Biosimilars Battles Heat Up

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FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.

With the rise in industry programs for developing biosimilars, tensions are high as innovator firms back strategies that appear designed to delay competition. Key regulatory issues under review: testing requirements to document interchangeability; product naming to distinguish biosimilars from reference drugs and limit prescribing; and suggestions that switching from one interchangeable therapy to another raises additional safety concerns. 

Biotech exclusivity issues, moreover, recently emerged as a point of debate in the proposed US-Mexico trade pact updating the North American Free Trade Agreement (NAFTA). The Trump administration has included a provision that provides 10 years’ data protection for new biologics-an increase from the five-to-eight years of exclusivity allowed by Canada and Mexico. The Obama administration previously sought to negotiate a five-year exclusivity limit in the Trans-Pacific Partnership trade treaty, but met strong opposition from innovator firms, which have pressed for extending exclusivity to 12 years for biologics.

In addition, Pfizer recently filed a citizen petition with FDA seeking agency action to halt “misinformation” on biosimilar safety and use from reference product manufacturers. Pfizer cited false and misleading statements from innovators that suggest biosimilars are not as safe or effective as brands and have slowed prescribing and uptake of the new competitors. The petition asks FDA to issue guidance to prevent such violative actions.

FDA hears comments

These and other prominent regulatory, legal, and research issues were addressed by representatives of innovator firms and biosimilar makers, as well as patient advocates, payers and providers, at a recent FDA public hearing on competition and innovation in the biological products marketplace.  FDA sponsored the session to further advance its proposed Biosimilar Action Plan and expects to receive more extensive formal comments from stakeholders by Sept. 21, 2018. Although FDA has approved a dozen biosimilar products, only four are available to patients due largely to patent and competitive issues that block market access. 

Interchangeability was a key topic at the meeting, as brands urged “robust standards” for documenting this more similar status, including numerous switching studies that use only FDA-approved refence products as comparators. Biosimilar makers seek more leeway to submit data from clinical trials of similar products approved in the Europe and other industrial countries. A number of patient advocates backed the innovators’ stance, emphasizing the importance of produce safety and equivalence over potential cost savings. 


The need for distinct names and labeling of biosimilars vs. brands also was supported by innovators and some patient groups as important for avoiding confusion in tracking adverse events and post-marketing developments. A related issue is the use of individual billing codes for biosimilars as a way to discourage biosimilar coverage and reimbursement. 

An emerging issue is the claim by brands that switching patients to biosimilars may generate added costs. A recent study funded by AbbVie documents high expenditures for testing and doctor visits to ensure that shifting patients with autoimmune conditions to a similar therapy is safe and appropriate.

Less contentious were proposals to expand and revise FDA’s Purple Book listings of patent and exclusivity information on new biologics to facilitate biosimilar development. Biosimilar makers also sought a clearer, more seamless process for adding indications to approved products, and urged more scrutiny of coverage and rebate practices by health plans and payers.

But biosimilar makers continued to protest actions by innovators that block access to reference products needed for new drug testing, a heated issue for generics makers in all areas. FDA has objected strongly to brands “gaming” agency rules designed to ensure safe use and distribution of more high-risk therapies to block potential competitors from legitimate access to these products. 

This issue may be addressed by Congress, which is considering legislation to curb roadblocks erected by brands to supplies needed for bioequivalence testing and clinical trials. Additional measures would require all parties to report to the Federal Trade Commission (FTC) any “pay-for-delay” agreements designed to postpone when a new competitive product comes to market.