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Boehringer Ingelheim Files Citizen Petition to Change FDA's BPCIA Interpretation


To spur more biosimilar development and reduce anticompetitive practices, the company argued the FDA could improve its interpretation of the term “strength” in the Biologics Price Competition and Innovation Act (BPCIA).

Boehringer Ingelheim (BI) said that it has filed a citizen petition asking the FDA to change its interpretation of a portion of the Biologics Price Competition and Innovation Act (BPCIA).

Citizen petitions are an avenue for companies and other interested parties to ask the FDA commissioner to change agency regulations or take administrative action.

The company requested that the FDA alter its interpretation of the term “strength” as used in section 351(k) of the Public Health Services Act, in regard to parenteral solutions, to mean “total drug content” without taking into account the concentration.

According to BI, the FDA’s current interpretation does not allow a biological product to receive licensing as a biosimilar or an interchangeable biosimilar if there are any variations in the volume of inactive drug content, even if the amount of active drug content is consistent with the reference product.

“By working closely with industry peers, payors, healthcare providers, and patient advocates, and engaging in a transparent and public discussion of the issues we have raised, Boehringer Ingelheim believes that correction of the interpretation by the FDA may increase access to more affordable biosimilar and interchangeable biological products approved via the 351(k) pathway,” said the company in a statement.

BI Identifies 4 Issues With FDA’s Current Interpretation

In the petition, BI gave 4 specific reasons that the interpretation should be changed. The first was that it conflicts with the clear meaning of “strength” that Congress adopted in 2009 when it passed the BPCIA.

Second, the company argued that the current interpretation permits reference drug sponsors to use minor concentration changes to prevent competition from biosimilar and interchangeable biological products.

“We believe the actions requested in this petition will benefit patients and the healthcare system, potentially leading to more robust biosimilar development and use, and reduce anti-competitive behavior within the biosimilars industry,” said BI.

Third, BI noted that the interpretation allows for parenteral solutions to be treated differently than other parenteral products, such as lyophilized powder used in treating pediatric patients who have a growth failure, without appropriate justification.

Lastly, BI contended that its suggestion for “strength” to mean “total drug content” without regard to concentration better promotes the goals of the BPCIA and that there are no opposing regulatory interests that outweigh the benefits that the change could bring.

Past Problems With Citizen Petitions

In the past, reference product manufacturers have taken advantage of citizen petitions to stall competition, using them to call on the agency to refrain from approving a generic or biosimilar product unless certain conditions are met.

In 2019, the FDA finalized industry guidance to prevent companies from using citizen petitions to delay market entry of competitive products.

In April 2019, HR 2387, a bipartisan bill intended to stop sham citizen petitions from disrupting the FDA’s approval process for generic drugs, was introduced into the House of Representatives. In November 2019, the House Energy and Commerce Subcommittee on Health voted to forward the bill to the full Energy and Commerce Committee.

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