Comparison of generic drug quality of Maribavir

Maribavir (Maribavir) is a therapeutic drug for cytomegalovirus (CMV). Its main function is to inhibit the pUL97 kinase of CMV, interfere with virus replication, and thereby control CMV infection. Maribavir has been marketed in many countries and is widely used in adult and pediatric patients who are resistant to traditional antiviral drugs (such as ganciclovir, valganciclovir, cidofovir). Despite the remarkable therapeutic effects of maribavivir, demand for generic drugs is gradually increasing in the market due to its higher cost.

Currently, there are no generic versions of maribavivir on the market. Although many drugs will face the entry of generic drugs into the market globally, as a newer drug, maribavivir’s research and development of generic drugs has progressed slowly. The quality comparison of generic drugs is a complex topic, mainly involving the active ingredients, dosage forms, stability and bioequivalence of the drugs.

First, generic drugs must exert the same therapeutic effect in the same dosage form and route of administration as the original drug. For antiviral drugs with specific target effects such as maribavavir, the development of generic drugs needs to ensure that their drug release rate and bioavailability in the body are consistent with those of the original drugs. Bioequivalence is a key indicator to measure the similarity of the effects of generic drugs and original drugs. It ensures that patients can obtain the same clinical effects when using generic drugs as when using original drugs.

In addition, the stability of generic drugs is also crucial. Maribavir is an oral drug, and its stability directly affects its efficacy. If the stability of the generic drug is not as good as that of the original drug, it may weaken the efficacy of the drug and even increase the risk of adverse reactions for patients. Therefore, strict quality control and stability testing are required before generic drugs enter the market.

Although there is currently no generic version of Maribavir, as the original drug patent expires and market demand increases, many pharmaceutical companies may develop and launch standard-compliant generic drugs in the future.

Reference materials:https://go.drugbank.com/drugs/DB06234