Differences and advantages between domestic tablets and imported drugs of Pitobrutinib/Pirtobrutinib

Pitobrutinib/Pirtobrutinib (Pirtobrutinib) is a new generation Bruton's tyrosine kinase (BTK) inhibitor, mainly used for relapsed or refractory diseaseBcell malignancies, such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). At present, there are no domestic tablets of Pitobrutinib in China, and only original imported drugs are on the market, which means that patients mainly rely on overseas channels for purchase and use. Original drugs have been verified through rigorous clinical trials and are fully guaranteed in terms of efficacy, stability and safety, which is one of its significant advantages.

The original drug pitubrutinib has a high degree of consistency in the drug preparation process, ensuring that the active ingredients and bioavailability of each batch of drugs are stable, so that patients can obtain sustained and predictable efficacy during the treatment process. Compared with possible future domestic generic drugs, the clinical data of original drugs is more complete, covering the dosage, efficacy evaluation and adverse reaction monitoring of the drug, which can provide doctors with accurate medication reference, reduce treatment risks, and improve patients' confidence in medication.

In addition, the original pitubrutinib also has certain advantages in dosage form and packaging. Oral tablets make it easier for patients to self-manage their medication and ensure medication compliance. The accompanying medication instructions describe in detail dosage adjustment, adverse reaction management and combined medication precautions, providing patients with comprehensive medication guidance. For high-risk patients, such as those with liver and kidney dysfunction or other diseases, the safety data and dosage guidance of the original drug are particularly important, which can effectively reduce the incidence of adverse events during treatment.

In general, although there are currently no domestic tablets of pitubrutinib in China, the original imported drug has obvious advantages in terms of efficacy, drug stability, completeness of clinical data and drug safety. This is a reliable treatment option for patients with relapsed or refractory B cell malignancies. In the future, if domestic tablets are launched on the market, there may be improvements in price and accessibility, but the advantages of original drugs in clinical verification and drug safety are still difficult to replace.

Reference materials:https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216059s002lbl.pdf