Should the FDA’s ‘Purple Book’ of Biosimilar Products Be More Useful for Developers of Generics? (H.R. 1520)

What is H.R. 1520?

(Updated December 23, 2020)

This bill — the Purple Book Continuity Act of 2019 — would require that the FDA proactively determine the reference product exclusivity for each licensed biological product (or biosimilar) listed in the Purple Book. It also would direct the FDA to solicit public comments regarding the type of information that should be contained in the Purple Book and transmit a report to the Congress within three years after the date of enactment.

This bill would also impose a private-sector mandate requiring biological product manufacturers to provide the FDA with certain patent information when that information is shared with biosimilar product manufacturers.

Finally, this bill would specify that the Purple Book should be published to the FDA’s website and updated regularly.

Since the determination of reference product exclusivity is a complex, resource-intensive assessment for the FDA to make, it’s currently generally made only for reasons of regulatory necessity or because the license holder that submitted the application requested the determination.

The Purple Book currently specifies whether a biological product licensed and marketed under section 351(k) of the Public Health Service Act (PHS) has been determined by the FDA to be biosimilar to (or interchangeable with) the reference biological product. It also includes the date a biological product was licensed for marketing under 351(a) of the PHS Act and whether the FDA evaluated the biological product for reference product exclusivity. Information in the Purple Book is updated periodically by the FDA.

Argument in favor

Biosimilars are becoming increasingly important as a mode of treatment for a range of conditions. However, branded products can be expensive — so supporting generic biosimilar development through resources such as the Purple Book is important.

Argument opposed

While lowering drug prices for consumers through generics, including for biosimilar medical products, this bill could stifle innovation by empowering generic manufacturers relative to the initial developer.

Impact

Biosimilar pharmaceutical drug companies; biosimilar drugs; biosimilar drug development; FDA; and the Purple Book.

Cost of H.R. 1520

The CBO estimates that implementing this bill would cost the FDA about $3 million over the 2020-2024 period to hire about five full-time employees to cover the increased workload to comply with the listing and reporting requirements in this bill.

Additional Info

In-Depth: Rep. Anna Eshoo (D-CA) introduced this bill to encourage generic biosimilar product development by making necessary information available in the Purple Book. In opening remarks when this bill, along with five other drugs addressing various delays to drug development and market entry, was considered by the House Energy and Commerce Committee, Committee Chairman Rep. Frank Pallone (D-NJ) said:

"Two of the bills we will be discussing — the Orange Book Transparency Act of 2019 introduced by Rep. Kelly, and the Purple Book Continuity Act of 2019 introduced by Chairwoman Eshoo — would help to increase accuracy and transparency of the two databases that guide development decisions for generic and biosimilar manufacturers. These bills would help generics overcome the barrier of patent listing… These are all commonsense solutions that will remove unnecessary barriers to competition. These bills are a strong first step in making prescription drugs more affordable and providing real relief to hardworking Americans that are being price gouged at the pharmacy counter."

In testimony to the House Energy and Commerce Health Subcommittee, Association for Accessible Medicines (AAM) president and CEO Chester “Chip” Davis, Jr. expressed his organization’s support for this bill:

"AAM supports the Orange Book Transparency Act and the Purple Book Continuity Act, and recommends additional transparency and disclosure requirements consistent with our comment letter to HHS be included… Efforts to ensure patients are able to fully realize the savings available from generic and biosimilar medicines on the market today combined with Congressional action to advance policies that increase competition is the ultimate equation to achieving the shared goal of enhancing patient access to more affordable generic and biosimilar medicines."

America’s Health Insurance Plans (AHIP) expressed its support for this bill in testimony to the House Energy and Commerce Committee Subcommittee on Health on March 13, 2019:

“By including more information about approved biological products, [this bill] can help stakeholders have access to more timely and updated information on biologics and biosimilars via enhancements to the Purple Book. Moreover, making available such information—including critical information related to biologic patents and bioequivalence studies—can help biosimilar developers in bringing their products to market and increasing the availability of more affordable treatment options for patients.”

In a House Energy and Commerce hearing on this and other bills, including the Orange Book Transparency Act of 2019, Republican leadership raised the concern that lowering drug costs had become a one-sided issue, as Democrats kept them in the dark on bill language and witness attendance. Republicans contended that many of the bills before the subcommittee lacked bipartisan support due to short notice, and that some of the proposed legislation even made complex changes to the FDA without the agency’s input or attendance at the hearing. Republicans and several witnesses expressed concern that legislation discussed would stifle innovation. Witnesses testified that settlements between branded and generic manufacturers get generic products to market more quickly than requiring parties to pursue the full litigation process. In response, Democrats continuously stressed than more generic competition was needed to immediately lower prices, and many encouraged greater biosimilar market entry and uptake.

This bill passed the House Energy and Commerce Committee with the support of 12 bipartisan cosponsors, including 10 Democrats and two Republicans.

Of Note: Biosimilar products are biological products that are highly similar to the reference product, notwithstanding minor differences in clinically inactive components. There are no clinically meaningful differences between biological products and reference products in terms of safety, purity, and potency of the product.

Media:

• House Energy & Commerce Committee
  
• CBO Cost Estimate
  
• The Campaign for Sustainable Rx Pricing (CSRxP) (In Favor)
  
• America’s Health Insurance Plans (AHIP) (In Favor)
  
• Ernst & Young Tax News Update
  
• Policy & Medicine
  
• Purple Book
  
• Countable (Related Bill)