March 13 Policy Watch: FDA streamlines its process for approving biosimilar drugs - C&EN

FDA streamlines its requirements for biosimilar drug approvals

The US Food and Drug Agency announced on March 9 new guidelines for testing biosimilar products, biologic drugs that are made by someone other than the inventor.

Whereas a generic-drug manufacturer can make exactly the same active pharmaceutical ingredient as that of an approved drug after an inventor’s patent expires, biological drugs’ size and complexity make exact replication more difficult. Biosimilarity is a regulatory solution that lets generic manufacturers prove their therapies work the same way as approved drugs without requiring a chemically identical product.

Under the new guidance, the FDA says it is open to considering data from clinical studies of how a biosimilar drug candidate is metabolized, even if the study compares the drug candidate with a product that is not licensed in the US, as long as the foreign and US products are comparable. This follows another change in testing requirements from October 2025, when the agency announced that chemical analysis could replace clinical studies in some parts of a biosimilar application.

In a press release, the agency says the latest change could cut about $20 million from the cost of developing a biosimilar drug, potentially lowering the end price for consumers. The Association for Accessible Medicine, a trade group for generic drug manufacturers, notes in a statement praising the new guidelines that the vast majority of drugs set to come off patent in the next decade do not have a biosimilar in development.

The guidance is a draft, and the agency is accepting comments through May 11.

—Laurel Oldach

FDA creates a new adverse-events database for all regulated products

The US Food and Drug Administration has launched a new data platform, the Adverse Event Monitoring System (AEMS), that will combine adverse-event reports for all the products the agency oversees and replace what were previously seven separate databases for vaccines, drugs and biologics, medical devices, cosmetics, human foods and dietary supplements, tobacco and nicotine products, and animal drugs and animal foods.

Adverse events are typically unanticipated side effects but can include “any undesirable experience” associated with using a product.

The new unified system, announced in a March 11 press release, is also expected to start publishing reports submitted by manufacturers, health-care workers, and consumers in real time by the end of May. Reports will not be vetted before being published, and the system comes with a disclaimer that they “may contain incomplete, inaccurate, untimely, and/or unverified information.” The FDA processes approximately 6 million adverse-event reports per year; the reports were previously published in quarterly batches.

One of the databases being replaced by AEMS, the Vaccine Adverse Event Reporting System (VAERS), has been cited in political debates over the safety of COVID-19 and other vaccines. Peter Marks, the former director of the Center for Biologics Evaluation and Research, resigned in April 2025 after refusing to give US Health and Human Services secretary Robert F. Kennedy Jr. access to edit data in VAERS, according to reporting by the Associated Press.

The new AEMS currently includes reports on vaccines, drugs and biologics, and cosmetics. Data on animal food and animal drug adverse events will be published within the next few weeks, the HHS press office said in an email. And in May, the FDA expects to add reports for medical devices, human foods and dietary supplements, and tobacco products.

—Delger Erdenesanaa

25 states ask to side with the EPA in endangerment finding lawsuit

The attorneys general of Kentucky, West Virginia, and 23 other states filed a motion (PDF) with a federal court on March 6 to join the lawsuit filed Feb. 18 by environmental, health, and youth climate groups challenging the US Environmental Protection Agency’s final rule to overturn the 2009 climate endangerment finding.

The group, made up of all but three of the Republican attorneys general in the US, filed a motion in the US Court of Appeals for the District of Columbia Circuit to intervene as respondents in the lawsuit, after the group’s involvement in a prior related case. In April 2024, Republican state attorneys general had asked the DC Circuit to review emission standards for light- and medium-duty trucks that the Joe Biden administration EPA had finalized earlier that year. The group had also submitted statements in support of overturning the endangerment finding before the EPA finalized the rule.

Emission standards raise the cost of maintaining and running state-owned vehicles, increase road and infrastructure expenses, and deprive states of revenue from fuel taxes, the attorneys general say in their March 6 motion.

The endangerment finding provides the scientific justification for regulating greenhouse gas emissions under the Clean Air Act. The EPA’s final rule to rescind the finding also includes removing some emission standards for passenger vehicles.

In the motion to join the case, the attorneys general also brought up a question that could potentially extend beyond this particular lawsuit. “The Final Rule raises fundamental questions about how climate-related matters should be addressed—whether through federal administrative agencies, Congress, the States, or other repositories of power,” the filing says.

Two other groups have filed lawsuits challenging the EPA’s endangerment finding action. The Zero Emission Transportation Association filed a lawsuit on Feb. 23, and the Metropolitan Congregations United for St. Louis and the Missouri Coalition for the Environment filed separately on Feb. 27. According to court records, all four suits have been combined into one case.

—Leigh Krietsch Boerner