The difference between original drugs and generic drugs: sotorasib

Sotorasib (AMG510, Sotorasib) is the first KRAS G12C mutation-specific inhibitor that has been approved for marketing by the U.S. FDA and the European EMA. As an original drug, it was developed and commercialized by Amgen, marking a breakthrough in the "undruggable" era of KRAS. It is used to treat non-small cell lung cancer (NSCLC) and colorectal cancer . However, the differences between the original drug and generic drugs of sotorasibu have aroused widespread concern in the global pharmaceutical market. Original drugs are versions produced by the original R&D company, supported by complete intellectual property rights and clinical data, and have high standards of process control and consistency verification. Taking sotoracib as an example, its original research specification is 120mg/tablet, each bottle contains 240 tablets, and its sales price in international markets (such as the United States or Singapore) is as high as RMB 80,000. In the European market, the price has dropped to about more than 40,000 yuan.

At the same time, generic drugs, as versions that are not originally developed but are highly similar in ingredients, dosage and pharmacological effects, have gradually become an economic alternative for some patients. In some overseas countries such as Laos and India, generic versions of sotolasibu produced by local pharmaceutical companies such as Lucius have also been launched. For example, the price of 120mg*56 tablets is about more than one thousand yuan, and the price gap is significant. Although these generic drugs are almost identical in structure and main ingredients, they have not obtained formal marketing authorization in China or Europe and the United States, and lack strict clinical equivalence verification, so there are potential risks when using them.

From the perspective of efficacy, original drugs are usually accompanied by complete clinical pathways, safety assessments, stability studies, and production standards comply with European and American regulations. Generic drugs may have slight differences in the source of raw materials, preparation technology and bioavailability, and some patients may face problems with less-than-expected efficacy or fluctuating side effects. Therefore, when choosing sotoracib, if economic conditions permit, the original drug is undoubtedly a safer choice; but for some patients with limited funds, obtaining quality generic drugs through compliance channels also provides a realistic option for maintenance treatment.

Reference materials:https://www.lumakras.com/