Comments and Letters to FDA in Response to Biosimilars Action Plan

The Association for Accessible Medicines (AAM) and Biosimilars Council submitted comments to FDA two weeks ago regarding “the biosimilars action plan and ways to facilitate competition” in the biosimilars industry. Collectively referred to in the comments as AAM, and the “sole association representing America’s generic pharmaceutical sector in the United States,” AAM voiced their concerns that the development of the biosimilar industry is “in jeopardy . . . largely [] due to tactics used by some originator biologic companies that abuse their dominant market position to create as many barriers as possible to biosimilar approval and uptake, for example: restricting access to samples needed for biosimilar development; establishing ‘patent thickets’ []; and sowing seeds of doubt regarding the safety and efficacy of FDA-approved biosimilars through misleading communication to prescribers and patients.

In response to an FDA notice published in the Federal Register on July 25, 2018, AAM sent written comments to address “how to facilitate greater availability of biosimilar and interchangeable products while retaining the balance between competition and innovation that Congress intended to achieve under the BPCI Act.” Some of the suggestions made by AAM and its members included, “[w]ork[ing] within HHS to advance incentives to ensure further market penetration and timely adoption of lower-priced, life-saving biosimilar medicines; [w]ork[ing] with the Patent and Trademark Office (PTO) to stem the issuance of non-innovative patents used to extend monopolies, and support[ing] the use of Inter-Partes Review; [c]ontinu[ing] to work to prevent the misuse of restricted access programs to block biosimilar development; and [a]ccelerat[ing] the education of physicians, patients and other key stakeholders regarding the safety and effectiveness of FDA-approved biosimilars.”

AAM also requested that FDA update the Purple Book to clarify which products don’t have exclusivity and reject “umbrella exclusivity” in the context of Reference Product (RP) exclusivity because of the differences between Hatch-Waxman and BPCIA in terms of the role of patents and non-patent exclusivity. AAM asserted that “these differences between the Hatch-Waxman Act and BPCIA indicate that Congress was interested in incentivizing the ‘first licensure’ of a new biological product but not subsequent product enhancements, including new indications.” Moreover, with respect to the “umbrella exclusivity” issue, AAM pointed to specific statutory language of the BPCIA that they believe “explicitly foreclose[s]” such a policy.

A cohort of 29 additional stakeholders also recognized the importance of advancing U.S. biosimilars. In a group letter to FDA, signed by leading health care policy and advocacy organizations, including American College of Physicians, CVS, Express Scripts, and the America’s Health Insurance Plans (AHIP), the stakeholders requested that the agency enhance the efficiency of FDA review of marketing applications for biosimilar and interchangeable products, provide additional scientific and regulatory clarity for biological products, and increase healthcare provider, patient, and payor understanding of biological products to “combat misinformation.”