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FDA Issues Final Biosimilar Guidance

Pills and dollar bill

(Thomas Breher, Pixabay)

13 May 2019. The Food and Drug Administration issued its final guidance on regulating the interchangeability of so-called biosimilars with original biologic drugs. The agency posted the document Friday on its web site, in advance of its official publication tomorrow.

Biosimilars are engineered replacements for original branded biologic drugs, and not one-to-one chemical substitutes like generic drugs. As a result, biosimilars are more complex and must show they are interchangeable with the branded drugs they seek to replace. That interchangeability requirement is detailed in the Biologics Price Competition and Innovation Act of 2009, which was folded into the Patient Protection and Affordable Care Act, passed by Congress and signed by President Obama in 2010.

The new document aims to clarify issues raised by commenters on an earlier draft, with the goal of offering more treatment options for patients and potentially reducing costs of biologic drugs through competition. The guidance notes that for a biosimilar to be interchangeable, it must show the same clinical results as the original biologic in any patients, and for all approved conditions. In addition, biosimilars must show they can be substituted for original biologics or vice versa, with no diminished efficacy or risk to patients.

Acting FDA Commissioner Ned Sharpless points out in an agency statement that the new guidance may encourage more biosimilars for insulin, needed daily by people with diabetes. “There are currently no approved insulin products that can be substituted at the pharmacy level,” says Sharpless. He adds, however, that the Biologics Price Competition and Innovation Act makes it possible to now classify earlier-approved insulin and other biological compounds as biologics, and thus subject to competition from biosimilars. That aspect of the law goes into effect in March 2020.

The price of insulin has become a hot-button political issue. As reported in February by Science & Enterprise, and earlier by the Washington Post, a 10-milliliter vial of insulin with a list price of $21.00 in 1996, now sells for $275.00. A paper on insulin markets last year by American Diabetes Association shows a highly concentrated industry and complex supply chain. Today, only 3 insulin manufacturers serve the U.S. market: Eli Lilly & Co., Novo Nordisk, and Sanofi.

The report also indicates that insulin distribution follows a traditional manufacturer-wholesaler-retailer supply chain, but prices paid by consumers are significantly affected by negotiations with pharmacy benefit managers, or PBMs, and payers for health care services, including insurance companies, Medicare, and Medicaid. The report says PBMs exercise a strong influence on prices, since they administer drug benefits for some 266 million Americans, but just 3 of these companies — CVS Caremark, Express Scripts, and OptumRx — manage about 70 percent of all pharmacy claims.

Sharpless adds that the agency is particularly interested in feedback from people using insulin pumps and newer closed-loop systems that combine insulin pumps with blood-glucose monitors, who receive insulin injected directly under the skin into the blood steam as needed. He says these devices “raise unique scientific considerations that we should be considering when evaluating biosimilar or interchangeable insulin products.”

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