Pharmacy Times Recaps Lanton Law's NASP Presentation on the FDA Biosimilars Action Plan

Pharmacy Times did a recap of our National Association of Specialty Pharmacy presentation on the FDA Biosimilars Action Plan, during NASP’s Annual Meeting this fall. The original story from Pharmacy Times can be found here. We have provided the article below in case you have trouble accessing the story. 

During the 2019 National Association of Specialty Pharmacy Annual Meeting and Expo, Ron Lanton III, Esq, reviewed the FDA Biosimilars Action Plan, its implications for the biosimilar marketplace, recent legislation set to influence the biosimilar pathway and drug accessibility, and the future of the biosimilar market.

Lanton began his presentation referencing the Biologics Price Competition and Innovation Act, which was enacted with the intent to balance innovation and consumer interest via an abbreviated approval pathway for biologic drugs that are biosimilar to or interchangeable with FDA-approved medications.

The FDA has since made substantial progress toward the scientific and regulatory policies needed to facilitate the abbreviated pathway. It established the Therapeutic Biologics and Biosimilars Staff under the Center for Drug Evaluation and Research, which supports consistent review of policy development for all biosimilars and interchangeable products, Lanton said. The agency also created the Biosimilar Product Development Program to facilitate the rapid development of biosimilar and interchangeable products. Finally, it has prioritized efforts to share regulatory information of stakeholders by publishing policies and documents on exclusivity.

Lanton noted the FDA Biosimilars Action Plan was released to allow the federal agency to manage the review and licensure pathway to facilitate biosimilar legislation; modernize policies that govern the development of biosimilars to make the process more efficient; educate clinicians, payers, and patients regarding biosimilar products and the rigorous evaluations that they go through; and modernize regulatory policies to accommodate new scientific tools that enable comparison between biosimilars and reference products, which may reduce the need for clinical studies.

The Biosimilars Action Plan also calls for the development of an application review templated for 351(k) biological licensing indications, improving coordination and supporting activities in the biosimilar/interchangeable process, accelerating the response time to determine the appropriate stakeholders, and increasing stakeholder communication, Lanton said.

The FDA said these actions and the revised guidelines are meant to prevent companies from blocking new biosimilars from entering the market and to stop manufacturers of reference products from manipulating the exclusivity provision to fend off biosimilar entry to the marketplace.

According to Lanton, the FDA is also going to issue a notice of how, if requested, it would go about trial protocols of applicants to determine whether its new protocols give enough safety protections for biosimilars in term of strategy. In May 2019, the FDA released a document seeking to promote competition in the biologic development market by providing final guidelines for interchangeable biologics.

“The FDA is updating guidelines now to provide additional clarity to biosimilar applicants who seek approval for all conditions for use for which the reference product is licensed,” Lanton said during the presentation. “The agency is also developing a proposed rule on the interpretation of the definition of [biological product], which will provide additional clarity and predictability.” Lanton referenced the following Congressional bills in his presentation:

• The Creating and Restoring Equal Access to Equivalent Samples Act, still under consideration, seeks to speed the entry of lower-priced drugs into the market.

• The Biologic Patent Transparency Act codifies the FDA’s Purple Book as a single searchable list and requires additional information to be published in it.

• The Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 limits to 20 patents that can be claimed for a reference product sponsor and tries to stop the “patent thicket.”

• The Prescription Drug Pricing Reduction Act of 2019 has the sole purpose of lowering drug prices. It wants to require that prescription biosimilar and biologic manufacturers that don’t have a Medicaid drug rebate agreement to report average sale price information to the Health and Human Services Secretary, who will use that informmation to establish the payment rates.

“Given the relative newness of biosimilars, the FDA is taking a proactive role toward giving clinicians, patients, and payers information about biosimilars and interchangeable products,” Lanton said. “They are doing this by developing educational materials and videos, explaining the concepts that the agency can use. The FDA will continue to evaluate if these firms are using statutory or regulatory requirements to appropriately delay the approval of a biosimilar or interchangeable companion.”

In referencing the future of biosimilars, Lanton stated that by 2020, there will be 56 new products in clinical development and as much as $110 billion in savings to health systems in Europe and the United States. Furthermore, there will be a 30% reduction in price per treatment day compared with originator biologics.
 

What Will Happen to Biosimilars in the USMCA Agreement in 2020?

Back in August I started an analysis of how biosimilars will be impacted in the new United States-Mexico-Canada Agreement (USMCA). To refresh, in a follow up on a 2016 campaign promise to renegotiate the North American Free Trade Agreement (NAFTA), the Administration has been engaging Mexico and Canada in an effort to create and ratify the USMCA. 

One of the major points of contention in the negotiation centered on the exclusivity period of biologics. Biosimilar manufacturers raised concerns about the fact that the USMCA would award biologic manufacturers 10 years of market exclusivity. 

Fast forward to December 19, 2019 when the U.S. House of Representatives approved the USMCA with a bipartisan vote of 385-41. When it comes to biologics, the status quo remains as the exclusivity period continues to be 12 years. A provision that would have guaranteed 10 years of market exclusivity for biologic drugs was stripped out of a deal between Congress and the Administration. 

Senate Majority Leader McConnell (R-KY) stated that the U.S. Senate would consider the measure in early 2020. The reason for the delay according to the Senator is due to the looming impeachment trial for President Trump. Stay tuned for developments.

If your organization intends to either start or increase your utilization of biologic/biosimilar products or you are interested in understanding how to invest in these emerging products, contact us today. 

New Draft Importation Rule Released

A new pilot program that allows states to import from Canada and allow manufacturers to voluntarily import has been announced via a draft rule through HHS and the FDA. 

The program would give states and nonfederal government entities the ability to import from Canada by applying to the FDA. Higher priced drugs such as biologics are not included in the draft rule. Here are some of the main points: 

• The drugs must be approved in Canada. 

• It does not include, controls, biologics or intravenously injected drugs. 

• States can work with wholesalers and pharmacies to create an application.

Canadian officials have already stated that the plan is unlikely to work as Canada is only 2% of the global market versus 44% from the U.S. This means that Canada will not be able to meet demand. 

A separate program that would allow for drug company importation of its own products does not take into account rebates or the best-price rule. The program requires that the drugs go through a separate re-labeling and testing that will have an additional cost. Additional costs may either cancel out any savings or make the drugs more expensive. 

This rule is in response to several states such as Florida who have created legislation in 2019 to allow for the importation of drugs from Canada. 

For more information regarding importation in general click here. 

Here is a link to the proposed rule. 

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