The updated policy, “Generic and Biosimilar Prescribing in Children and Adolescents,” recognizes the role generic drugs play as part of a patient’s overall health plan as a majority of prescriptions written in the United States are for these drugs.

May 26, 2026 - ITASCA, IL— The American Academy of Pediatrics has announced an updated policy statement to recognize the safety and effectiveness of generic drugs and explore the use of bio-similars in the pediatric field.

The policy statement, “Generic and Biosimilar Prescribing in Children and Adolescents,” and its accompanying technical report explain that in previous years, pediatricians were unsure if generic drugs were as safe or effective as brand-name medications. Recommendations formerly called for prescribing generic medications only with a clinician’s specific approval.

The policy statement, written by the AAP Committee on Drugs and Section on Clinical Pharmacology and Therapeutics, will publish in the June 2026 Pediatrics (published online May 26).

Today most medical professionals, insurance companies, and lawmakers support using generic drugs, so much so that the Food and Drug Administration reports that 91% of prescriptions in the U.S. are generic.

The AAP recognizes that generic drugs are just as safe and effective as brand-name ones, and they usually cost less.

“The AAP wants to assure families that generic drugs are often a cost-effective means of getting the treatment patients need,” said Jennifer Guimbellot, MDPhD, FAAP, an author of the policy statement and chair of the Section on Clinical Pharmacology and Therapeutics.

Policy statements created by AAP are written by medical experts, reflect the latest evidence in the field, and go through several rounds of peer review before being approved by the AAP Board of Directors and published in Pediatrics. 

The policy further explores the topic of biologics, powerful medications used to treat serious conditions like autoimmune diseases and certain cancers. These medications are made from living cells, which makes them more complex and expensive to create than traditional drugs.

Due to their complexity, scientists create biosimilars—medications that are similar in structure, safety, and efficacy but are not considered “generic.” The AAP supports greater access to these medications by decreasing costs and administrative burden.

“The potential for cost savings with biosimilars will not be fully realized until systems of pricing drugs including manufacturers, pharmacy benefit managers, insurance companies, and pharmacies coordinate passing the savings to patients,” Dr. Guimbellot said. “This is crucial for ensuring access to all patients in need so they can live the healthiest life possible.”

AAP recommends:

• Pediatric prescribers should trust substitutions for generic medications and so-called interchangeable biologics and prescribe them to patients in accordance with their needs and alongside the FDA’s most up-to-date version of the Approved Drug Products with Therapeutic Equivalence Evaluations.
• Health care entities, including payers, should establish and maintain committees that include pediatricians and pediatric pharmacists to guide substitutions with generic drugs and interchangeable biosimilars and to evaluate the rationale of the substitution based on available literature and/or federal agency recommendations.
• Academia, industry, and private drug developers invest in development of and research on generic, biosimilar, and interchangeable biosimilar agents in pediatric populations.
• Federal and state legislators, regulators, and government agencies promote rapid development, marketing, and research of generic, biosimilar, and interchangeable biosimilar agents in pediatric populations
• Manufacturers price generic and biosimilar agents lower than reference products to minimize adverse financial effects on pediatric prescribers, pediatric patients’ families, and administrating medical institutions
• Manufacturers, academic and medical organizations, payers, and government agencies should track and publish the patterns and financial effects of prescribing of generic and biosimilar agents in pediatric populations
• State legislatures harmonize across the nation state laws that regulate the prescribing of generic and biosimilar agents. The AAP and the federal government should encourage such harmonization. Federal regulation could help in this harmonization.

“The AAP affirms that it is ultimately the privilege and responsibility of the prescriber to choose the appropriate for each individual child or adolescent,” said Dr. Guimbellot. “The choice of a drug, dosing, and specific formulation should be specific to each child and treated condition.”

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The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults.

Source: American Academy of Pediatrics