For the biosimilar industry, serious progress was made in streamlining biosimilar development, but little was finalized, under the leadership of now-former FDA Commissioner Dr. Marty Makary.

With the resignation on May 12th of Marty Makary, MD, MPH, as FDA Commissioner, it is difficult to analyze his performance after a scant 13 months in office. For instance, the FDA suffered massive staff cuts under the auspices of Elon Musk’s DOGE and was forced to hire back many of the same people.

Meetings of FDA’s Advisory Committees have been few and far between. This essentially wiped out the public’s ability to comment directly to scientists at the time of their votes for recommending or denying a particular drug approval. In fact, several of the FDA Advisory Committees no longer meet at all; only four meetings were scheduled to occur this year through the end of this month.

A Legacy of Advancing Biosimilar Development?

The FDA under Dr. Makary seemed eager to move forward to streamline biosimilar development, but this has not yet resulted in finalized regulatory policy. It is true that under his watch, the FDA issued its draft guidance on the removal of the mandate for phase 3 trials in biosimilar development, but 7 months later, no finalized guidance has been issued. During this time, the FDA has seemingly implemented this rule in any case, and as reported earlier in 2026, several biosimilar manufacturers have acted upon it, by terminating active phase 3 investigations.

In addition, we still have no official policy that nullifies or overrides the infamous interchangeability designation, despite FDA’s expressed opinion that it should be applied to any approved biosimilar, and holding a workshop on the issue last September.

In March, a draft guidance was released on removing the need for bridging studies when non-US licensed reference products are used for pharmacokinetic studies. The timing of the finalized document (after a public comment period) is up in the air, and may be further delayed without an official FDA Commissioner in office.

At certain points, he seemed to embrace the chaos at HHS and at others he tried to tamp down fires caused by the administration. In the end, his decision to fight industry interests in their promotion of flavored E-cigarettes may have been his undoing. However, it seems unlikely that anyone can truly make a lasting impression at FDA after only 13 months.

Overall, a statement he made at last October’s GRx+Biosims meeting sums up his legacy: “I think that we can unite in this country by focusing around health.” It demonstrated either the impossible challenge he faced in the administration or extreme obliviousness regarding the serious attacks on US public health by his boss at Health and Human Services.

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.

At the twice-yearly meeting of the Academy of Managed Care Pharmacy (AMCP), the job of the Government and Regulatory Affairs group is to brief members and attendees on the latest federal and state developments that affect health plan, pharmacy benefit management, and pharmacy in general. Much of this activity intersects with the biosimilar industry, as the managed care pharmacy and biosimilars sectors are inextricably linked.

At last week’s 2026 annual AMCP meeting, it was a particularly weighty task for the Academy’s Adam Colborn, JD, and Geni Tunstall, JD, to track and make sense of the torrent of federal initiatives released since AMCP’s Fall meeting in 2025. Indeed, Mr. Colborn, Vice President, Government Affairs, characterized his job over the past six months as drinking from a fire hose.

In just the past four months, we’ve seen action from the White House on most favored nations (MFN) pricing in the form of GENEROUS, GUARD, and GLOBE demonstration programs and TrumpRx; and the Federal Trade Commission’s settlement with Express Scripts. To top it off, Congress passed the Consolidated Appropriations Act of 2026 (CAA), with its emphasis on PBM reform.

Reforms and Settlements

Waiting in the wings is 340B reform along with other FTC agreements with the big 3 PBMs, a court fight over the new Section 232 pharmaceutical tariffs, a proposed rule for PBM transparency by the Department of Labor, and the brand-new charter by HHS of the Advisory Committee on Immunization Practices.

Additionally, Mr. Colborn pointed out, brand new legislation has been introduced that goes after vertical integration in healthcare. The Break-up Big Medicine Act (Senate bill 3822) does not have a parallel bill in the House, so it has a lesser chance of enactment, but he believes if passed, “it would be hugely disruptive to the health care system.”

Because PBMs have already begun to evolve away from a reliance on the rebate model to sustain their bottom lines, the provisions of the CAA “may be less impactful than it might have been if enacted five or six years ago,” said Mr. Colborn.

Codifying Opaque MFN Agreements

Geni Tunstall, Associate Vice President of Regulatory Affairs, said that “so far, the Great Health Care Plan seems to be a little more than loose concepts rather than a coherent strategic initiative.” Indeed, one of the more ironic musings heard at the meeting was that the Trump plan was a little more than plans to install a defibrillator in the White House’s new ballroom. However, Ms. Tunstall remarked that other than a desire for Congress to codify the MFN arrangements to ensure the durability of pricing negotiations between the administration and the pharma companies, there seems to be little behind a greater health plan reform effort.

Under MFN, which is now subject to voluntary agreements with 16 manufacturers, there is little known about the negotiations themselves, said Ms. Tunstall, and perhaps the bigger question, “How will patients benefit from MFN models?”

Furthermore, there is a question as to whether the shorter-term contracting processes used in the MFN-based GLOBE and GUARD models will support the effectiveness of these 5-year demonstration projects.

What Happens Next for MFN?

At a separate session on MFP and MFN pricing, pharmacists speculated on the unintended consequences of the move towards MFN pricing. Lisa Kennedy, PhD, Chief Economist at Innopiphany, reminded the attendees that the European mechanism for determining pharmaceutical pricing for pharmaceuticals is unlike that for the US: not only do many EU countries rely on contract tenders or bidding processes, but several countries actually seek to rationalize drug pricing through a calculation of drug value (as the UK does with the National Institute for Clinical Effectiveness). This implies that simply pegging US prices to what Europeans pay would not be a long-term solution and would result in accelerated drug withdrawals from the market, delayed launches, or even approvals in the US but no intention to launch in this country.

International prices will inevitably rise as our prices fall, squeezing the manufacturer in the middle. We can also expect reduced price transparency, as companies tried to come to agreement with individual governments. And how tariffs play into existing MFN strategies or negotiations is anyone’s guess.

Deb Curry, PharmD, Chief Clinical Officer of Health Delegates, emphasized the role of transparency. Clinicians want to see the patient’s whole picture, but the impetus to go outside of the pharmacy benefit through direct to consumer purchasing challenges the industry’s ability to pull this information together. There are doubts, Sarah Rivera, PharmD, noted, that patients will spend hundreds of dollars on TrumpRx or any other DTC site for chronic medications, thus making the point moot.

Additional unintended consequences of both the MFN and MFP initiatives include an estimated 48% potential reduction in biopharma patents, with job losses in the pharma industry of 472,000 over a decade. With a narrow pricing corridor, drug companies may elect to delay launches, withdraw from certain markets with lower prices, and likely increase drug prices upon launch.

It is difficult to know whether the firehose spigot has been turned off for now or there are new poorly considered initiatives on the table. We do know that all of these will not work well in a well-timed sequence of events or concurrently to improve the health system. There’s chaos not coordination, and that seems to be the order of the day in this administration.

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.