The Biologics Price Competition and Innovation (BPCI) Act of 2009 establishes an abbreviated approval pathway for biologic drugs in the United States that are demonstrated to be highly similar (biosimilar) to or interchangeable with biological products licensed by the US Food and Drug Administration (FDA). BPCI was part of the Patient Protection and Affordable Care Act (Act) that was signed into law on 23 March 2010 (1). As the name of the umbrella legislation implies, the legislative…
Biosimilars
Nomenclature of New Biosimilars Will Be Highly Controversial
Biopharmaceuticals, including products approved as biosimilars, must be clearly defined, identified, and named to ensure accuracy in writing and filling prescriptions (1,2,3,4). The US biosimilars law enacted last year enables the Food and Drug Administration (FDA) to approve abbreviated biosimilar biologics license applications (bBLAs) or 351(k) filings based largely on their sponsors proving structural, composition, and clinical similarities with an approved biologic (reference product), much like generic drug approvals (5). The agency has yet to disclose how it will implement…
The New US Biosimilar Legislation, One Year Later
About a year ago, President Obama signed into law the highly publicized health care reform bill known as the Patient Protection and Affordable Care Act. This legislation included the new Biologics Price Competition and Innovation Act of 2009 (now a “biosimilar statuteâ€). Before enactment of that biosimilar statute on 23 March 2010, no “abbreviated†regulatory approval system existed in the United States for biologics — unlike Europe, which has had a system since 2005, and unlike US generic…
Review, Approval, and Marketing of Biosimilars in the United States
Development, testing, review, approval, and marketing of biosimilar drugs in the United States presents unique safety and regulatory challenges (1). By contrast with traditional small-molecule drugs, biologics derive from sources such as genetically engineered cell lines, plasma, and tissue specimens (2,3). Patents on first-generation biologics approved and marketed in the United States have begun to expire, thereby opening the market to less-expensive “generic†versions. The complexity of biologic drugs and the specificity of their source materials, however, make…
Review, Approval, and Marketing of Biosimilars in the United States
During the past 30 years, advances in medicine and pharmaceutical research generated a new class of drugs called biologics. These drugs are complex proteins, carbohydrates, or other large molecules derived from biological sources (1). By contrast with more traditional pharmaceuticals (small-molecule drugs), biologics are not synthesized chemically from less complex components, but rather are derived from or manufactured using living organisms or extracted tissue (2) Biologics make up a small but significant percentage of the overall pharmaceutical market.…
Throwing a Flag at Biosimilars
PHOTO COURTESY OF ROGER LUNDBLAD (PICTURED). When I officiated at high school (US) football, I learned a lot from the experience. Contrary to popular opinion, there are rule books referees study. However, although the rule book is modest in size, the case book for interpretations is large. This brings me to the topic of generic or follow-on biologicals and biosimilar products for which there will be rules, and the interpretations will be many. Continuing with the US football analogy, the…