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Biogenerics Years Away from Market Pipeline


Biogenerics will not be taking the U.S. marketplace by storm any time soon. Approval of biogenerics is creating a rift between innovators and generic manufacturers and is putting data exclusivity and interchangeability to the test

Key Points

"It is frustrating for the generic manufacturers," says Steve Miller, MD, chief medical officer and vice president of specialty pharmacy for Express Scripts. "Once the innovator drug has lost patent, there are no pathways for the generic to hit the marketplace."

Mesfin Tegenu, president of PerformRx, a PBM headquartered in Philadelphia, predicts a two-year struggle to move the FDA generic-approval process forward for off-patent biologics, but more likely three to five years will be needed.

"Follow-on versions of FDA-approved biological products will be significantly more complicated to produce than the generic drugs approved under the process established by Hatch-Waxman," says Sheldon Bradshaw, co-chair of Hunton & Williams LLP's food and drug practice and former chief counsel of the FDA. "Depending on the particular framework established by Congress, the FDA will likely be required to issue detailed guidance documents before actually approving any [biogenerics]."

Approval of biogenerics is creating a rift between innovators and generic manufacturers and is putting data exclusivity and interchangeability to the test.


Interchangeability requires evidence that the generic product will produce the same clinical result as the brand product in any given patient and that it presents no additional risk in safety or efficacy if a patient switches between products. If a biogeneric is granted interchangeability status, it may be substituted for the brand product without requiring permission from a physician. The complexity of biologics makes it impossible to analyze them in a laboratory to the degree possible with chemical drugs.

Both Bradshaw and Tegenu agree that it is highly unlikely that biogenerics will be approved as equivalent to the original product without lengthy clinical trials.

In fact, David Williams, co-founder of consulting firm MedPharma, questions whether the drugs will be substitutable at the pharmacy.


A bill introduced by Reps. Henry Waxman (D-Calif.) and Frank Pallone (D-N.J.), and Sens. Charles Schumer (D-N.Y.) and Hillary Clinton (D-N.Y.) is strongly in favor of biogenerics. It establishes a rigorous, case-by-case scientific process for approving these products at the discretion of HHS. This legislation grants the first applicant for approval of an interchangeable biogeneric with a period of exclusive marketing.

Another bill introduced by Rep. Jay Inslee (D-Wash.) is highly supportive of the drug innovator and calls for a 14-year exclusivity period and for clinical trial requirements for non-identical products.

On the heels of these two bills is a compromise measure sponsored by Sens. Edward Kennedy (D-Mass.) and Clinton, which was cleared by the Senate; however, it ultimately failed to be attached to the Prescription Drug User Fee Act (PDUFA) reauthorization bill that was approved in September.

The measure provides incentives for the development of new biological products and interchangeable biogeneric products: 12 years of data exclusivity for the brand company, and one year of exclusivity for the first interchangeable biological product. Without a grandfather clause, however, some biologics approved in the 1990s could face competition almost immediately.

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