On March 8, a Senate committee will hold initial hearings on legislation that would establish a process for the U.S. Food and Drug Administration to approve biogenerics (generic versions of biologic drugs known as biosimilars).

On average, the FDA approves one new generic version of a conventional (small molecule-type) drug per day but it lacks the authority (it says) to approve biogenerics. Basically, the FDA has taken the position that approval of follow-on biologics are too complex to regulate under current rules. The Senate wants to make a path for the eventual approval process.

Representatives Waxman, Emerson, and Pallone, along with Senators Schumer and Clinton, have re-introduced H.R. 1038, the “Access to Life-Saving Medicine Act,” which will establish a process through which the FDA will be able to approve generic biologics or biopharmaceuticals. However, expect a continuance of the brand name companies trumpeting safety concerns while generic companies cry protectionism.

In summary, H.R. 1038 would amend section 351 of the Public Health Service (PHS) Act to authorize the Secretary of HHS to approve abbreviated applications for biological products that are “comparable” to previously approved (reference) biological products.  In addition, an application for a comparable biological product must demonstrate that there are no clinically meaningful differences between the two products with respect to safety or effectiveness.  The application must also show that the new product and the reference product contain highly similar “principal molecular structural features” and the same mechanism(s) of action, if known.

While some type of biogeneric process is likely to happen, it won’t be soon and it could add millions to the cost of developing generic biologics in the end.  In comparison, European regulators reviewing biogeneric applications have required companies to conduct a series of analytical studies, preclinical studies, and clinical trials comparing its product to branded versions to ensure safety. Don’t look for legislation that will skirt the extra layers of safety checks.

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