This is the fourth remark associated to the pharmaceutical trade the FTC has submitted to numerous businesses because the starting of 2024, and a part of a broader effort by the FTC to prioritize “safeguarding fair competition and rooting out unlawful business practices in health care markets.”[1]

FTC says FDA’s Draft Guidance on interchangeability will improve competition in biologic marketplaces

Under the Public Health Service Act, the usual for interchangeability is {that a} biosimilar “can be expected to produce the same clinical result as the reference product in any given patient.”[2] For a product that’s administered greater than as soon as to a affected person, which means that the “risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.”[3]

A key side of the Draft Guidance[4] is that FDA not recommends that information from a switching examine be submitted to assist a request for an FDA dedication of interchangeability for a proposed biosimilar product.[5] This is a reversal from the 2019 Interchangeability Guidance, [6] which beneficial that requests for an interchangeability discovering embody switching examine information to, amongst different issues, deal with “any immunogenicity risk associated with switching or alternating between the reference product and the proposed interchangeable biosimilar.”[7] The Draft Guidance as an alternative says an applicant “may choose to provide an assessment of why the comparative analytical and clinical data provided” assist a exhibiting that the statutory customary has been met.[8] The Draft Guidance is the newest motion that’s half of a bigger latest development in efforts by FDA, different businesses and Congress aimed toward “flattening” the regulatory pathway for biosimilars to take away the excellence between non-interchangeable and interchangeable biosimilars, as mentioned in a previous Hogan Lovells alert.

The FTC remark letter[9] expresses assist for eliminating the advice to submit proof from a switching examine, as a result of “[c]linical switching studies can be time-consuming and expensive” and “[r]elying on clinical switching studies to establish interchangeability has likely contributed to marketplace confusion about biosimilars.”[10] For that purpose, the FTC says, the Draft Guidance “would likely have a positive impact on the number of biosimilars designated as interchangeable and the uptake of biosimilar products in general by reducing barriers to entry and increasing competition in the biologic marketplaces.”[11] In that regard, the FTC says the Draft Guidance would cut back the price of exhibiting that switching from a reference biologic to a biosimilar is secure and efficient, simplify the approval course of, and “help to dispel the false impression of separate safety and efficacy standards for interchangeables and other biosimilars.”[12]

FTC remark letter a part of ongoing company effort to goal anticompetitive conduct in pharmaceutical markets

The FTC locations this remark in the context of the company’s “long history of addressing illegal conduct that interferes with competitive and robust marketplaces and biosimilar products.”[13] Consistent with that view, that is simply the newest in a sequence of feedback the FTC has lately submitted to numerous businesses associated to numerous pharmaceutical trade subjects, together with these this 12 months:

• March-in Rights. On February 6, the FTC submitted a comment in assist of the National Institute of Standards and Technology (NIST) Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights.[14] The NIST guidance opinions elements an company could contemplate when deciding whether or not to train march-in rights, offering a framework to information decision-making about whether or not to intervene and train march-in rights.[15] The FTC’s remark expresses assist for NIST’s “expansive and flexible approach to march-in rights,” and particularly supports “the exercise of march-in rights where prices unreasonably limit the public’s access to drugs protected by federally funded patents.”[16]

• Patent Settlements. On June 18, the FTC submitted a comment in assist of a U.S. Patent and Trademark Office (USPTO) discover of proposed rulemaking (NPRM) that may require events to file with the USPTO all pre-institution patent settlement agreements,[17] together with collateral agreements. The FTC remark says the proposal would “enhance the FTC’s ability to monitor anticompetitive conduct related to patent settlements,” particularly with respect to settlement agreements between pharmaceutical producers. According to the FTC, such agreements “can raise antitrust concerns where they include reverse payments that keep drug prices high by impeding competition from lower-cost generic drugs.”[18]

• Patent Thickets. On July 9 the FTC submitted a comment in assist of a USPTO NPRM on “Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.” The remark acknowledges the necessity to “address the harmful exploitation of terminal disclaimers,” and asserts that the usage of terminal disclaimers “linking similar patent claims can exacerbate the exclusionary impact of patent thickets by forcing potential market entrants to incur the high cost of challenging multiple duplicative patents.”[19]

Each of the FTC’s feedback reiterates the FTC’s dedication to concentrating on anticompetitive conduct that may lead to elevated prescription drug costs and cut back innovation.[20] More particularly:

• Two of the FTC’s remark letters notice that the FTC has “taken aim” at model corporations/patent holders which may be “engaged in other unfair methods of competition, including sham patent litigation, anticompetitive loyalty programs that impede generic entry, and product hopping schemes.”[21]

• Three of the feedback spotlight the FTC’s ongoing efforts to dispute “improper” Orange Book patent listings that the company argues can hurt drug competition and represent a violation of the Sherman Act.[22]

• Two of the FTC’s feedback describe the FTC’s 6(b) examine of Pharmacy Benefit Managers (PBMs),[23] which targeted on inspecting the “impact of PBM business practices on prescription drug access and affordability and to advise policymakers on industry reforms.”[24]

The remark letter on the FDA Draft Guidance says the FTC’s July 2024 Interim Staff Report on PBMs “identified conduct by other market participants that can inhibit robust competition in generic and biologic marketplaces.”[25]

Takeaways

President Biden’s 2021 Executive Order on Promoting Competition in the American Economy directed federal businesses to deal with, amongst different issues, “unfair anticompetitive conduct or agreements in the prescription drug industries.” Under the management of FTC Chair Lina Khan, the FTC has prioritized selling competition in the well being care trade, with a focus on decreasing prices of prescribed drugs. The latest FTC feedback submitted in assist of varied U.S. authorities company initiatives in the pharmaceutical markets spotlight the continued efforts by the FTC to goal purportedly anticompetitive conduct in this house, and shed mild on the company’s competition priorities in the well being care sector extra broadly.