing processes can impact the safety, purity, and effectiveness of a biotech medicine. As the US Food and Drug Administration has recognized, these drugs are so molecularly complex that current science does not allow for an exact copy to be made.

The Biotechnology Industry Organization (BIO) supports the Pathway for Biosimilars Act (H.R. 1548), which was introduced by US Reps. Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX) in March and has more than 55 cosponsors. This bipartisan legislation lays out an effective, reasonable, and safe pathway to biosimilars and provides patients with the right balance between innovation and competition. This legislation requires clinical data while providing discretion for FDA to waive the requirement on a case-by-case basis. Immunogenicity data, which is necessary to avoid putting patients at risk of adverse effects from immune reactions, may only be waived after the issuance of product-specific guidance. The bill recognizes that switching products could put patients at risk of severe immunogenic responses and has high standards for interchangeability.

The Pathway for Biosimilars Act provides fair, responsible incentives for continued biomedical research that establish parity with the outcomes of the Hatch–Waxman regime developed for traditional pharmaceuticals. Innovator biologics would receive 12 years of data exclusivity (the period during which FDA could not rely on innovators' data to approve biosimilars) plus two additional years if the US Secretary of Health and Human Services approves a new indication that offers a significant clinical benefit and an additional six months for pediatric studies (if requested by the Secretary). This is consistent with the 13.5-year period during which the average traditional pharmaceutical is on the market without generic competition.

Fast Facts: The Hatch–Waxman Act

The Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427), which was introduced by US Reps. Henry Waxman (D-CA), Frank Pallone (D-NJ), and Nathan Deal (R-A), and its Senate companion (S. 726), introduced by US Senators Chuck Schumer (D-NY), Sherrod Brown (D-OH), Susan Collins (R-ME), and Mel Martinez (R-FL), provide a far less balanced approach to biosimilars. Neither bill had attracted more than a handful of cosponsors as of mid-April.

H.R. 1427 shortcuts scientific requirements needed to ensure patient safety and creates an imbalanced system that could chill investment in research focused on discovering new treatments and cures for devastating diseases. The bill does not require clinical data or immunogenicity testing.