Is there any generic version of sotorasib (AMG 510) and comparison of efficacy of different versions?

Sotorasib (AMG 510) is the world's first approved KRAS G12C inhibitor, which is a milestone for patients with non-small cell lung cancer who carry this mutation. However, this drug is not currently available in China, and patients can only rely on overseas channels to purchase it. There are mainly two versions in the overseas market. One is the original drug produced by Amgen, which is commonly found in the European version and the Hong Kong version. It is expensive, mostly at the level of tens of thousands or even tens of thousands of yuan. The second is that some countries and regions have already launched generic drugs, providing patients with a more economical choice.

From the perspective of efficacy, the original research version of sotorasibu has been verified by a large number of clinical trials, and its objective response rate and progression-free survival performance in patients with KRAS G12C mutated lung cancer are relatively outstanding. In contrast, the effectiveness of generic drugs mainly depends on their equivalence to the ingredients, dosage and mechanism of action of the original drug. According to actual patient feedback, the current clinical performance of generic drugs in Laos and other places is similar to that of the original drugs. Most patients have reduced tumor burden and improved symptoms such as breathing and coughing after taking the drug, indicating that the generic version still has high credibility in terms of efficacy.

In terms of safety, there is also little difference between original drugs and generic drugs. Common side effects of sotoraxib include diarrhea, nausea, increased liver function indicators, fatigue, etc. Most cases are mild to moderate and can be alleviated through symptomatic treatment. Patients who have used the Lao version of the generic drug have reported that its side effect spectrum is basically the same as that of the original drug, and there are no obvious additional adverse reactions. This shows to a certain extent that the safety of generic drugs is still within the acceptable range and long-term use is still feasible.

The difference in price is significant. The selling price of original drugs overseas remains high, placing a heavy financial burden on patients. Recently, the price of generic drugs produced by Laos Lucius (Lucius) and Laos Beacon (Beacon) has dropped significantly. The specification of 120mg*56 tablets only costs more than 1,000 yuan. Compared with the original drug, which is often priced in tens of thousands of yuan, it is obviously more accessible. For patients who require long-term medication, Laotian generic drugs will undoubtedly reduce their financial pressure and also expand the actual accessible population of sotorasibu.

Reference link:https://www.drugs.com